среда, 30 апреля 2008 г.

Death in childbirth: A health scourge for Afghanistan (Reuters)

Only News Photos Video/Audio DEATH IN CHILDBIRTH: A HEALTH SCOURGE FOR AFGHANISTAN By Tan Ee Lyn _2 hours, 1 minute ago_ FAIZABAD, Afghanistan (Reuters) - A woman hemorrhages to death as she lies screaming in agony in a Spartan hut in a remote region of Afghanistan.Is no doctor or midwife to help and the hospital is several days journey away.Women die this way every day in Afghanistan, a country with one of the worlds highest maternal mortality rates.About 1,600 Afghan women die in childbirth out of every 100,000 live births.Some of the most remote areas, the death rate is as high as 6,500.The average rate in developing countries is 450 and in developed countries it is 9.Virtually everyone in Afghanistan can recount a story about a relative dying in childbirth, often from minorplications that can be easily treated with proper medical care.Sharifas sister, a mother of six, bled to death after giving birth at home."There is no clinic, no cars, no proper roads.Is a remote village, we could not take her to hospital.At home for one day and one night, then she died," recalled Sharifa, who identified herself only by her first name.Afghanistans government aims to reduce maternal mortality by 20 percent by 2020 but there are many obstacles to ovee such as a reluctance by women to be examined by male doctors and a lack of female doctors, nurses and midwives.Then there are the vast distances in this war-torn country where hospitals are generally poorly equipped and medical help is inaccessible to those living in remote locations.HOME BIRTHS It is an age old practice for Afghan women in rural areas to deliver babies at home.Midwives are rarely in attendance.There areplications, it might take hours, even days to reach the nearest clinic.Even when women with laborplications get to hospital alive, there are often no doctors or medical equipment to perform caesarean sections and other life saving procedures."In some places, there arent even operating theatres and women just wait for their death," said Rona Azamyan, who coordinates the Midwifery Education Programme in Faizabad.Among the primeplications of childbirth in Afghanistan are bleeding, infection, hypertension and obstructed labour.It is not umon for girls as young as 13 to marry in Afghanistan and there are oftenplications when they give birth."The mothers are very young, so their (pelvic) bone development is immature," said Karima Mayar, a family planning team leader at the Ministry of Public Health.Poor and malnourished, many pregnant women in Afghanistan are severely anemic."If they get post-partum hemorrhage, they will die 100 percent of the time," said Mayar.Womens access to healthcare has generally been poor in deeply conservative Afghanistan.Afghan men prefer their women to consult only women doctors, but that is easier said than done in a society where there are few female doctors and nurses and little emphasis is placed on educating girls.The problem got worse during the Taliban regime, when girls were banned from schools and there were severe restrictions placed on women leaving their homes.During those years, from 1996 to 2001, there were only around 1,000 female healthcare workers in the whole country, staffing female-only hospitals.But the situation is still far from ideal now, more than six years after the fall of the Taliban, even in places such as the northeastern province of Badakhshan where the town of Faizaban is located.Area is far from fighting with Taliban insurgents.Only 66 percent of basic healthcare centers have at least one female health worker.Make up only 23.Of the countrys healthcare workforce and 27 percent of its nursing staff.MATERNAL DEATH "One woman dies every 27 minutes in Afghanistan due toplications in childbirth & and the tragedy doesnt stop with the mothers death," said Mayar."When the mother of a newborn dies, 75 percent of these babies die.Feed them, keep them warm?An Afghan saying: When the mother dies, the child is sure to die.The government plans to distribute the drug misoprostol to pregnant women in 13 provinces this year."We will distribute this to women in their seventh month of pregnancy and they must take it right after delivery.Will remove the placenta and prevent hemorrhage," Mayar said.In the pipeline are plans to set up more midwifery schools and assign more female students to medical and nursing schools."To reduce maternal mortality, we need 8,000 midwives by 2010 to cover needs of all pregnant women," said Mayar.Are 2,143 midwives in the country of 26 million people.But years of neglecting girls education is taking its toll."In the provinces, the maximum level of education is the 10th grade, but the minimum requirement for entry into nursing school is 12th grade," said Fatima Mohbat Ali of the Aga Khan Foundation, an aid group in Afghanistan.Some progress has been made in recent years, owing to government and NGO efforts to improve rural healthcare.In Badakhshans Eshkashem district, which borders Tajikistan, Afghan women have been frequenting the health clinic, the most modern looking facility in a town where most of the 13,000 residents live in mud houses.From headaches to prenatal checkups, childbirth and advice on contraception, women have been bringing theirplaints to the clinics female doctor for the last three years.Since we got an ambulance, a lady doctor, two midwives and an operating theatre three years ago, we have not had a single case of maternal mortality," said Abdi Mohammad, head of the Eshkashem health clinic and an obstetric surgeon.(Editing by Megan Goldin) Yahoo!THIS STORY Rmend It: Not at All Somewhat Moderately Highly Very Highly Average (Not Rated) _AP_ _AP_ _AP_ _AP_ _AP_ _AFP_ _Reuters_ _Reuters_ _Reuters_ _AP_ _ FOX News - Tue Apr 29, 5:10 PM ET_ _ CNN - Tue Apr 29, 4:46 PM ET_ _ CNN - Tue Apr 29, 9:31 AM ET_ _ ABC News - Tue Apr 29, 10:38 AM ET_ Sponsored Links ( ) $300,000 Mortgage for only $965/month.$1,000's - No obligation. Get a Degree in as Few as 2 Yrs- Graduate Faster with Online Classes. An Afghan mother holds her child as she visits a health clinic in Eshkashem district. Health Video Yahoo!Topic Pages Get in-depth coverage on and with new topic pages.Elsewhere On The Web ABC NEWS: ABC NEWS: TIME: YAHOO!How to give and get perfectly good stuff for free, reducing waste.From Y!Find answers on Yahoo!Add Headlines To Your Personalized My Yahoo!Parenting/Kids News NEWS ALERTS __ Get an alert when there are new stories about: seventh month of pregnancy female doctors and nurses contraception Aga Khan Foundation Tajikistan - - SEARCH: All News Yahoo!Only News Photos Video/Audio PRIMARY NAVIGATION Copyright 2008 Reuters Limited.Reserved.
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вторник, 29 апреля 2008 г.

Aspirin-like compounds (salicylates) increase insulin secretion in otherwise healthy obese people

And other salicylates are known to reduce blood glucose in diabetic patients.Research accepted for publication in the Journal of Clinical Endocrinology & Metabolism reveals a similar beneficial effect among obese individuals by increasing the amount of insulin secreted into the bloodstream."The administration of a salicylate led to the lowering of serum glucose concentrations," said Jose-Manuel Fernandez-Real of the Institut d'Investigacio Biomedica de Girona and CIBEROBN Fisiopatologia de la Obesidad, Spain, and lead author of the study.Highlight the importance of further research on the possible therapeutic benefit of aspirin in the fight against type 2 diabetes.For their study, Fernandez-Real and his colleagues evaluated the effects of triflusal (a derivative of salicylate) on 28 subjects (nine men and 29 women).Average age of the participants was 48 years old and their average Body Mass Index (BMI) was 33.A BMI of over 30 is considered obese.Three, four-week treatment periods, the study participants received a 600 mg dose, a 900 mg dose, or a placebo once per day.The researchers found that administration of triflusal led to decreased fasting serum glucose.To their expectations, insulin sensitivity did not significantly change during the trial.However, significantly increased in relation to the dose size.In conjunction with the human studies, the researchers also conducted laboratory studies on insulin-producing cells (known as islets of Langerhans) from mice and humans.Researchers observed that triflusal significantly increased the insulin secreted by these cells."Aspirin therapy has been recognized to improve glucose tolerance and to reduce insulin requirements in diabetic subjects," said Fernandez-Real.Our knowledge, this is the first study to show that salicylates lowered serum glucose in non-diabetic obese subjects.That this effect was due to a previously unsuspected increase in insulin secretion rather than enhanced insulin sensitivity.Would you like to for our weekly ?The end of each week we'll send you an email containing links to the most popular articles (by page impression) from your chosen categories that appeared on News-Medical.That week.Will NOT be bombarded with advertising and you CAN unsubscribe at any time.More information or click here to view our .News-Medical.The worthy medical information: .Health News Disease/Infection News Devices/Technology News Healthcare News Medical Conditions Medical Procedures Medical Patent News Medical Research News Men's Health News Medical Science News Miscellaneous News Pharmaceutical News Medical Studies/Trials Women's Health News < Jump to News-Medical.This service in accordance with these .Please note that found on this website is designed to support, not to replace the relationship between patient and physician/doctor and the medical advice they may provide.
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понедельник, 28 апреля 2008 г.

Amgen's First Quarter 2008 Adjusted Earnings Per Share Increased 4 percent to $1.12

WORLD PHARMA NEWS .PUBLISHED NEWS OUR RSS NEWS CHANNELS SPONSORED ADS Amgen's First Quarter 2008 Adjusted Earnings Per Share Increased 4 percent to $1.Monday, 28 April 2008 Amgen (NASDAQ:AMGN) reported adjusted earnings per share (EPS), excluding stock option expense and certain other expenses, of $1.Quarter of 2008, an increase of 4 percentpared to $1.First quarter of 2007.Net ie, excluding stock option expense and certain other expenses, decreased 4 percent to $1,218 million in the first quarter of 2008pared to $1,270 million in the first quarter of 2007.Option expense on a per share basis totaled 2 cents and 3 cents for the first quarter of 2008 and 2007, respectively.Total revenue decreased 2 percent during the first quarter of 2008 to $3,613 million versus $3,687 million in the first quarter of 2007.Adjusted EPS and adjusted net ie for the first quarter 2008 and 2007 exclude, for the applicable periods, stock option expense, certain expenses related to acquisitions, restructuring charges and certain other items.Expenses and other items are itemized on the attached reconciliation tables.EPS including the impact of stock option expense are also itemized in the notes to the attached reconciliation tables.On a reported basis and calculated in accordance with United States (U.Generally Accepted Accounting Principles (GAAP), Amgen's GAAP EPS were $1.The first quarter of 2008, an 11 percent increasepared to $0.The same quarter last year.Net ie increased 2 percent to $1,136 million in the first quarter of 2008 from $1,111 million in the first quarter of 2007.First quarter product sales were mixed, based on current trends and expectations, we are confident that revenues for the year will be within our previously announced guidance," said Kevin Sharer, chairman and CEO.Continue to be encouraged by the lasting effects of our cost management efforts.
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воскресенье, 27 апреля 2008 г.

[membrane transport, structure, function, and biogenesis] identification of amino acid residues within the c terminus of the glut4 glucose transporter that are essential for insulin-stimulated redistribution to the plasma membrane

Chem.283, Issue 18, 12571-12585, May 2, 2008 This Article All Versions of this Article: 283/18/12571 _most recent_ Services Google Scholar PubMed IDENTIFICATION OF AMINO ACID RESIDUES WITHIN THE C TERMINUS OF THE GLUT4 GLUCOSE TRANSPORTER THAT ARE ESSENTIAL FOR INSULIN-STIMULATED REDISTRIBUTION TO THE PLASMA MEMBRANE XIAO MEI SONG, RICHARD C.AND MIKE MUECKLER1 From the Department of Cell Biology and Physiology, Washington University School of Medicine, St.Missouri 63110 The Glut4 glucose transporter undergoesplex insulin-regulated subcellular trafficking in adipocytes.Effort has been expended in an attempt to identify targeting motifs within Glut4 that direct its subcellular trafficking, but an amino acid motif responsible for the targeting of the transporter to insulin-responsive intracellularpartments in the basal state or that is directly responsible for its insulin-stimulated redistribution to the plasma membrane has not yet been delineated.This study we define amino acid residues within the C-terminal cytoplasmic tail of Glut4 that are essential for its insulin-stimulated translocation to the plasma membrane.Residues were identified based on sequence similarity (L_XX_L_X_PDE_X_D) between cytoplasmic domains of Glut4 and the insulin-responsive aminopeptidase (IRAP).Of this putative targeting motif (IRM, insulin-responsive motif) resulted in the targeting of the bulk of the mutant Glut4 molecules to dispersed membrane vesicles that lacked detectable levels of wild-type Glut4 in either the basal or insulin-stimulated states andpletely abolished the insulin-stimulated translocation of the mutant Glut4 to the plasma membrane in 3T3L1 adipocytes.Bulk of the dispersed membrane vesicles containing the IRM mutant did not contain detectable levels of any subcellular marker tested.Fraction of the total IRM mutant was also detected in a wild-type Glut4/Syntaxin 6-containing perinuclearpartment.Mutation of the IRM sequence did not appreciably alter the subcellular trafficking of IRAP.Conclude that residues within the IRM are critical for the targeting of Glut4, but not of IRAP, to insulin-responsive intracellular membrane 1 To whom correspondence should be addressed: Dept.Cell Biology, Washington University Medical School, 660 Euclid Ave.Box 8228, St.MO 63110.
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суббота, 26 апреля 2008 г.

