Lovenox(enoxaparin sodium) solution [sanofi-aventis u.s. llc]

Risk also appears to be increased by traumatic or repeated epidural or spinal puncture.Patients should be frequently monitored for signs and symptoms of neurological impairment.Neurologicpromise is noted, urgent treatment is necessary.The physician should consider the potential benefit versus risk before neuraxial intervention in patients anticoagulated or to be anticoagulated for thromboprophylaxis (see also , and ).DESCRIPTION Lovenox Injection is a sterile aqueous solution containing enoxaparin sodium, a low molecular weight heparin.Injection is available in two concentrations: 1.MG PER ML -Prefilled Syringes 30 mg / 0.40 mg / 0.-Graduated Prefilled Syringes 60 mg / 0.80 mg / 0.100 mg / 1 mL -Multiple-Dose Vials 300 mg / 3 mL Lovenox Injection 100 mg/mL Concentration contains 10 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1000 IU ) per 0.Water for Injection.2.MG PER ML -Graduated Prefilled Syringes 120 mg / 0.150 mg / 1 mL Lovenox Injection 150 mg/mL Concentration contains 15 mg enoxaparin sodium (approximate anti-Factor Xa activity of 1500 IU ) per 0.Water for Injection.The Lovenox prefilled syringes and graduated prefilled syringes are preservative-free and intended for use only as a single-dose injection.Multiple-dose vial contains 15 mg benzyl alcohol per 1 mL as a preservative.And for dosage unit descriptions.PH of the injection is 5.7.Enoxaparin sodium is obtained by alkaline depolymerization of heparin benzyl ester derived from porcine intestinal mucosa.Structure is characterized by a 2-O-sulfo-4-enepyranosuronic acid group at the non-reducing end and a 2-N,6-O-disulfo-D-glucosamine at the reducing end of the chain.(ranging between 15% and 25%) of the enoxaparin structure contains an 1,6 anhydro derivative on the reducing end of the polysaccharide chain.Drug substance is the sodium salt.Average molecular weight is about 4500 daltons.Molecular weight distribution is: 8000 daltons 18% STRUCTURAL FORMULA X = Percent of polysaccharide chain containing 1,6 anhydro derivative on the reducing end.R X= 15 to 25% n= 0 to 20 100 - X H n =1 to 21 CLINICAL PHARMACOLOGY Enoxaparin is a low molecular weight heparin which has antithrombotic properties.Humans, enoxaparin given at a dose of 1.(SC) is characterized by a higher ratio of anti-Factor Xa to anti-Factor IIa activity (meanSD, 14.(based on areas under anti-Factor activity versus time curves)pared to the ratios observed for heparin (meanSD, 1.Increases of up to 1.Control values were seen in the thrombin time (TT) and the activated partial thromboplastin time (aPTT).At a 1 mg/kg dose (100 mg / mL concentration), administered SC every 12 hours to patients in a large clinical trial resulted in aPTT values of 45 seconds or less in the majority of patients (n = 1607).PHARMACOKINETICS (CONDUCTED USING 100 MG / ML CONCENTRATION) ABSORPTION Maximum anti-Factor Xa and anti-thrombin (anti-Factor IIa) activities occur 3 to 5 hours after SC injection of enoxaparin.Peak anti-Factor Xa activity was 0.G/mL) and 0.(3.The 20 mg and the 40 mg clinically tested SC doses, respectively.