Biochemical mechanism of healing activity of the natural phenolic, allylpyrocatechol against indomethacin-induced gastric ulceration in mice

You have forgotten your username or password, we can .My Menu Saved Items дё­ж–‡(з®ЂдЅ") дё­ж–‡(з№Ѓй«") English Deutsch н•њкµ­м–ґ ж—Ґжњ¬иЄћ Franais Espaol Ш§Щ„Ш№Ш±ШЁЩЉШ© Р СѓСЃСЃРєРёР№ Journal Article BIOCHEMICAL MECHANISM OF HEALING ACTIVITY OF THE NATURAL PHENOLIC, ALLYLPYROCATECHOL AGAINST INDOMETHACIN-INDUCED GASTRIC ULCERATION IN MICE Journal Publisher Springer Netherlands ISSN 0163-2116 (Print) 1573-2568 (Online) Category Original Paper DOI 10.Subject Collection SpringerLink Date Wednesday, April 23, 2008 ORIGINAL PAPER Biochemical Mechanism of Healing Activity of the Natural Phenolic, Allylpyrocatechol Against Indomethacin-Induced Gastric Ulceration in Mice Debashish Banerjee1, Sayanti Bhattacharya1, Sandip K.And Subrata Chattopadhyay2 (1) Department of Biochemistry, Dr. Roy Post Graduate Institute of Basic Medical Sciences " OnMouseOut="className='advancedTextBoxExpandButton buttonContainer';" /> Query Builder Close Clear Within all content Within this journal Export this article Export this article as RIS Text В© Springer.
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пятница, 25 апреля 2008 г.

Hypoglycaemia in patients with type 2 diabetes treated with a combination of metformin and sulphonylurea therapy in france

G.R.Yin (2008) Hypoglycaemia in patients with type 2 diabetes treated with abination of metformin and sulphonylurea therapy in France Diabetes, Obesity and Metabolism 10 (s1) , 16-24 doi:10.00883.Abstract ORIGINAL ARTICLE HYPOGLYCAEMIA IN PATIENTS WITH TYPE 2 DIABETES TREATED WITH ABINATION OF METFORMIN AND SULPHONYLUREA THERAPY IN FRANCE P.P.G.Lyu and D.Health Oues Research & Health Technology Assessment, Merck & Co.Whitehouse Station, NJ, USADonald Yin, PhD, Merck & Co.One Merck Drive, Whitehouse Station, NJ 08889, USA.Of Diabetology and Endocrinology, Hpital Saint-Louis, Assistance publique - Hpitaux de Paris, Paris, France 2Global Health Oues Research & Health Technology Assessment, Merck & Co.Whitehouse Station, NJ, USA 3Oues Research, Bristol Myers Squibb, Princeton, NJ, USA Donald Yin, PhD, Merck & Co.One Merck Drive, Whitehouse Station, NJ 08889, USA.INTEREST: D.Is an employee and share holder of Merck & Co.M.An employee of Merck & Co.And holds stock of this corporation.L.Employee & share holder of Merck & Co.K.An employee of Merck & Co.The time the paper was written.V.Declared no conflicts of interest.Yet, the impact of hypoglycaemia on quality of life in these patients is not well documented.Examine patient-reported experience of hypoglycaemia, worry about hypoglycaemic symptoms and the impact of hypoglycaemia on patients' quality of life associated with use of sulphonylurea co-administered with metformin.Was an observational, cross-sectional, multi-centre study.Total of 98 primary care centres in France during October to December 2005.Total of 400 patients with type 2 diabetes, who were 35 years old and who had been treated with metformin and a sulphonylurea for at least 6 months,pleted questionnaires during their usual primary care office visit.Measures: Frequency and severity of hypoglycaemic symptoms in the past 6 months, the Worry subscale of the Hypoglycaemic Fear Survey-II (HFS-II) and the EuroQol-5 Dimensions (EQ-5D) questionnaire.Total of 136 (34%) patients reported experiencing hypoglycaemia, of whom 78 (58%) experienced mild, 40 (30%) experienced moderate and 16 (12%) experienced severe or very severe symptoms.On the HFS-II Worry scale was higher for patients who reported having hypoglycaemia than for those who did not (19.10.< 0.With severity of hypoglycaemic symptoms.Linear regression analyses, more severe symptoms of hypoglycaemia were significantly associated with higher scores on the HFS-II Worry scale (p = 0.With hypoglycaemic symptoms.Scores on the EQ-5D were lower for patients who reported hypoglycaemia than for those who did not (p = 0.In multivariate analysis, the experience of hypoglycaemia was negatively associated with the EQ-5D summary score (p < 0.Conclusion: The occurrence and severity of hypoglycaemic symptoms were associated with increased patient worry about hypoglycaemia and lower health-related quality of life among type 2 diabetic patients being treated with both metformin and a sulphonylurea.THIS ARTICLE SEARCH InSynergyPubMed (MEDLINE)CrossRefBy keywordsdiabetesFrancehypoglycaemiametforminquestionnairesulphonylureaworryBy authorP.MavrosG.
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четверг, 24 апреля 2008 г.

Long-term safety and efficacy of a combination of niacin extended release and simvastatin in patients with dyslipidemia: the oceans study

Contact us to report problems with: For Publishers For Researchers For Librarians LONG-TERM SAFETY AND EFFICACY OF ABINATION OF NIACIN EXTENDED RELEASE AND SIMVASTATIN IN PATIENTS WITH DYSLIPIDEMIA: THE OCEANS STUDY AUTHORS: Karas, Richard H.Moti L.Robert H.H.Daiva R.Michael H.SOURCE: , Volume 8, Number 2, 2008 , pp.PUBLISHER: Key: - Free Content - New Content - Subscribed Content - Free Trial Content ABSTRACT: INTRODUCTION: High-dose HMG-CoA reductase inhibitors (statins) fail to prevent approximately two-thirds of cardiovascular events.Fact has focused increased attention on treating abnormalities of non-high-density lipoprotein-cholesterol (non-HDL-C), HDL-C, and triglycerides in national guidelines and has intensified interest inbination therapy.OCEANS study (Open-label evaluation of the safety and efficacy of abination of niacin ER and simvAstatin in patieNts with dySlipidemia; ClinicalTrials.NCT00080275) evaluated the safety and efficacy of abination of niacin extended release and simvastatin (NER/S; SIMCOR(R)) over 52 weeks in 520 patients with mixed dyslipidemia.A 4-week run-in phase of diet modification and simvastatin 40 mg/day, median baseline values (mg/dL) were: non-HDL-C = 141, low-density lipoprotein-cholesterol (LDL-C) = 110, HDL-C = 45, and triglyceride = 151.Were randomized to an 8- or 12-week niacin titration scheme to a maximum NER/S dosage of 2000/40 mg/day.Between titration groups in tolerability, safety, and efficacy were minimal; therefore, all results are for pooled titration groups.Safety of NER/S was consistent with the safety profile of each individualponent.With NER/S was well tolerated: 71% of patients experienced flushing and 92% of flushing episodes were mild or moderate in intensity.61% of patients experienced flushing episodes that were rated as mild or moderate in intensity.Decreased over time: 40% of those who had flushing during titration experienced flushing during the final 12 weeks.Of 20% of patients discontinued treatment because of a treatment-related adverse event, including 7% who discontinued because of flushing.Changes from baseline (following the simvastatin 40 mg/day run-in phase) to 24 weeks were: non-HDL-C = -27.= -25.= +23.Triglycerides = -35.P 0.Baseline).Patients, NER/S 2000/40 mg/day decreased non-HDL-C, LDL-C, and triglycerides by approximately 50% and increased HDL-C by approximately 25% when week-24 lipid values werepared with lipid values obtained prior to the simvastatin 40 mg/day run-in.Therapeutic lipid targets (LDL-C , HDL-C 40 mg/dL, and triglycerides 150 mg/dL) were achieved concurrently by 65% of patients treated with NER/S.With NER/S 2000/40 mg/day is well tolerated, has no unanticipated adverse events, and provides additional, clinically relevant improvements in multiple lipid parameters beyond statin monotherapy.KEYWORDS: ; ; ; ; ; ; ; DOCUMENT TYPE: Research article AFFILIATIONS: 1: 1 Division of Cardiology, Molecular Cardiology Research Institute, Tufts Medical Center, Boston, Massachusetts, USA 2: 2 Department of Veterans Affairs Medical Center, Atherosclerosis Research Center, Long Beach, California, USA 3: 3 Division of Metabolism, Northwest Lipid Research Clinic, Endocrinology and Nutrition, University of Washington School of Medicine, Seattle, Washington, USA 4: 4 Abbott, Weston, Florida, USA 5: 5 Division of Cardiology, University of Chicago, Chicago, Illinois, USA This feature is in beta and some links may initially be displayed as numbers instead of article titles.On any of the links will take you to the rmended articles, regardless of the display of the link.The full text article is available for purchase $54.TAX Pressing the buy now button more than once may result in multiple purchases CREDIT/DEBIT CARD INSTITUTIONAL PAYMENT ACCOUNT OR Purchase later Key: - Free Content - New Content - Subscribed Content - Free Trial Content Website 2008 Ingenta.
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среда, 23 апреля 2008 г.

Botulinum toxin type a injections into the calf muscles for treatment of spastic equinus in cerebral palsy: a randomized trial comparing single and multiple injection sites.

ARTICLE LINKS: BOTULINUM TOXIN TYPE A INJECTIONS INTO THE CALF MUSCLES FOR TREATMENT OF SPASTIC EQUINUS IN CEREBRAL PALSY: A RANDOMIZED TRIALPARING SINGLE AND MULTIPLE INJECTION SITES.ORIGINAL RESEARCH ARTICLE American Journal of Physical Medicine Pietikainen, Tarja PT; Iisalo, Terhi PT; Lehtonen-Raty, Pirjo PT; Salo, Marja PT; Haataja, Riina MSc; Koivikko, Matti PhD; Autti-Ramo, Ilona PhD _ ABSTRACT: Satila H, Pietikainen T, Iisalo T, Lehtonen-Raty P, Salo M, Haataja R, Koivikko M, Autti-Ramo I: Botulinum toxin type a injections into the calf muscles for treatment of spastic equinus in cerebral palsy: a randomized trialparing single and multiple injection sites.Phys Med Rehabil 2008;87:386-394.Investigate the hypothesis that the multiple-site injection technique is associated with better oues than the single-point injection method in children with cerebral palsy and spastic equinus gait.Total of 17 children (nine boys, eight girls ages 1.Yrs; eight hemiplegics, eight diplegics, one quadriplegic; levels I-IV with the Gross Motor Function Classification System) with 25 treated lower limbs were randomized into two groups: a single-point group receiving a standard dose of botulinum toxin A injection into one site and a multiple-points group into two sites on both heads of the gastrocnemius.And passive range of movement, selective dorsiflexion, dynamic muscle length (modified Tardieu scale), calf tone (modified Ashworth scale), attainment of anticipated gait pattern (Goal Attainment Scale), and video gait analysis (Observational Gait Scale ) were assessed before and 1, 2, and 4 mos after intervention.Groups improved in dynamic muscle length, muscle tone, OGS-total scores and initial foot contact scores and a similar number of children attained their goals on the Goal Attainment Scale.Only significant difference between the groups was observed at 2 mos in passive dorsiflexion with the knee flexed, favoring the single-point group.Not significantly, the incidence of adverse effects was higher in the multiple-points group.The methods described, no major changes in main oue measures were associated with the number of injection sites.Than efficacy guide the decision on whether to inject in single or multiple sites when treating spastic equinus with botulinum toxin.Lippincott Williams & Wilkins, Inc.2008, Association of Academic Physiatrists.Rights reserved.By Lippincott Williams & Wilkins.
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вторник, 22 апреля 2008 г.

Azathioprine/methylprednisolone/tacrolimus: cns disorders associated with cryptococcal infection in a liver transplant recipient: case report

Contact us to report problems with: For Publishers For Researchers For Librarians AZATHIOPRINE/METHYLPREDNISOLONE/TACROLIMUS: CNS DISORDERS ASSOCIATED WITH CRYPTOCOCCAL INFECTION IN A LIVER TRANSPLANT RECIPIENT: CASE REPORT SOURCE: , Volume 1, Number 1198, 2008-04-19 , pp.PUBLISHER: Key: - Free Content - New Content - Subscribed Content - Free Trial Content KEYWORDS: ; ; ; ; ; ; ; DOCUMENT TYPE: Shortmunication This feature is in beta and some links may initially be displayed as numbers instead of article titles.Any of the links will take you to the rmended articles, regardless of the display of the link.The full text article is available for purchase $34.TAX Pressing the buy now button more than once may result in multiple purchases CREDIT/DEBIT CARD INSTITUTIONAL PAYMENT ACCOUNT OR Purchase later Key: - Free Content - New Content - Subscribed Content - Free Trial Content Website 2008 Ingenta.
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понедельник, 21 апреля 2008 г.

Formulation and characterization of mucoadhesive buccal films of glipizide

Garhwal University, Srinagar (UA) - 246 174, India 2 Department of Pharmacy, S.R.I.S.Dehradun - 248 001, India Date of Submission 10-Oct-2006 Date of Decision 15-Nov-2007 Date of Acceptance 15-Jan-2008 CORRESPONDENCE ADDRESS: Semalty Mona Department of Pharmaceutical Sciences, H.B.University, Srinagar (UA) - 246 174 India SOURCE OF SUPPORT: None, CONFLICT OF INTEREST: None Abstract Mucoadhesive buccal films of glipizide were prepared by solvent casting technique using hydroxypropylmethylcellulose, sodium carboxymethylcellulose, carbopol-934P and Eudragit RL-100.Were evaluated for weight, thickness, surface pH, swelling index, _ in vitro_ residence time, folding endurance, _ in vitro_ release, permeation studies and drug content uniformity.Films exhibited controlled release over more than 6 h.The study it was concluded that the films containing 5 mg glipizide in 4.And 1.Sodium carboxymethylcellulose exhibited satisfactory swelling, an optimum residence time and promising drug release.Formulation was found to be suitable candidate for the development of buccal films for therapeutic use.Buccal film, glipizide, _ in vitro_ studies HOW TO CITE THIS ARTICLE: Semalty M, Semalty A, Kumar G.And characterization of mucoadhesive buccal films of glipizide.J Pharm Sci 2008;70:43-8 HOW TO CITE THIS URL: Semalty M, Semalty A, Kumar G.And characterization of mucoadhesive buccal films of glipizide.J Pharm Sci ;70:43-8.Amongst the various routes of administration tried so far for novel drug delivery systems, localized delivery to tissues of the oral cavity has been investigated for a number of applications including the treatment of toothaches , periodontal disease , , bacterial and fungal infections , aphthous and dental stomatitis and in facilitating tooth movement with prostaglandins .The last two decades mucoadhesion has be of interest for its potential to optimize localized drug delivery, by retaining a dosage form at the site of action (e.Within gastrointestinal tract) or systemic delivery, by retaining a formulation in intimate contact with the absorption site (e.The buccal cavity).Maybe defined as a state in which two materials, one of which is mucus or a mucous membrane, is held together for extended period of time .Jasti _ et al.Et al.Semalty _ et al.Reviewed the use of mucoadhesive polymers in buccal drug delivery and highlighted the use of novel mucoadhesive polymers ,, .Studies have been conducted on buccal delivery of drugs using mucoadhesive polymers.Been made to formulate various mucoadhesive devices including tablets , films , patches , , disks , , strips , ointments and gels .Film may be preferred over adhesive tablet in terms of flexibility andfort.Addition, they can circumvent the relatively short residence time of oral gels on the mucosa, which are easily washed away and removed by saliva.Buccal films are able to protect the wound surface, thus reducing pain and treating oral diseases more effectively .A second generation sulfonylurea used as an antidiabetic agent.Is one of the most potent of the sulfonylurea antidiabetic agents.Is 100 times more potent than tolbutamide in evoking pancreatic secretion of insulin .Differs from other oral hypoglycemic drugs in that tolerance to its action apparently does not occur.Also upregulates insulin receptors in the periphery, which seems to be the primary action.Short biological half-life (3.0.Necessitates its administration in 2 or 3 doses of 2.10 mg per day.About 90% of the drug is metabolized in the liver forming several inactive metabolites .An attempt has been made to develop a buccal mucoadhesive dosage form of glipizide for improving and enhancing bioavailability in a controlled release fashion.May also be possible to circumvent the hepatic first pass effect by administering the drug through buccal mucosa.Work deals with the formulation and characterization of mucoadhesive buccal films of glipizide using mucoadhesive polymers like hydroxy propylmethylcellulose, Carbopol-934P, Eudragit RL-100 and sodium carboxymethylcellulose.And Methods Glipizide was obtained as a gift sample from USV Ltd (Daman, India).Carbopol-934P (CP-934P), Eudragit RL-100 and sodium carboxymethylcellulose, 1500-400cps (SCMC) were procured from Central Drug House, Mumbai.Glycol was procured from E.(P) Ltd, Mumbai.Other reagents used were of analytical grade.Films were prepared by solvent casting method.Of mucoadhesive buccal films: Buccal films of glipizide were prepared by solvent casting technique employing aluminum foil cups (placed on glass surface) as substrate .A single circular cast film of various formulations is mentioned in .Were prepared by using HPMC-E15 alone and inbination with CP-934P, Eudragit RL-100 and sodium CMC (high viscosity grade).Glycol, a plasticizer is used in the concentration of 30% w/w.Was used as a solvent.Amounts of polymers were dispersed in ethanol.Hundred milligrams of glipizide was incorporated in the polymeric solutions after levigation with 30% w/w propylene glycol which served the purpose of plasticizer as well as penetration enhancer.Medicated gels were left overnight at room temperature to obtain clear, bubble-free gels.Prevent the evaporation of alcohol, medicated gels were filled into the vials and closed tightly by the rubber closures.Gels were caste into aluminum foil cups (4.Diameter), placed on a glass surface and allowed to dry overnight at room temperature (25°) to form a flexible film.Dried films were cut into size of 20 mm diameter, packed in aluminum foil and stored in a desiccator until further use.Weight and thickness: For evaluation of film weight three films of every formulation were taken and weighed individually on a digital balance (Fisher Brand PS-200).Average weights were calculated.Films of each formulation were taken and the film thickness was measured using micrometer screw gauge (Mitutoyo MMO-25DS) at three different places and the mean value was calculated.PH of films: For determination of surface pH three films of each formulation were allowed to swell for 2 h on the surface of an agar plate.PH was measured by using a pH paper placed on the surface of the swollen patch.Mean of three readings was recorded .After determination of the original film weight and diameter, the samples were allowed to swell on the surface of agar plate kept in an incubator maintained at 37±0.Increase in the weight of the films (_ n_ = 3) was determined at preset time intervals (1-5 h).Percent swelling, %S, was calculated using the following equation: Percent Swelling (%S) = (X t - X o /X o ) x 100, where X t is the weight of the swollen film after time t, X o is the initial film weight at zero time .Endurance: Three films of each formulation of size (2 x 2 cm) were cut by using sharp blade.Was determined by repeatedly folding a small strip of film at the same place till it broke.Number of times, the film could be folded at the same place without breaking gave the value of folding endurance.Mean value of three readings and standard deviation were shown in .VITRO_ RESIDENCE TIME: The _ in vitro_ residence time was determined using IP disintegration apparatus.Disintegration medium was 800 ml of pH 6.Buffer (PB) maintained at 37±2°.Of rat intestinal mucosa, each of 3 cm length, were glued to the surface of a glass slab, which was then vertically attached to the apparatus.Mucoadhesive films of each formulation were hydrated on one surface using pH 6.And the hydrated surface was brought into contact with the mucosal membrane.Glass slab was vertically fixed to the apparatus and allowed to move up and down.Film waspletely immersed in the buffer solution at the lowest point and was out at the highest point.Time required forplete erosion or detachment of the film from the mucosal surface was recorded (_ n_ = 3) as given in .Content uniformity: Three film units (each of 20 mm diameter) of each formulation were taken in separate 100 ml volumetric flasks, 100 ml of pH 6.Buffer was added and continuously stirred for 24 h.Solutions were filtered, diluted suitably and analyzed at 274 nm in a UV spectrophotometer (Thermospectronic UV-1).Average of drug contents of three films was taken as final reading.VITRO_ RELEASE STUDY: The USP XXIV six station dissolution apparatus type 1 (V Scientific Model No.Was used throughout the study.Film of each formulation was fixed to the central shaft at just above the basket, using a cyanoacrylate adhesive.Dissolution medium consisted of 900 ml pH 6.Buffer (PB).Release study was performed at 37 ± 0.A rotation speed of 50 rpm.Release study was carried out for 6 h.Every hour, 1 ml sample was withdrawn from each station and the same volume was replaced (with the dissolution medium) back to the stations.Withdrawn sample was filtered, diluted suitably and then analyzed spectrophotometrically at 274 nm.Presented were the mean of three determinations.VIVO_ PERMEATION STUDIES: In this study, porcine buccal mucosa was used as a barrier membrane.Pouch of freshly sacrificed animal was procured from local slaughter house.Buccal mucosa was excised and trimmed evenly from the sides.Was then washed in isotonic phosphate buffer (pH 6.Immediately .Ex vivo_ permeation studies of mucoadhesive buccal films of glipizide through an excised layer of porcine buccal mucosa were carried out using the modified Franz diffusion cell .2.Diameter film of each formulation under study was placed in intimate contact with the excised porcine buccal mucosa and the topside was covered with aluminum foil as a backing membrane.Bead was placed in the receptorpartment filled with 100 ml of pH 7.Buffer.Cell contents were stirred with a magnetic stirrer and temperature of 37±1° was maintained throughout the experiment.Samples were withdrawn at every hour, filtered, diluted suitably and then analyzed using UV- spectrophotometer at 276 nm.Results and Discussion Mucoadhesive buccal films of glipizide were prepared using mucoadhesive polymers HPMC-E15, CP-934P, Eudragit RL-100 and sodium CMC.Glycol was used as the plasticizer as well as penetration enhancer.Drug delivery system was formulated as a matrix.Films were characterized for their physical characteristics, bioadhesive performance, release characteristics, surface pH, thickness, folding endurance, drug content uniformity and percent swelling .Film thicknesses were observed to be in the range of 0.Mm to 0.Mm and weight was found to be in the range of 56±1.To 84±0.The fact that acidic or alkaline pH may cause irritation to the buccal mucosa and influence the degree of hydration of polymers, the surface pH of the buccal films was determined to optimize both drug permeation and mucoadhesion , .Were made to keep the surface pH as close to buccal/salivary pH as possible, by the proper selection of the polymers for developing the buccal films.PH of all the films was within the range of salivary pH.Difference was found in surface pH of different films.Required for a mucoadhesive polymer to expand and create a proper macromolecular mesh of sufficient size, and also to induce mobility in the polymer chains in order to enhance the interpenetration process between polymer and mucin.Swelling permits a mechanical entanglement by exposing the bioadhesive sites for hydrogen bonding and/or electrostatic interaction between the polymer and the mucous network .A critical degree of hydration of the mucoadhesive polymer exists where optimum swelling and bioadhesion occurs .Effect of glipizide on the swelling behaviour and the residence time of various mucoadhesive polymers, was also observed .Medicated films showed high swelling index inparison to