(n = 46) peak anti-Factor Xa activity was 1.At steady state in patients with unstable angina receiving 1 mg/kg SC every 12 hours for 14 days.Absolute bioavailability of enoxaparin, after 1.Given SC, based on anti-Factor Xa activity is approximately 100% in healthy volunteers.Pharmacokinetics appear to be linear over the rmended dosage ranges (see ).Repeated subcutaneous administration of 40 mg once daily and 1.Once-daily regimens in healthy volunteers, the steady state is reached on day 2 with an average exposure ratio about 15% higher than after a single dose.Enoxaparin activity levels are well predicted by single-dose pharmacokinetics.Subcutaneous administration of the 1 mg/kg twice daily regimen, the steady state is reached from day 4 with mean exposure about 65% higher than after a single dose and mean peak and trough levels of about 1.0.Respectively.On enoxaparin sodium pharmacokinetics, this difference in steady state is expected and within the therapeutic range.Although not studied clinically, the 150 mg/mL concentration of enoxaparin sodium is projected to result in anticoagulant activities similar to those of 100 mg/mL and 200 mg/mL concentrations at the same enoxaparin dose.A daily 1.SC injection of enoxaparin sodium was given to 25 healthy male and female subjects using a 100 mg/mL or a 200 mg/mL concentration the following pharmacokinetic profiles were obtained (see table below): Pharmacokinetic Parameters After 5 Days of 1.SC Once Daily Doses of Enoxaparin Sodium Using 100 mg/mL or 200 mg/mL Concentrations CONCENTRATION ANTI-XA ANTI-IIA HEPTEST APTT Means SD at Day 5 and 90% Confidence Interval (CI) of the ratio Median (range) Amax (IU/mL or О" sec) 100 mg/mL 1.23 (0.(16.(4.1.26 (0.(17.CI 102-110% 102-111% tmax (h) 100 mg/mL 3 (2-6) 4 (2-5) 2.(2-4.(2-6) 4.3 (2-5) 3 (2-5) AUC (ss) (hIU/mL or hО" sec) 100 mg/mL 14.54 (0.200 mg/mL 15.77 (0.90% CI 105-112% 103-109% DISTRIBUTION The volume of distribution of anti-Factor Xa activity is about 4.ELIMINATION Following intravenous (i.Dosing, the total body clearance of enoxaparin is 26 mL/min.I.Dosing of enoxaparin labeled with the gamma-emitter, 99mTc, 40% of radioactivity and 8 to 20% of anti-Factor Xa activity were recovered in urine in 24 hours.Based on anti-Factor Xa activity was 4.After a single SC dose to about 7 hours after repeated dosing.40 mg SC once a day dose, significant anti-Factor Xa activity persists in plasma for about 12 hours.Following SC dosing, the apparent clearance (CL/F) of enoxaparin is approximately 15 mL/min.METABOLISM Enoxaparin sodium is primarily metabolized in the liver by desulfation and/or depolymerization to lower molecular weight species with much reduced biological potency.Clearance of active fragments represents about 10% of the administered dose and total renal excretion of active and non-active fragments 40% of the dose.SPECIAL POPULATIONS GENDER Apparent clearance and Amax derived from anti-Factor Xa values following single SC dosing (40 mg and 60 mg) were slightly higher in males than in females.Source of the gender difference in these parameters has not been conclusively identified, however, body weight may be a contributing factor.GERIATRIC Apparent clearance and Amax derived from anti-Factor Xa values following single and multiple SC dosing in elderly subjects were close to those observed in young subjects.Once a day SC dosing of 40 mg enoxaparin, the Day 10 mean area under anti-Factor Xa activity versus time curve (AUC) was approximately 15% greater than the mean Day 1 AUC value..