plain films.Addition of the water-insoluble drug increased the water uptake of the film.Is possibly due to micronized drug particles which exist between the polymer chains allowing each chain to hydrate freely, resulting in weak hydrogen bonding areas around the glipizide molecules.Areas may increase the strength of the swollen layer followed by an obvious increase in the amount of penetrated water .A practically water-insoluble drug, was found to increase the swelling behaviour of HPMC matrices , while lower swelling indices were observed when the same drug was added to Gantrez-169pressed matrix .Influence of drug on the swelling properties of polymer matrices is primarily dependent on the substituted groups of the polymer.Hydroxyl group in the molecules plays an important role in the matrix integrity of the swollen hydrophilic cellulose matrices.Amount and properties of the incorporated drug determine matrix integrity.For various formulations was in order of F2 > F1 > F4 > F3.Percentage swelling of HPMC-E15 films was reduced by the addition of Carbopol 934P and Eudragit-RL100 and increased by the addition of SCMC.Containing films showed higher percent swelling due to presence of more hydroxyl group in the SCMC molecules.Hydrophilic additive dissolves rapidly resulting in high porosity.Void volume is thus expected to be occupied by the external solvent diffusing into the film and thereby accelerating the dissolution of the gel .Of the drug induced significant reduction of the residence time of various formulations.Enhanced erosion rate was observed with the non-ionic polymers (HPMC with Eudragit RL100).The particle swells, the matrix experiences intra-matrix swelling force which promotes disintegration and leaching of the drug leaving behind a highly porous matrix.Influx weakens the network integrity of the polymer, thus influencing structural resistance of the swollen matrices, which in turn results in pronounced erosion of the lose gel layer .Water-soluble hydrophilic polymers like SCMC dissolve rapidly and introduce porosity.Void volume is thus expected to be occupied by the external solvent which diffuses into the film and thereby accelerate the dissolution of the gel .In vitro_ residence time of the film was in the order of F4 > F2 > F1 > F3.Folding endurance was measured manually, by folding the film repeatedly at a point till they broke.Breaking time was considered as the end point.Was found to be highest for F4 (290±4.Lowest for F1 (164.It was found that folding endurance of HPMC films was increased by the addition of polymers in the order; Eudragit-RL100 SCMC > Carbopol 934P.Folding endurance values of the films were found to be optimum and therefore the films exhibited good physical and mechanical properties.In formulations was uniform with a range of 4.Mg/20 mm diameter of the film (F1) to 4.Mg/20 mm diameter of the film (F3).This basis, it was found that the drug was dispersed uniformly throughout the film.Vitro_ release studies of various formulations were performed using pH 6.Buffer as dissolution medium and measuring drug concentration spectrophotometrically at 274 nm.Difference was observed in the release of glipizide films containing eudragit, carbopol and SCMC in the graph plotted between the cumulative per cent drug released from the formulations and the time .Carbopol polymers exhibited high swelling, the film weight of these polymers was noted to be increased to the extent of 25 to 60% from the initial weight within 2 h .The marked increase in surface area during swelling can promote drug release but the increase in diffusion path length of the drug may paradoxically delay the release.Addition, the thick gel layer formed on the swollen film surface is capable of preventing matrix disintegration and controlling additional water penetration .Films showed high dissolution rate aspared to Eudragit RL100 films.Was found that the drug release from the films varied with respect to the proportion of polymers.Studies done with the groups of formulations, from which these four formulations were selected, showed that increase in the polymer concentration reduced the diffusion of drug from the matrix.Formulations, formulation F2 showed the good release pattern aspared to others.Drug release whether diffusion, swelling or erosion was confirmed by Higuchi's plots.Shows the graphical representation of cumulative percentage drug release versus square root of time.Higuchi's Plots were found to be linear with correlation coefficient values of 0.0.0.F1, F2, F3 and F4, respectively.Was concluded that the release of drug from the films followed the diffusion controlled mechanism in all the formulations.Also concluded that formulation F1 (containing HPMC alone) and F2 (containing HPMC with SCMC) showed good swelling, a convenient residence time as well as promising drug release pattern.Basis of release pattern, swelling and residence time, F1 and F2 formulations were selected for _ ex vivo_ study._ ex vivo_ study, drug permeation through the porcine buccal mucosa was determined for formulation F1 and F2 .Drug permeation was found to be 78.In F1 and F2 after 10 h.Study indicates a good potential of erodible mucoadhesive buccal films containing glipizide for systemic delivery with an added advantage of circumventing the hepatic first pass metabolism.Results of the study show that therapeutic levels of glipizide can be delivered buccally.May be concluded that the films containing 5 mg glipizide in 4.HPMC with 1.SCMC (F2), show good swelling, a convenient residence time and promising controlled drug release, thus seems to be a potential candidate for the development of buccal film for effective therapeutic use.In vivo_ studies need to be designed and executed to substantiate further _ in vitro - in vivo_ correlation.References Ishida M, Nambu N, Nagai T.Mucosal dosage form of insulin.Bull 1982;30:980.Collins AE, Deasy PB, MacCarthy DJ, Shanley DB.Of a controlled releasepact containing tetracycline hydrochloride bonded to tooth for the treatment of periodontal disease.J Pharm 1989;51:103.Elkayam R, Friedman M, Stabholz A, Soskolne AW, Sela MN, Golub L.Containing minocycline for local treatment of periodontal disease.Control Release 1988;7:231.Samaranayake L, Ferguson M.Of antifungal agents to the oral cavity.Drug Del Rev 1994;13:161.Nagai T.Topical drug delivery system.Control Release 1985;2:121.Nagai T, Machida Y.Adhesive dosage forms.Int 1985;196.Smart JD.Basics and underlying mechanisms of mucoadhesion.Drug Deliv Rev 2005;57:1556-68.Jasti B, Li X, Cleary G.Advances in mucoadhesive drug delivery systems.Briefing Pharma Tech 2003;194-6.Salamat-Miller N, Chittchang M, Johnston TP.Use of mucoadhesive polymers in buccal drug delivery.Drug Deliv Rev 2005;57:1666-91.Semalty A, Semalty M.Polymers: A review.From: http://www..Ali J, Kha, RK, Ahuja A.And characterization of a buccoadhesive erodible tablet for the treatment of oral lesions. Kohda Y, Kobayashi H, Baba Y, Yuasa H, Ozeki T, Kanaya Y, et al_ .Of lidocaine hydrochloride from buccal mucosa-adhesive films with solid dispersion.J Pharm 1997;158:147-55.Nair MK, Chien YW.Of anticandidal delivery systems: (II) Mucoadhesive devices for prolonged drug delivery in the oral cavity.Dev Ind Pharm 1996;22:243-53.Perioli L, Ambrogi V, Rubini D, Giovagnoli S, Ricci M, Blasi P, et al_ .Buccal formulation containing metronidazole for the treatment of periodontal disease.Control Release 2004;95:521-33.B, Russo E, Caviglioli G, Cafaggi S, Bignardi G, Development and characterization of a buccoadhesive dosage form of oxycodone hydrochloride.Dev Ind Pharm 1996;22:445-50.Ali J, Kha, RK, Ahuja A, Kalra R.Erodible disk for treatment of oro-dental infections: Design and characterization.J Pharm 2002;238:93-103.R, Kavimani S, Mullaicharam AR, Jayakar B.Vitro studies on buccal strips of glibenclamide using chitosan.J Pharm Sci 1997;59:232-5.Bremecker KD, Strempel H, Klein G.Concept for a mucosal adhesive ointment.Pharm Sci 1984;73:548-52.Shin SC, Bum JP, Choi JS.Bioavailability by buccal administration of triamcinolone acetonide from the bioadhesive gels in rabbits.J Pharm 2000;209:37-43.Nafee NA, Ismail FA, Boraie NA, Mortada LM, Mucoadhesive buccal patches of miconazole nitrate:in vitro/in vivo performance and effect of ageing.J Pharm 2003;264:1-14.Foster RH, Plosker GL.A review of the pharmacoeconomic implications of the extended-release formulation in type 2 diabetes mellitus.2000;18:289-306.Devi K, Paranjothy KL.And evaluation of free film and transdermal patches of ketorolac tromethamine using polymers and pressure sensitive adhesives.Pharma 1998;485:97.Semalty A, Bhojwani M, Bhatt GK, Gupta GD, Shrivastav AK.And evaluation of mucoadhesive buccal films of diltiazem hydrochloride.J Pharm Sci 2005;67:548-52.HE, Hoogstraate JA, Verhoef JC.Advances in buccal drug delivery and absorption in vitro_ and _ in vivo_ studies.Release 1999;62:149-59.Chng HS, Park H, Kelly P, Robinson JR.Polymers as platforms for oral controlled drug delivery: II, Synthesis and evaluation of some swelling, water-insoluble bioadhesive polymers.Pharm Sci 1985;74:399-405.Park H, Robinson JR.Properties of water insoluble polymers important to mucin epithelial adhesion.Control Release 1985;2:47-57.JM, Robinson JR, Leung SH.Of acrylic polymers to mucin/ epithelial surfaces: Structure-property relationships.Rev Ther Drug Carr Syst 1998;5:21-67.Peppas NA, Buri PA.Interfacial and molecular aspects of polymer bioadhesion on soft tissues.Control Release 1985;2:257-75.Panomsuk SP, Hatanaka T, Aiba T, Katayama K, Koizumi T.Study of the hydrophilic cellulose matrix: Effect of drugs on the swelling properties.Pharm Bull 1996;44:1039-42.KA, Effect of physicochemical properties of the hydrophilic Gantrez matrix.J Pharm Sci 2001;15:35-40.Samuelov Y, Donbrow M, Friedman M.Release of drugs from ethyl cellulose-polyethylene glycol films and kinetics of drug release.Sci 1979;68:325-9.Korsmeyer RW, Gurny R, Doelker E, Buri P, Peppas NA.Of solute release from porous hydrophilic polymers.J Pharm 1983;15:25.Rodriguez CF, Bruneau N, Barra J, Alfonso D, Doelker E.Cellulose derivatives as drug delivery carriers: Influence of the substitution type on the properties ofpressed matrix tablets.In_ : Wise DL, editors.Pharmaceutical Controlled Release Technology.1.
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воскресенье, 20 апреля 2008 г.

Aacr: colon cancer prevention continues after stopping celecoxib (celebrex)

The 2nd option under 'Security' in the tree (Allow active content to run in files on myputer.Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage Meeting Coverage > > Medical News from AACR: American Association for Cancer Research Meeting AACR: COLON CANCER PREVENTION CONTINUES AFTER STOPPING CELECOXIB (CELEBREX) By Charles Bankhead, Staff Writer, MedPage Today Published: April 18, 2008 Reviewed by ; Emeritus Professor University of Pennsylvania School of Medicine.Earn CME/CE credit for reading medical news Use this code to embed video on your website or blog: Explain to interested patients that this study found that the Cox-2 inhibitor celecoxib has effects that seem to protect against colon cancer even after discontinuation of treatment.That celecoxib has cardiovascular side effects and should be used for cancer prevention only after careful discussion with a physician.These findings were reported at a conference as a published abstract and should be considered preliminary until they appear in a peer-reviewed journal."There has been a significant amount of negative press about Cox-2 inhibitors, including celecoxib, and clearly these drugs are risky for some patients," said Dr."However, our study also shows that for patients without major cardiovascular risk factors, celecoxib at low doses protects against high-risk lesions that can lead to colon cancer.The findings came from extended follow-up of patients in the Adenoma Prevention with Celecoxib (APC) trial.Study, which was halted after three years when cardiovascular risks of celecoxib came to light, involved 2,035 adults with a history of multiple or large colorectal adenomas.Participants had been randomized to placebo or to celecoxib at 200 mg or 400 mg twice daily.Colonoscopy was performed at baseline and after one and three years of follow-up.Objective was prevention of sporadic adenomas at the end of the trial.The primary analysis showed that low-dose celecoxib reduced the overall incidence of adenomas by 33% and the occurrence of advanced adenomas by 57%pared with placebo.Celecoxib reduced overall adenoma incidence by 45% and advanced lesions by 66%.Study participants were offered the opportunity to remain in the trial for an additional two years of follow-up off treatment.
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суббота, 19 апреля 2008 г.