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Tekturna(aliskiren fumarate) tablet, film coated [novartis pharmaceuticals corporation]

WARNINGS: Fetal/Neonatal Morbidity and Mortality.DESCRIPTION Aliskiren, the activeponent of Tekturna(R) Tablets, is an orally active, nonpeptide, potent renin inhibitor.Is present in Tekturna Tablets as its hemifumarate salt.Hemifumarate is chemically described as (2S,4S,5S,7S)-N-(2-Carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8octanamide hemifumarate and its structural formula is Molecular formula: C30H53N3O6 0.Aliskiren hemifumarate is a white to slightly yellowish crystalline powder with a molecular weight of 609.551.It is soluble in phosphate buffer, n-Octanol, and highly soluble in water.Tekturna is available for oral administration as film-coated tablets containing 150 mg, and 300 mg of aliskiren base and the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, iron oxide colorants, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, talc, and titanium dioxide.CLINICAL PHARMACOLOGY MECHANISM OF ACTION Renin is secreted by the kidney in response to decreases in blood volume and renal perfusion.Cleaves angiotensinogen to form the inactive decapeptide angiotensin I (Ang I).I is converted to the active octapeptide angiotensin II (Ang II) by angiotensin-converting enzyme (ACE) and non-ACE pathways.II is a powerful vasoconstrictor and leads to the release of catecholamines from the adrenal medulla and prejunctional nerve endings.Also promotes aldosterone secretion and sodium reabsorption.These effects increase blood pressure.II also inhibits renin release, thus providing a negative feedback to the system.Cycle, from renin through angiotensin to aldosterone and its associated negative feedback loop, is known as the renin-angiotensin-aldosterone system (RAAS).Is a direct renin inhibitor, decreasing plasma renin activity (PRA) and inhibiting the conversion of angiotensinogen to Ang I.Aliskiren affects other RAASponents, e.ACE or non-ACE pathways, is not known.All agents that inhibit the RAAS, including renin inhibitors, suppress the negative feedback loop, leading to apensatory rise in plasma renin concentration.This rise occurs during treatment with ACE inhibitors and ARBs, the result is increased levels of PRA.Aliskiren, however, the effect of increased renin levels is blocked, so that PRA, Ang I and Ang II are all reduced, whether aliskiren is used as monotherapy or inbination with other antihypertensive agents.Reductions in clinical trials ranged from approximately 50%-80%, were not dose-related and did not correlate with blood pressure reductions.Clinical implications of the differences in effect on PRA are not known.PHARMACOKINETICS Aliskiren is a poorly absorbed (bioavailability about 2.With an approximate accumulation half life of 24 hours.Blood levels are reached in about 7-8 days.ABSORPTION AND DISTRIBUTION Following oral administration, peak plasma concentrations of aliskiren are reached within 1 to 3 hours.Taken with a high fat meal, mean AUC and Cmax of aliskiren are decreased by 71% and 85%, respectively.The clinical trials of aliskiren, it was administered without requiring a fixed relation of administration to meals.METABOLISM AND ELIMINATION About one-fourth of the absorbed dose appears in the urine as parent drug.
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Obesity Raises Cancer Risk (HealthDay)

Only News Photos Video/Audio OBESITY RAISES CANCER RISK BY AMANDA GARDNER _HealthDay Reporter_ _2 hours, 16 minutes ago_ FRIDAY, Feb.News) The more weight you carry on your body, the greater your odds of developing cancer, British researchers report.This is true not only of fairlymon cancers such as colon and breast, but also of lesser known varieties, including gallbladder.The degree of risk differs between men and women and among different ethnic groups, report the authors of aprehensive new paper appearing in this weeks issue of _The Lancet_."This is a profoundly important issue.The obesity epidemic is a huge problem itself, and the relationship to cancer is only one of the many adverse health effects of being overweight and obese," said Dr.Thun, head of epidemiological research at the American Cancer Society.Evidence has been accumulating now for over 10 years..Study tries to provide a quantitative measure of how much the relative risk goes up with each increment, basically jumping from one BMI category to another.Although extra fat has already been identified by research as a risk factor for several different types of cancer, Thun said, "the problem of obesity is so large and so difficult to solve that theres a very sound reason for ongoing studies of things that have be increasingly well-known, just because it helps the momentum in stimulating approaches that will actually help people maintain a healthy weight.Last year, a report issued by the American Institute of Cancer Research and the U.World Cancer Research Fund concluded that body fat is associated with an increased risk for several different types of cancer including esophageal adenocarcinoma, as well as cancers of the pancreas, colon and rectum, breast (postmenopausal), endometrium and kidney.Although that report was one of the mostprehensive to date, it did leave some questions unanswered.Instance, are there associations between lessmon cancers and body weight, and do the associations differ between the sexes and people of different ethnic backgrounds?The issue is