Halflytely and bisacodyl(polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride and bisacodyl) kitfor use [braintree laboratories, inc.]

AND BISACODYL (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL) KIT FOR USE INITIAL U.APPROVAL: 2004 RECENT MAJOR CHANGES Dosage and Administration 9/2007 INDICATIONS AND USAGE HalfLytely and Bisacodyl Tablets Bowel Prep Kit is a gastrointestinal lavage indicated for cleansing of the colon as a preparation for colonoscopy in adults () DOSAGE AND ADMINISTRATION Take two 5 mg bisacodyl delayed release tablets with water.NOT chew or crush the tablets.Prepare the HalfLytely solution by filling the container to the 2 liter mark with water.The container.To dissolve the powder.This preparation can be used without the addition of a Flavor Pack.For a bowel movement (or maximum of 6 hours) then drink the 2 liter HalfLytely solution at a rate of 8 ounces every 10 minutes.Of the solution.DOSAGE FORMS AND STRENGTHS Two 5 mg bisacodyl delayed release tablets () One 2 liter HalfLytely bottle with powder for reconstitution () CONTRAINDICATIONS Patients known to be allergic to polyethylene glycol () Gastrointestinal (GI) obstruction () Bowel perforation () Toxic colitis () Toxic megacolon () WARNINGS AND PRECAUTIONS Neurologic () Gastrointestinal () Renal Insufficiency () Allergic Reaction () ADVERSE REACTIONS Mostmon adverse reactions (< 3%) are abdominal pain/cramping, nausea, vomiting and headache () To report SUSPECTED ADVERSE REACTIONS, contact Braintree Laboratories, Inc.1-800-874-6756 or FDA at 1-800-FDA-1088 or DRUG INTERACTIONS Oral medication administered within one hour of the start of administration of HalfLytely solution may be flushed from the GI tract and the medication may not be absorbed.Do not take the bisacodyl delayed release tablets within one hour of taking an antacid.See for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling REVISED: 10/2007 FULL PRESCRIBING INFORMATION: CONTENTS Sections or subsections omitted from the full prescribing information are not listed 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 3 DOSAGE FORMS AND STRENGTHS 4 CONTRAINDICATIONS 5 WARNINGS AND PRECAUTIONS 5.5.5.INSUFFICIENCY 5.6 ADVERSE REACTIONS 6.STUDIES EXPERIENCE 6.EXPERIENCE 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8.8.MOTHERS 8.USE 8.11 DESCRIPTION 12 CLINICAL PHARMACOLOGY 12.OF ACTION 12.12.13 NONCLINICAL TOXICOLOGY 13.MUTAGENESIS, IMPAIRMENT OF FERTILITY 14 CLINICAL STUDIES 16 HOW SUPPLIED/STORAGE AND HANDLING 17 PATIENT COUNSELING INFORMATION 17.PATIENT LABELING FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE HalfLytely and Bisacodyl Tablets Bowel Prep Kit is indicated for cleansing of the colon as a preparation for colonoscopy in adults.2 DOSAGE AND ADMINISTRATION The rmended HalfLytely and Bisacodyl Tablets Bowel Prep Kit oral dosage regimen for adults on the day prior to colonoscopy is as follows: Take two 5 mg bisacodyl delayed release tablets with water.NOT chew or crush the tablets.Add flavor pack of choice (if applicable) to the 2 liter container.Additional ingredients (other than flavor packs provided) should be added to the solution.Prepare the HalfLytely solution by filling the container to the 2 liter mark with water.Container.To dissolve the powder.Wait for a bowel movement (or maximum of 6 hours) then drink the 2 liter HalfLytely solution at a rate of 8 ounces every 10 minutes.Of the solution.DOSAGE FORMS AND STRENGTHS Two pink, round, enteric coated 5 mg bisacodyl delayed release tablets, stamped "BRA" One 2 liter HalfLytely bottle with powder for reconstitution 4 CONTRAINDICATIONS The HalfLytely and Bisacodyl Tablets Bowel Prep Kit is contraindicated in the following conditions: Known allergies to polyethylene glycol or otherponents of the kit Gastrointestinal (GI) obstruction Bowel perforation Toxic colitis Toxic megacolon 5 WARNINGS AND PRECAUTIONS 5.There have been reports of generalized tonic-clonic seizures in patients with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures.Cases were associated with severe vomiting, excessive beverage consumption and electrolyte abnormalities (for example, hyponatremia, hypokalemia).Neurologic abnormalities resolved with correction of fluid and electrolyte abnormalities.HalfLytely and Bisacodyl Tablets Bowel Prep Kit should be used with caution in patients using coitant medications (such as diuretics) that increase the risk of electrolyte abnormalities or patients with known or suspected hyponatremia.Baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in these patients.5.Use with caution in patient with severe ulcerative colitis, ileus or gastric retention.Patients with impaired gag reflex and patients prone to regurgitation or aspiration during administration of HalfLytely solution.GI obstruction or perforation is suspected, appropriate studies should be performed to rule out these conditions before administration.Been reports of ischemic colitis in patients with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit.Patients develop severe abdominal pain or rectal bleeding, patients should be evaluated as soon as possible.5.INSUFFICIENCY Patients with impaired water handling who experience severe vomiting should be closely monitored including measurement of electrolytes (sodium, potassium, calcium, BUN and creatinine).5.REACTION Hives and skin rashes have been reported with PEG-3350 based products which are suggestive of an allergic reaction.6 ADVERSE REACTIONS 6.EXPERIENCE Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directlypared to rates in clinical studies of another drug and may not reflect the rates observed in practice.In a clinical study of HalfLytely and (10 mg vs.Mg) Bisacodyl Tablets Bowel Prep Kit multicentered, controlled clinical trials, abdominal pain/cramping, nausea, vomiting and headache were the mostmon adverse reactions (< 3%) after the administration of HalfLytely and (10 mg or 20 mg) Bisacodyl Tablets Bowel Prep Kit.Than 1% of patients exposed to HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit reported vomiting and abdominal pain/cramping.The data in reflects exposure in 222 patients to HalfLytely and 10 mg bisacodyl tablets vs.Patients exposed to HalfLytely and 20 mg bisacodyl tablets.And 10 mg Bisacodyl Tablets Bowel Prep Kit population was 20-85 years of age, 46% male, 54% female, 10% African American, 85% Caucasian, 8% Hispanic requiring a colonoscopy.Of theparator group were similar.Table 1: Adverse Reactions Observed in at Least 1% of Patients HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit (N=222)HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit (N=223) Abdominal pain/cramping 1% 2% Nausea 1% 2% Vomiting 1% 2% Headache 2% 1% displays patient diary ratings of their symptoms associated with HalfLytely and Bisacodyl Tablets Bowel Prep Kits (10 mg bisacodyl vs.Bisacodyl tablets) in the controlled trial.Table 2: Percentage of Patients Reporting in their Diaries "bothersome" to "severely distressing" Symptoms in Controlled Clinical HalfLytely and Bisacodyl Tablets Bowel Prep Kit Trial1 1 Patients were specifically asked about the occurrence of the following symptoms: nausea, abdominal cramping, fullness, vomiting, and overall difort.Half Lytely and 10 mg Bisacodyl Tablets Bowel Prep Kit (N=222)HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit (N=223) Nausea 13% 21% Abdominal cramping 7% 14% Abdominal fullness 11% 13% Vomiting 5% 8% Overall Difort 14% 20% 6.EXPERIENCE The following adverse reactions have been identified during postapproval use of HalfLytely and Bisacodyl Tablets Bowel Prep Kit.Reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.Allergic Reactions: Cases of urticaria, rhinorrhea, dermatitis and anaphylactic reactions have been reported with PEG-based products which may represent allergic reactions.Gastrointestinal: There are isolated reports of serious post-marketing events following the administration of PEG-based products in patients over 60 years of age.Adverse reactions include upper GI bleeding from a Mallory-Weiss tear, esophageal perforation, asystole, and acute pulmonary edema after vomiting and aspirating the PEG-based solution.During administration of 4 liters of PEG-3350 colon cleansing preparation the following serious adverse reactions were seen: two deaths in end stage renal failure patients who developed diarrhea, vomiting and dysnatremia.Ischemic colitis has been reported with use of HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit for colon preparation prior to colonoscopy.A causal relationship between these ischemic colitis cases and the use of HalfLytely and Bisacodyl Tablets Bowel Prep Kit has not been established.Neurologic: There have been reports of generalized tonic-clonic seizures associated with use of large volume (4 liter) PEG-based colon preparation products in patients with no prior history of seizures.Dizziness and syncope have been reported .7 DRUG INTERACTIONS Oral medication administered within one hour of the start of administration of HalfLytely solution may be flushed from the GI tract and the medication may not be absorbed.Do not take the bisacodyl delayed release tablets within one hour of taking an antacid.USE IN SPECIFIC POPULATIONS 8.Pregnancy Category C.Reproduction studies have not been conducted.Is not known whether HalfLytely and Bisacodyl Tablets Bowel Prep Kit can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.And Bisacodyl Tablets Bowel Prep Kit should be given to a pregnant or nursing woman only if clearly needed.NURSING MOTHERS It is not known whether this drug is excreted in human milk.Many drugs are excreted in human milk, caution should be exercised when HalfLytely and Bisacodyl Tablets Bowel Prep Kit is administered to a nursing woman.8.USE Safety and effectiveness in pediatric patients has not been established.GERIATRIC USE Of the 222 patients who received HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit in clinical trials, 73 (33%) were 65 years of age or older, while 18 (8%) were 75 years of age or older.Differences in safety or effectiveness were observed between geriatric patients and younger patients, and other reported clinical experience has not identified differences in responses between geriatric patients and younger patients but greater sensitivity of some older individuals cannot be ruled out.11 DESCRIPTION Each HalfLytely and Bisacodyl Tablets Bowel Prep Kit consists of one 2 liter bottle of HalfLytely (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution and two 5 mg bisacodyl, delayed release tablets.Delayed release tablets: Each pink, round, enteric coated bisacodyl delayed release tablet (stamped "BRA") contains 5 mg of bisacodyl, USP (C22H19NO4) with a molecular weight of 361.Inactive ingredients include lactose (anhydrous) NF, microcrystalline cellulose NF, croscarmellose sodium NF, magnesium stearate NF, Eudragit L 30-55, polyethylene glycol 400, talc USP, gelatin, calcium sulfate (anhydrous) NF, confectioners sugar, kaolin USP, sucrose NF, Opalux pink, beeswax, and carnauba wax.Bisacodyl delayed release tablets are administered orally prior to drinking the HalfLytely solution .(PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution): A white powder for reconstitution containing 210 grams of PEG-3350, 2.Of sodium bicarbonate, 5.Of sodium chloride, 0.Of potassium chloride and 1 gram of flavoring ingredient (if applicable).Packs are available in Cherry, Lemon-Lime and Orange.Preparation can be used without the addition of a Flavor Pack.Dissolved in water to a volume of 2 liters, the HalfLytely solution is isosmotic, clear, and colorless.HalfLytely solution is administered orally after taking the two bisacodyl delayed release tablets .CLINICAL PHARMACOLOGY 12.OF ACTION HalfLytely and Bisacodyl Tablets Bowel Prep Kit induces diarrhea which cleanses the colon.12.A stimulant laxative, is hydrolyzed by intestinal brush border enzymes and colonic bacteria to form an active metabolite that acts directly on the colonic mucosa to produce colonic peristalsis.PHARMACOKINETICS The osmotic activity of HalfLytely solution results in no net absorption or excretion of ions or water.13 NONCLINICAL TOXICOLOGY 13.MUTAGENESIS, IMPAIRMENT OF FERTILITY Long-term studies in animals have not been performed to evaluate the carcinogenic potential of HalfLytely and Bisacodyl Tablets Bowel Prep Kit.To evaluate its potential for impairment of fertility or its mutagenic potential have not been performed.14 CLINICAL STUDIES The colon cleansing efficacy of HalfLytely and Bisacodyl Tablets Bowel Prep Kit (with 10 mg of bisacodyl) was evaluated in a randomized, single blind, active-controlled, multicenter study.This study, 444 adult patients were included in the efficacy analysis.In age from 19 to 86 years old (mean age 57 years old) with 53% female and 47% male patients.Was distributed as follows: 86% Caucasian, 9% African American, 7% Hispanic or Latino, and 3% other.Patients were randomized to one of the following two colon preparations: 1) HalfLytely and Bisacodyl Tablets Bowel Prep Kit at a rate of 8 ounces every 10 minutes.Patients were instructed to refrain from solid food and to have clear liquids on the day before colonoscopy.Addition, patients were instructed to consume nothing by mouth, except clear liquids, from the time the preparation waspleted until midnight.Were instructed not to eat or drink anything from midnight until after the colonoscopy waspleted.The primary efficacy endpoint was the proportion of patients with successful colon cleansing (assessed by the colonoscopists), see below.Table 3: Colon Cleansing Efficacy 1 Responders were patients whose colon preparations were graded excellent (no more than small bits of adherent feces/fluid) or good (small amounts of feces or fluid not interfering with the exam) by the colonoscopist; 2 Non-responders were patients whose colon preparations were graded fair (enough feces or fluid to prevent apletely reliable exam) or poor (large amounts of fecal residue requiring additional cleansing) by the colonoscopists or patients who were unable to tolerate their colon preparation.The HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit does not provide any additional efficacy benefits over the HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit.Treatment Group Responders1 n/N(%)Non-responders2 n/N(%) HalfLytely and 20 mg Bisacodyl Tablets Bowel Prep Kit (N=223) 196/223 (88) 27/223 (12) HalfLytely and 10 mg Bisacodyl Tablets Bowel Prep Kit (N=221) 192/221 (87) 29/221 (13) 16 HOW SUPPLIED/STORAGE AND HANDLING Each HalfLytely and Bisacodyl Tablets Bowel Prep Kit contains: One pack of bisacodyl delayed release tablets containing two pink, round, enteric coated 5 mg bisacodyl delayed release tablets, stamped "BRA" One 2 liter bottle of HalfLytely (PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride for oral solution) powder for reconstitution containing 210 grams of polyethylene glycol (PEG) 3350, 2.Of sodium bicarbonate, 5.Of sodium chloride, 0.Potassium chloride, and 1 gram of flavoring ingredient (if applicable).2 liters of water, the reconstituted HalfLytely solution (clear and colorless) contains 31.Of PEG-3350, 65 mmol/L of sodium, 53 mmol/L of chloride, 17 mmol/L of bicarbonate and 5 mmol/L of potassium.Lemon-Lime HalfLytely and Bisacodyl Tablets Bowel Prep Kit contains 1 gram lemon-lime flavoring ingredient.And Bisacodyl Tablets Bowel Prep Kit with Flavor Packs contains 3 packs (1 gram each Cherry, Lemon-Lime and Orange flavors).Storage: Store at 20-25C (68-77F).Permitted between 15-30C (59-86F).HalfLytely solution, which may be refrigerated, should be used within 48 hours.Lemon-Lime HalfLytely and Bisacodyl Tablets Bowel Prep Kit NDC 52268-522-01 HalfLytely and Bisacodyl Tablets Bowel Prep Kit with Flavor Packs NDC 52268-521-01 17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling If a patient experiences severe bloating, distention or abdominal pain, administration of the solution should be slowed or temporarily discontinued until the symptoms abate.Should be advised to report these events to their physician.Hives and skin rashes have been reported that are suggestive of an allergic reaction.Should be advised to report to their physician any allergic reaction.Should be discontinued.Instruct patients NOT to drink large quantities of clear liquids Consider performing baseline and post-colonoscopy laboratory tests (sodium, potassium, calcium, creatinine, and BUN) in patients with impaired water handling (renal insufficiency, taking diuretics) .Patients that oral medication administered within one hour of the start of administration of HalfLytely solution may be flushed from the GI tract and the medication may not be absorbed.FDA-APPROVED PATIENT LABELING HalfLytely and Bisacodyl Tablets Bowel Prep Kit produces a watery stool which cleanses the colon.No solid food or milk (clear liquids only) should be consumed on the day of the preparation.Take two 5 mg bisacodyl delayed release tablets with water (do NOT chew or crush tablets).Prepare the HalfLytely solution according to the instructions on the kit.No additional ingredients (other than flavor packs provided) should be added to the solution.You have a bowel movement, or waiting a maximum of six hours, drink ALL of the HalfLytely solution.Drink the 2 liter HalfLytely solution at a rate of 8 ounces every 10 minutes.Drinking of each portion is better than drinking small amounts continuously.No antacids should be taken within one hour of taking the bisacodyl delayed release tablets.Do not drink large quantities of clear liquids after taking the HalfLytely solution until your colonoscopy.First bowel movement should occur approximately 1-6 hours after taking the two bisacodyl delayed release tablets.Abdominal bloating or distention may occur before the first bowel movement.Your abdominal distention or difort continues stop drinking the HalfLytely solution temporarily or drink each portion at longer intervals until your symptoms disappear.Braintree Laboratories, Inc.MA 02185 HalfLytely and Bisacodyl (polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride and bisacodyl) PRODUCT INFO Product Code 52268-522 Dosage Form KIT PACKAGING # NDC Package Description Multilevel Packaging 1 52268-522-01 1 KIT In 1 CARTON None QUANTITY OF PARTS Part # Package Quantity Total Product Quantity PART 1 1 BLISTER PACK 2 TABLET In 1 PART 2 1 BOTTLE, PLASTIC 2 LITER In 1 Part 1 of 2 Bisacodyl (Bisacodyl) Route Of Administration ORAL Dosage Form TABLET, DELAYED RELEASE DEA Schedule INGREDIENTS Name (Active Moiety) Type Strength BISACODYL (bisacodyl) Active 5 MILLIGRAM In 1 TABLET LACTOSE Inactive MICROCRYSTALLINE CELLULOSE Inactive CROSCARMELLOSE SODIUM Inactive MAGNESIUM STEARATE Inactive EUDRAGIT L 30-55 Inactive POLYETHYLENE GLYCOL 400 Inactive TALC Inactive GELATIN Inactive CALCIUM SULFATE Inactive CONFECTIONS SUGAR Inactive KAOLIN Inactive SUCROSE Inactive OPALUX PINK Inactive BEESWAX Inactive CARNUBA WAX Inactive IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color pink (Pink) Score 1 Shape ROUND (ROUND) Symbol false Imprint Code BRA Coating true Size 5mm PACKAGING # NDC Package Description Multilevel Packaging 1 52268-504-02 2 TABLET In 1 BLISTER PACK None Part 2 of 2 HalfLytely (polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride) Route Of Administration ORAL Dosage Form POWDER, FOR SOLUTION DEA Schedule INGREDIENTS Name (Active Moiety) Type Strength POLYETHYLENE GLYCOL 3350 (polyethylene glycol 3350) Active 210 GRAM In 2 LITER SODIUM BICARBONATE (sodium bicarbonate) Active 2.In 2 LITER SODIUM CHLORIDE (sodium chloride) Active 5.In 2 LITER POTASSIUM CHLORIDE (potassium chloride) Active 0.In 2 LITER FLAVOR INGREDIENT Inactive 1.In 2 LITER IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color Score Shape Symbol Imprint Code Coating Size PACKAGING # NDC Package Description Multilevel Packaging 1 2 LITER In 1 BOTTLE, PLASTIC None HalfLytely and Bisacodyl (polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride and bisacodyl) PRODUCT INFO Product Code 52268-521 Dosage Form KIT PACKAGING # NDC Package Description Multilevel Packaging 1 52268-521-01 1 KIT In 1 CARTON None QUANTITY OF PARTS Part # Package Quantity Total Product Quantity PART 1 1 BLISTER PACK 2 TABLET In 1 PART 2 1 BOTTLE, PLASTIC 2 LITER In 1 Part 1 of 2 Bisacodyl (Bisacodyl) Route Of Administration ORAL Dosage Form TABLET, DELAYED RELEASE DEA Schedule INGREDIENTS Name (Active Moiety) Type Strength BISACODYL (bisacodyl) Active 5 MILLIGRAM In 1 TABLET LACTOSE Inactive MICROCRYSTALLINE CELLULOSE Inactive CROSCARMELLOSE SODIUM Inactive MAGNESIUM STEARATE Inactive EUDRAGIT L 30-55 Inactive POLYETHYLENE GLYCOL 400 Inactive TALC Inactive GELATIN Inactive CALCIUM SULFATE Inactive CONFECTIONS SUGAR Inactive KAOLIN Inactive SUCROSE Inactive OPALUX PINK Inactive BEESWAX Inactive CARNUBA WAX Inactive IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color pink (Pink) Score 1 Shape ROUND (ROUND) Symbol false Imprint Code BRA Coating true Size 5mm PACKAGING # NDC Package Description Multilevel Packaging 1 52268-504-02 2 TABLET In 1 BLISTER PACK None Part 2 of 2 HalfLytely (polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride) Route Of Administration ORAL Dosage Form POWDER, FOR SOLUTION DEA Schedule INGREDIENTS Name (Active Moiety) Type Strength POLYETHYLENE GLYCOL 3350 (polyethylene glycol 3350) Active 210 GRAM In 2 LITER SODIUM BICARBONATE (sodium bicarbonate) Active 2.In 2 LITER SODIUM CHLORIDE (sodium chloride) Active 5.In 2 LITER POTASSIUM CHLORIDE (potassium chloride) Active 0.In 2 LITER CHERRY FLAVOR Inactive 1.In 2 LITER LEMON-LIME FLAVOR Inactive 1.
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пятница, 18 апреля 2008 г.