a pressing one, with about two-thirds of adult men and women in the United States overweight or obese.Number is only expected to increase as people continue to eat more and exercise less.This study, from scientists at the University of Manchester, analyzed 141 articles involving 282,137 cancer cases and 20 different types of malignancies to determine the cancer risk associated with a 5 kilogram-per-meter-squared increase in BMI, roughly the increase that would bump a person from middle-normal weight into overweight.In men, such an increase in BMI raised the risk of esophageal adenocarcinoma by 52 percent, thyroid cancer by 33 percent, and colon and kidney cancer by 24 percent each.In women, the same increase in BMI increased the risk of endometrial and gallbladder cancer by 59 percent each, esophageal adenocarcinoma by 51 percent, and kidney cancer by 34 percent.In men, there were weaker associations between increased BMI and rectal cancer and melanoma.Women, there were weaker associations between increased BMI and postmenopausal breast, pancreatic, thyroid and colon cancers.In both genders, there were associations between increased BMI and leukemia, multiple myeloma and non-Hodgkins lymphoma.For colon cancer, the associations were stronger in men than in women (24 percent vs.Percent).There were stronger associations in Asia-Pacific populations between greater BMI and both premenopausal and postmenopausal breast cancers.Although the main message is still to maintain a healthy weight, this research might indicate earlier screening for certain cancers, said Dr.Interim chief of the gastroenterology division at Ireland Cancer Center of University Hospitals and Caseprehensive Cancer Center in Cleveland.Someone is obese, then lower the threshold for screening," he said.Of the cancers they identified is esophageal adenocarcinoma, which is not asmon as colon cancer, but it is increasing in incidence.Is thought to be related to reflux, so as a gastroenterologist, if I have a patient who has reflux and is obese, I might lower the threshold for doing an endoscopy.Other cancers like colon cancer, those guidelines are pretty well-established, and this probably wouldnt change practice.Experts arent sure why extra fat can lead to malignancies, but changes in the circulating levels of various hormones (insulin, insulin-like growth factors and sex steroids) might explain the link.Heres more bad news as the world heads for a smoke-free future: An apanyingmentary from Swedish researchers notes that as people quit smoking (the biggest cause of cancer in developed countries), weight gain may be the main lifestyle factor contributing to new cancers.MORE INFORMATION Visit the for more on the different types of cancer.
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Salmeterol/fluticasone propionate via diskus(tm) once daily versus fluticasone propionate twice daily in patients with mild asthma not previously receiving maintenance corticosteroids.

ARTICLE LINKS: SALMETEROL/FLUTICASONE PROPIONATE VIA DISKUS(TM) ONCE DAILY VERSUS FLUTICASONE PROPIONATE TWICE DAILY IN PATIENTS WITH MILD ASTHMA NOT PREVIOUSLY RECEIVING MAINTENANCE CORTICOSTEROIDS.ORIGINAL RESEARCH ARTICLE Clinical Drug Investigation._ Chuchalin, Alexander 1; Jacques, Loretta 2; Frith, Lucy 2 _ ABSTRACT: Background: and objective: The efficacy and safety of twice-daily inhaled salmeterol/fluticasone propionatebination (SFC) therapy have been well established in the treatment of adults and adolescents with asthma.Administration of SFC could also be appropriate in patients with mild persistent asthma.Study aimed to investigate whether once-daily SFC 50 g twice daily, and more effective than twice-daily placebo, over 52 weeks as initial maintenance therapy in patients with mild persistent asthma.Was a randomized, double-blind, double-dummy, placebo-controlled, multicentre, parallel-group study carried out in primary and secondary care.Aged between 12 and 79 years with a documented clinical history of asthma for >=6 months who were currently receiving inhaled short-acting g (i.Twice the dose of FPpared with SFC) or placebo for 52 weeks.Primary efficacy endpoints were mean morning peak expiratory flow (PEF), as recorded by patients prior to the use of bronchodilator or study medication, and the rate of investigator-recorded asthma exacerbations.Receiving twice-daily FP and once-daily SFC showed greater improvements in mean morning PEFpared with those receiving placebo (FP, difference in means 20.95% CI 14.P < 0.Difference in means 14.95% CI 9.P < 0.The difference in adjusted mean PEF between once-daily SFC and twice-daily FP was -5.(95% CI -9. PEF results showed that once-daily SFC was non-inferior to twice-daily FP.52 weeks, there was a 35% reduction in exacerbation rates with once-daily SFC, which in this respect demonstrated superiority over placebo (p < 0.Between once-daily SFC and twice-daily FP with respect to exacerbation rates was not shown.SFC significantly improved clinic forced expiratory flow between 25% and 75% of forced vital capacity (difference in means 0.P < 0.Clinic PEF (difference in means 10.P < 0.FP.Treatments were well tolerated and the safety profile of each was similar to that seen with placebo.Patients with mild persistent asthma not previously receiving maintenance therapy, once-daily SFC 50 g with respect to mean morning PEF.In this study, once-daily SFC was not as efficacious as twice-daily FP in reducing asthma exacerbation rates.