Nearly 1 in 5 troops has mental problems after war service (AP)

Only News Photos Video/Audio NEARLY 1 IN 5 TROOPS HAS MENTAL PROBLEMS AFTER WAR SERVICE By PAULINE JELINEK, Associated Press Writer _ 37 minutes ago_ WASHINGTON - Roughly one in every five U.Troops who have survived the bombs and other dangers of Iraq and Afghanistan now suffers from major depression or post-traumatic stress, an independent study said Thursday.Estimated the toll at 300,000 or more.As many or more report possible brain injuries from explosions or other head wounds, said the study, the first major survey from outside the government.Only about half of those with mental health problems have sought treatment.Fewer of those with head injuries have seen doctors.Army Surgeon General Eric Schoomaker said the report, from the Rand Corp.Wee."They're helping us to raise the visibility and the attention that's needed by the American public at large," said Schoomaker, a lieutenant general.Are making this a national debate.The researchers said 18.Of current and former service members contacted in a recent survey reported symptoms of depression or post-traumatic stress.On Pentagon data that more than 1.To the two wars, the researchers calculated that about 300,000 are suffering mental health problems.Nineteen percent or an estimated 320,000 may have suffered head injuries, the study calculated.Range from mild concussions to severe, penetrating head wounds."There is a major health crisis facing those men and women who have served our nation in Iraq and Afghanistan," said Terri Tanielian, the project's co-leader and a researcher at Rand.Receive appropriate and effective care for these mental health conditions, there will be long-term consequences for them and for the nation.The study, the first large-scale, private assessment of its kind, includes a survey of 1,965 service members across the country, from all branches of the armed forces and including those still in the military as well veterans who havepleted their service.Iraq war has been notable for the repeat tours required of many troops, sometimes for longer than a year at a time.The results of the study appear consistent with mental health reports from within the government, though the Defense Department has not released the number of people it has diagnosed or who are being treated for mental problems.The Department of Veterans Affairs said this month that its records show about 120,000 who served in the two wars and are no longer in the military have been diagnosed with mental health problems.Those, about 60,000 are suffering from post-traumatic stress, and depression runs a close second.Veterans Affairs is responsible for care of service members after they have leave the military.Defense Department covers active duty and reservist needs.The lack of numbers from the Pentagon was one motivation for the Rand study, Tanielian said in an interview.The most prominent and detailed Pentagon study on the military's mental health that is released regularly to the public is the Army's survey of soldiers, taken annually at the battle zones since 2003.The most recent one, last fall, found 18.Of Army soldiers suffered mental health problems such as depression, anxiety or acute stress in 2007,pared with 20.The previous year.Other studies have variously estimated that 10 percent to 20 percent of troops had symptoms of mental health problems.Col.Sutton, who heads a new Pentagon center on brain injury, said the Rand study will add to the work defense officials are doing.Researching best practices used inside the military and out, improving and expanding training and prevention programs, adding mental health staff and trying to change a military culture in which many troops are afraid or embarrassed to get mental health treatment."We've got to get the word out that seeking help is a sign of strength," Sutton said.She said officials have been working to add thousands more mental health professionals to help the uniformed psychiatrists, psychologists and others struggling to meet the wartime demands of troops and their families.The services, officials are trying to hire over 1,000 additional staff.Health care by contract to the Pentagon have added over 3,000 in the past year, and the U.Public Health Service has provided some 200, she said.Has added some 3,800 professionals in the past couple of years, officials there said.In other survey results: _About 7 percent of those polled reported both a probable brain injury and current post-traumatic stress or major depression._Rates of post-traumatic stress and major depression were highest among women and reservists._About 53 percent of service members with post-traumatic stress or depression sought help over the past year, and 43 percent reported being evaluated by a physician for their head injuries at some time._They gave various reasons for not getting help, including that they worried about the side effects of medication, they believed family and friends could help them with the problem, or they feared seeking care might damage their careers.The Army's own warfront survey found the stigma associated with getting help has been decreasing slowly but steadily in recent years.Report was titled "Invisible Wounds of War: Psychological and Cognitive Injuries, Their Consequences, and Services to Assist Recovery.Was sponsored by a grant from the Californiamunity Foundation and done by researchers from Rand Health and the Rand National Security Research Division.Division also has done work under contracts with the Pentagon and other defense agencies as well as allied foreign governments and foundations.___ On the Net: Rand Corporation: Army studies: Yahoo!RMEND THIS STORY Rmend It: Not at All Somewhat Moderately Highly Very Highly Average (Not Rated) _AP_ _AP_ _AP_ _AP_ _Politico_ _AP_ _AP_ _AP_ _AP_ _AP_ _ Reuters - 34 minutes ago_ _ AP - 47 minutes ago_ _ AP - 1 hour, 2 minutes ago_ _ WRAL Raleigh - 1 hour, 3 minutes ago_ Sponsored Links ( ) $150,000 Mortgage for $483/month.To 4 free quotes.Mortgage Rates Hit 26 Month Lows.Your New Mortgage Payment. $300,000 Mortgage for only $965/month.$1,000's - No obligation. Related Video U.Troops search for Taliban forces during a patrol in Afghanistans Shamal district of Khost. Elsewhere On The Web POLITICO: ABC NEWS: MCCLATCHY NEWSPAPERS: Republicans shed 'underdog' status in White House race.Add Headlines To Your Personalized My Yahoo!White House News - AP NEWS ALERTS __ Get an alert when there are new stories about: post-traumatic stress mental health staff Army Surgeon General Californiamunity Foundation National Security Research Division - - SEARCH: All News Yahoo!Only News Photos Video/Audio PRIMARY NAVIGATION Copyright 2008 The Associated Press.
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четверг, 17 апреля 2008 г.

Intensified neoadjuvant chemotherapy in early-responding breast cancer: phase iii randomized gepartrio study

JOURNAL OF THE NATIONAL CANCER INSTITUTE ADVANCE ACCESS ORIGINALLY PUBLISHED ONLINE ON APRIL 8, 2008 JNCI Journal of the National Cancer Institute 2008 100(8):552-562; doi:10.This Article All Versions of this Article: 100/8/552 _most recent_ Services Google Scholar PubMed Related Collections Social Bookmarking ARTICLES INTENSIFIED NEOADJUVANT CHEMOTHERAPY IN EARLY-RESPONDING BREAST CANCER: PHASE III RANDOMIZED GEPARTRIO STUDY Gunter von Minckwitz, Sherko Kmmel, Petra Vogel, Claus Hanusch, Holger Eidtmann, Jrn Hilfrich, Bernd Gerber, Jens Huober, Serban Dan Costa, Christian Jackisch, Sibylle Loibl, Keyur Mehta, Manfred Kaufmann; for the German Breast Group AFFILIATIONS OF AUTHORS: German Breast Group, Frankfurt, Germany (GvM, SL, KM); Universitts-Frauenklinik, Essen, Germany (SK); Frauenklinik, Horst Schmidt Kliniken, Wiesbaden, Germany (PV); Frauenklinik vom Roten Kreuz, Munich, Germany (CH); Universitts-Frauenklinik, Kiel, Germany (HE); Frauenklinik Henriettenstiftung, Hannover, Germany (J.Rostock, Germany (BG); Universitts-Frauenklinik, Tbingen, Germany (J.Magdeburg, Germany (SDC); Stdtisches Klinikum Offenbach, Offenbach, Germany (CJ); Universitts-Frauenklinik, Frankfurt, Germany (GvM, SL, MK) CORRESPONDENCE TO: Gunter von Minckwitz, MD, Universitts-Frauenklinik Frankfurt difference = 2.Interval = -1.6.= .More clinical (48.52.4.= -0.9.= .Sonographic (22.27.= 5%; 95% CI = 0.9..At surgery were observed with eight TAC cycles than with six TAC cycles.Rate of breast-conserving surgery was similar in both arms (67.68._P_ = .Grade 3 or 4 leukopenia and edema and various grade 1 or 2 adverse events were more frequent in patients receiving eight TAC cycles than in those receiving six cycles.Conclusion: Patients receiving eight TAC cycles had statistically significantly higher sonographic response rates but not pathologicalplete response rates than those receiving six TAC cycles.Also had more toxic effects.Far, eight cycles of TAC cannot be rmended for the whole group of patients responding to two initial cycles of TAC.CONTEXT AND CAVEATS PRIOR KNOWLEDGE Patients with an early response to neoadjuvant chemotherapy have chemosensitive tumors and a high probability for a pathologicalplete response at surgery.DESIGN Phase III randomized trial among previously untreated breast cancer patients who responded to two cycles of docetaxel, doxorubicin, and cyclophosphamide (TAC) that evaluated four or six more cycles of TAC, for a total of six or eight TAC cycles.Response rates and rates of breast-conserving surgery and adverse effects were also assessed.Patients who received eight TAC cycles had statistically significantly higher sonographic response rates and more toxic effects but not pathologicalplete response rates than those who received six TAC cycles.Eight cycles of TAC cannot be rmended for the whole group of patients who respond to two initial cycles of TAC.The power of the study to detect a statistically significant difference between arms was reduced because of the small sample size.In the eight-cycle arm than in the six-cycle arm discontinued treatment.Interobserver variability in the assessment of sonographic and clinical responses exists.October 24, 2007; revised February 11, 2008; accepted February 28, 2008.IN JNCI IN THIS ISSUE J Natl Cancer Inst 2008 100: 519.THIS ARTICLE HAS BEEN CITED BY OTHER ARTICLES: G.S.P.C.H.J.Gerber, J.S.Costa, C._et al.VERSUS DOCETAXEL-DOXORUBICIN-CYCLOPHOSPHAMIDE IN EARLY NONRESPONSIVE BREAST CANCER: PHASE III RANDOMIZED GEPARTRIO TRIAL J Natl Cancer Inst, April 16, 2008; 100(8): 542 - 551.J.And G.Hortobagyi CAN EARLY RESPONSE ASSESSMENT GUIDE NEOADJUVANT CHEMOTHERAPY IN EARLY-STAGE BREAST CANCER?Natl Cancer Inst, April 16, 2008; 100(8): 521 - 523.
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среда, 16 апреля 2008 г.

Special communication: guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation

Why this message is appearing and what you can do to make your experience on this site better.Select Journal or Resource JAMA & Archives Home JAMA Archives of Dermatology Facial Plastic Surgery Family Medicine (1992-2000) General Psychiatry Internal Medicine Neurology Ophthalmology OtolaryngologyHead & Neck Surgery Pediatrics Kevin P.MD, MHS; David S.MD, MPH; Harlan M.SM _JAMA. CONTEXT Authorship in biomedical publication provides recognition and establishes accountability and responsibility.Litigation related to rofecoxib provided a unique opportunity to examine guest authorship and ghostwriting, practices that have been suspected in biomedical publication but for which there is little documentation.OBJECTIVE To characterize different types and the extent of guest authorship and ghostwriting in 1 case study.DATA SOURCES Court documents originally obtained during litigation related to rofecoxib against Merck Department of Psychiatry, Harvard Medical School, Boston, Massachusetts, and McLean Hospital, Belmont, Massachusetts (Dr Hill); Department ofmunity Health, Brown University School of Medicine, Providence, Rhode Island (Dr Egilman); and Robert Wood Johnson Clinical Scholars Program and Section of Cardiovascular Medicine, Department of Medicine, Section of Health Policy and Administration, School of Public Health, Yale University School of Medicine, and Center for Oues Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut (Dr Krumholz).RELATED ARTICLES THIS WEEK IN _JAMA_ _JAMA. REPORTING MORTALITY FINDINGS IN TRIALS OF ROFECOXIB FOR ALZHEIMER DISEASE OR COGNITIVE IMPAIRMENT: A CASE STUDY BASED ON DOCUMENTS FROM ROFECOXIB LITIGATION Bruce M.And Richard A._JAMA. IMPUGNING THE INTEGRITY OF MEDICAL SCIENCE: THE ADVERSE EFFECTS OF INDUSTRY INFLUENCE Catherine D.And Phil B._JAMA.
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Oramed begins studies on its oral insulin capsule at hadassah medical center

Phase 2A trial is focused on assessing the safety and efficacy of the oral insulin capsule on 10 type 2 diabetes patients.Study is a continuation of the recently successfullypleted Phase 1 studies in Israel."We are pleased to have achieved this milestone of beginning Phase 2A clinical trials in Israel in the second quarter of this year," said Nadav Kidron, CEO of Oramed Pharmaceuticals.Have had much success with our past clinical trials, and are on schedule with reaching our planned milestones and hope that Oramed's oral insulin capsule will succeed in revolutionizing the current treatment for diabetes.ABOUT ORAMED PHARMACEUTICALS Oramed Pharmaceuticals is an Israeli-basedpany focused on the development of oral delivery solutions based on proprietary technology.Is one of the most rapidly growing diseases in the world and is one that requires constant and often unpleasant monitoring and drug therapy regimens.Is currently developing an orally ingestible insulin capsule for the treatment of diabetes.Also pursuing the development of oral delivery solutions for other drugs and vaccines.STATEMENTS Some of the statements contained in this press release are forward- looking statements which involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance or achievements of thepany, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval for our product candidates;petition from other pharmaceutical or biotechnologypanies; and thepany's ability to obtain additional funding required to conduct its research, development andmercialization activities.Refer to thepany's filings with the Securities and Exchangemission for aprehensive list of risk factors that could cause actual results, performance or achievements of thepany to differ materially from those expressed or implied in such forward looking statements.Undertakes no obligation to update or revise any forward-looking statements.PLEASE RATE THIS ARTICLE: (Hover over the stars then click to rate) PATIENT / PUBLIC: OR HEALTH PROFESSIONAL: USEFUL LINKS ADD TO: CONTACT OUR NEWS EDITORS For any corrections of factual information, or to contact the editors please use our .Send any medical news or health news press releases to: 2008 News Category Menu News By Email Navigation Links Health Professional Sites Patient Resource Sites Clinical Trials For Health Professionals Latest News For Diabetes 16 Apr 2008 16 Apr 2008 15 Apr 2008 Latest Videos for Diabetes There may be another thing that people with diabetes need to take care of: their balance.Some balance exercises and learn what you can do to keep on your feet.
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вторник, 15 апреля 2008 г.

How what and how much we eat (and drink) affects our risk of cancer

Consumption and risk of breast cancer in postmenopausal women: the NIH-AARP Diet and Health Study: Abstract 4168 One of the largest studies of its kind has found that alcohol is a substantial risk factor for development of the mostmon type of breast cancer the 70 percent of tumors that are classified as positive for both the estrogen and progesterone receptors (ER+/PR+).Report that even moderate alcohol consumption, defined as one or two drinks per day, increased risk of developing this kind of cancer, and the more a woman drank, the higher her risk.Women who did not drink at all, women who had three or more glasses of alcohol daily had as much as a 51 percent increased risk of ER+/PR+ breast cancer.Suggests that a woman should evaluate consumption of alcohol along with other known breast cancer risk factors, such as use of hormone replacement therapy," said the study's first author, Jasmine Q.A fourth-year medical student at the University of Chicago who is conducting this research as a recipient of the Howard Hughes Medical Institute-National Institutes of Health Research Scholarship at the National Cancer Institute's (NCI) Division of Cancer Epidemiology and Genetics.And her research colleagues from NCI say their analysis could not support a definitive conclusion as to whether alcohol influences development of other breast cancer tumor types.We have enough numbers to study alcohol's influence on ER+/PR+ breast cancer," she said.Studies have long suggested that use of alcohol may increase a woman's risk for developing breast cancer, and laboratory studies have shown that alcohol increases the amount of estrogen metabolites available in a woman's body, which can then act as a fuel for hormone-sensitive breast cancer.Few studies have looked at alcohol's effect on tumor type.This study, the researchers reviewed data from the NIH-AARP Diet and Health Study, which began in 1995.And her colleagues analyzed 184,418 postmenopausal women who enrolled in this cohort study, and who answered questions about their daily alcohol consumption.An average of seven years of follow-up, they found that 70 percent of women in the study drank alcohol; the average amount was a little less than a drink a day.The authors found that moderate drinking in women increased risk of developing breast cancer.Then identified 5,461 cases of invasive breast cancer, for which they had tumor type information on 2,391 cases.All, they analyzed data on 1,641 ER+/PR+, 366 ER-/PR-, 336 ER+/PR-, and 48 ER-/PR+ cases of invasive breast cancer.Researchers found that ER+/PR+ cancers showed a stronger association with alcohol than that seen in the overall group.Non-drinkers, women who consumed less than one drink daily, one to two drinks, and three or more daily drinks, the increase in relative risk for developing ER+/PR+ breast cancer was 7 percent, 32 percent, and 51 percent, respectively.The data suggested increased risks among the women with ER+/PR- breast cancer, the number of cases was relatively small, and this finding was not statistically significant.Increased risk of invasive breast cancer was observed across different types of alcohol consumed.Study at this point provides evidence for the notion that alcohol affects estrogen metabolism, which increases risk of hormone sensitive breast cancer," Lew said.More study is needed to clarify the effect of alcohol on other tumor types.Between ADH1B and ADH1C Haplotype Tag SNPs and Breast Cancer Risk, and the Interaction with Alcohol Drinking: Abstract 5814 Specific variations within two genes involved with alcohol metabolism are associated with an increased risk for breast cancer in postmenopausal women, according to a new study.Conducted by research groups led by Peter Shields, M.Professor of medicine and oncology at Georgetown University's Lombardiprehensive Cancer Center and Jo Freudenheim, Ph.Chair of social and preventive medicine at the State University of New York at Buffalo, indicates that sequence variations within the genes ADH1B and ADH1C may as much as double a postmenopausal woman drinker's risk for breast cancer.That variations in two genes coding for the alcohol dehydrogenase enzyme increase the risk of breast cancer among women who drink," said lead author Catalin Marian, M.Ph.A research instructor of cancer genetics and epidemiology at Georgetown.Their alcohol consumption, the higher their risk.And colleagues evaluated data from participants in the Western New York Exposure and Breast Cancer (WEB) Study, a population-based case-control study of breast cancer conducted by Freudenheim in women ages 35 to 79 from two western New York counties between 1996 and 2001.With primary, histologically confirmed breast cancer served as cases.Control participants were randomly selected and matched to cases by age, race and county of residence.Research team analyzed DNA samples taken from 991 women with breast cancer and 1,698 controls.Found that variations within the DNA sequences rs1042026 in the gene ADH1B and rs1614972 in the gene ADH1C were associated with an increased breast cancer risk for postmenopausal women.The rs1042026 sequence, the risk of breast cancer for women who had a variant form of the gene and who drank alcohol was nearly twice that of women who abstained.Risk of breast cancer increased with the level of alcohol consumption.The rs1614972 sequence, the variant form of the gene offered a protective effect against breast cancer that varied inversely proportional with the drinking level.More alcohol women drank, the less protective the effect and the higher their risk of developing breast cancer.That the work needs to be explored further and replicated by other studies, as the research showed these sequence variations were associated with increased risk of breast cancer but were not necessarily biologically responsible for this effect.Two genes encode for enzymes involved in the metabolization of alcohol, so variations in these genes can increase or decrease the rate of alcohol metabolism," Marian said.Have to keep in mind that the gene sequence variations we observed are not located directly in coding regions, but they may be associated and inherited together with other variations that have this effect on the enzyme function.Energy balance modulates multistage epithelial carcinogenesis in mouse skin: Abstract 1604 New data suggest that dietary energy balance may affect the risk for skin tumor development.Believe that these effects of dietary energy balance are mediated by changes in signaling through the epidermal growth factor receptor (EGFR) and the insulin-like growth factor 1 receptor (IGF-1R).Have demonstrated that dietary energy balance directly modulates activation of cell surface receptors, specifically the EGFR and the IGF-1R, which subsequently affects signaling through downstream pathways, such as Akt and mTOR.Energy balance inhibits, while positive energy balance enhances, signaling through these pathways, thereby modulating cellular growth, proliferation, and survival," said Tricia Moore, lead author of the study.Energy balance refers to the balance between caloric intake and energy expenditure, according to the report.Findings from both epidemiological and experimental studies suggest chronic positive energy balance, which can lead to obesity, increases the risk of developing multiple cancers.A negative energy balance state, as induced by calorie restriction, decreases these risks in most instances, the researchers said.The present study, the researchers used a two-stage skin carcinogenesis model to examine the effects of both positive and negative dietary energy balance on skin tumor promotion and progression.Of female mice received 25 nmol of 7,12-dimethylbenz(a)anthracene (DMBA), a cancer inducing chemical, and were then placed on one of four dietary treatment regimens to generate either a positive or negative energy balance state.Four weeks on their respective diets, the mice received two other cancer inducing chemicals (acetone, 3.Or 6.12-O-tetradecanoylphorbol-13-acetate (TPA)) twice weekly for the duration of the study.Energy balance, as induced by both 15 percent and 30 percent calorie restriction, led to inhibition of papilloma (benign skin tumors that can potentially lead to skin cancer) formation, depending on TPA dose, whenpared to either positive energy balance inducing diet.Tumor multiplicity, as measured by papillomas per mouse, was slightly higher among those receiving the more calorie dense fat diet, this was not different from the less calorie dense fat diet with either dose of TPA, the researchers noted.Impact of dietary energy balance manipulation on the conversion of papillomas to squamous cell carcinomas in this model of multistage skin carcinogenesis is also being assessed.Have also shown that dietary energy balance alters signaling through the Akt and mTOR pathways, both of which are related to TPA-mediated skin tumor development.Propose that the mechanism for the effect of dietary energy balance on Akt and mTOR signaling may be mediated, in part, by changes in serum IGF-1 levels, which then alters signaling through the IGF-1R and EGFR.Findings will provide the basis for future translational studies targeting the Akt/mTOR pathway viabinations of lifestyle (e.Moderate calorie restriction regimens) and pharmacologic approaches for the prevention and control of obesity-related epithelial cancers in humans," said John DiGiovanni, Ph.Director of M.Anderson Cancer Center Science Park Research Division, in whose lab this work is being conducted.Of in utero folic acid supplementation on colorectal cancer in the offspring in a chemical carcinogenic rodent model: Abstract 2098 Although folic acid fortification has proven to lower rates of neural tube defects and some childhood cancers, there is a growing body of evidence that too much folic acid may increase one's risk of developing colorectal cancer.New study suggests that folic acid supplementation provided in utero, but not postnatally, may protect offspring from developing colorectal cancer.Study provides important insights into the critical role of timing of folic acid intervention in colorectal cancer development and progression.May prevent 'new' cancers in the colorectum," said Karen K.A graduate medical student at the University of Toronto.University of Toronto research team had previously demonstrated that folic acid supplementation could promote the progression of the earliest precursor to colorectal cancer.Study focused on whether or not folic acid supplementation in utero could reduce the risk of colorectal cancer in the offspring.Placed female rats on a control diet or folic acid supplemented diet three weeks prior to breeding, and they stayed on this diet throughout pregnancy and lactation.Male pups from each group were then fed a control or folic acid supplemented diet at weaning.Five to six weeks, the pups were injected with a colorectal cancer causing chemical, and, at 34 weeks, researchers measured tumor incidence, multiplicity and burden as well as plasma folate, homocysteine and liver folate concentrations.From mothers on the control diet had a nearly three-fold increased risk of developing colorectal cancerpared with those from rats on folic acid supplementation.Folic acid supplementation significantly decreased the risk of offspring developing colorectal cancer while postnatal folic acid supplementation had no significant effect on the incidence of tumor development.Though folic acid has been successful in reducing neural tube defect rates and is beneficial against some childhood cancers, the potential long term benefits and adverse effects of the drastically increased folate status in the North American population needs to be closely monitored," said Sie.The continuing debate and controversy surrounding mandatory folic acid fortification and supplementation, it is critical to determine safe and effective doses and timing of folic acid intervention for colorectal cancer prevention.Mission of the American Association for Cancer Research is to prevent and cure cancer.In 1907, AACR is the world's oldest and largest professional organization dedicated to advancing cancer research.Membership includes nearly 27,000 basic, translational, and clinical researchers; health care professionals; and cancer survivors and advocates in the United States and more than 70 other countries.Marshals the full spectrum of expertise from the cancermunity to accelerate progress in the prevention, diagnosis and treatment of cancer through high-quality scientific and educational programs.Funds innovative, meritorious research grants.AACR Annual Meeting attracts more than 17,000 participants who share the latest discoveries and developments in the field.Throughout the year present novel data across a wide variety of topics in cancer research, treatment, and patient care.Five major peer-reviewed journals: Cancer Research; Clinical Cancer Research; Molecular Cancer Therapeutics; Molecular Cancer Research; and Cancer Epidemiology, Biomarkers "> PLEASE RATE THIS ARTICLE: (Hover over the stars then click to rate) PATIENT / PUBLIC: OR HEALTH PROFESSIONAL: USEFUL LINKS ADD TO: CONTACT OUR NEWS EDITORS For any corrections of factual information, or to contact the editors please use our .Send any medical news or health news press releases to: 2008 News Category Menu News By Email Navigation Links Health Professional Sites Patient Resource Sites Clinical Trials Latest News For Cancer / Oncology 15 Apr 2008 15 Apr 2008 15 Apr 2008 Latest Videos for Cancer Imatinib, or Gleevec, is a targeted anti-cancer drug that can keep chronic myelogenous leukemia (CML) in check for most patients for many years.Is important for patients to take imatinib as prescribed by their doctor to fight the disease and to guard against resistance.Many men will have advanced prostate cancer without any noticeable symptoms.
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