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Insulin sensitivity in type 1 diabetic children and adolescents

2004 TO CITE THIS ARTICLE: A.I.Mianowska, J.A.E.W.Bodalski (2008) Insulin sensitivity in Type 1 diabetic children and adolescents doi:10.02357.Abstract ORIGINAL ARTICLE INSULIN SENSITIVITY IN TYPE 1 DIABETIC CHILDREN AND ADOLESCENTS A.Pietrzak, B.J.H.Keenan, E.W.And J.Department of Children's Diseases, Medical University of Lodz, Poland, Vascular Cell Biology, Joslin Diabetes Center, Boston, MA, USA and Department of Pediatric Allergology, Gastroenterology and Nutrition, Medical University of Lodz, Poland ABBREVIATIONS BMI, body mass index; DBP, diastolic blood pressure; HbA1c, glycated haemoglobin; HDL, high-density lipoprotein; lbm, lean body mass; LDL, low-density lipoprotein; SBP, systolic blood pressure; SDS, standard deviation score _Correspondence to_: Agnieszka Szadkowska, Department of Children's Diseases, Medical University of Lodz, Sporna 36/50, 91-738 d, Poland.Keywords adolescents, children, diabetes, insulin sensitivity, obesity Diabet.(2008) ABSTRACT Aim To estimate insulin sensitivity in Type 1 diabetic children and adolescents, and assess the relationship between insulin sensitivity and clinical markers of adiposity and parameters of the metabolic syndrome.Methods A total of 202 patients aged 8-18 years with Type 1 diabetes and disease duration 1.Participated.Sensitivity was estimated by glucose uptake during an euglycaemic-hyperinsulinaemic clamp and was calculated as the average amount of glucose (Mlbm = mg/kglbm/min) required to maintain euglycaemia.Pressure, glycated haemoglobin (HbA1c) and lipid concentrations were measured.The Mlbm value ranged from 4.25.(mean 9.Mg/kglbm/min).Was a significant relationship between M value and patients' age (_r_ = -0.< 0.Insulin sensitivity decreased significantly with the onset of puberty; hence, it was significantly lower in pubertal and post-pubertal adolescents.Significantly more insulin resistant than boys (9. 10.Mg/kglbm/min, _P_ = 0.Sensitivity correlated with body mass index (_r_ = -0.< 0.Circumference (_r_ = -0.< 0.Skin fold (_r_ = -0.= 0.Skin fold (_r_ = -0.= 0.Fat (_r_ = -0.= 0.There was a relationship between Mlbm value, cholesterol (_r_ = -0.= 0.Cholesterol (_r_ = 0.= 0.(_r_ = -0.= 0.= -0.< 0.Systolic blood pressure (_r_ = -0.= 0.Insulin resistance was related to HbA1c (_r_ = -0.= 0.Additionally, there was a correlation between Mlbm value and insulin dose.Conclusions Children and adolescents with Type 1 diabetes mellitus have a very wide range of insulin sensitivity, which is determined by sex, age, amount of adipose tissue and glycaemic control.THIS ARTICLE SEARCH InSynergyPubMed (MEDLINE)CrossRefBy keywordsadolescentschildrendiabetesinsulin sensitivityobesityBy authorA.PietrzakB.Bodalska-LipiskaH. Toporowska-KowalskaW.
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Are coenzyme q10 and fish oils safe in type 2 diabetics?

Pilot service has been created to help members of the primary care teams of England get answers to their clinical questions.This is the first visit to the site we rmend you read "".View by speciality MOST RECENT QUESTIONS: (Please click on a question for the answer) Are Coenzyme Q10 and fish oils safe in type 2 diabetics?INTERPRETATION: Initial question: An overweight pt with type 2 Diabetes and hypertension has seen a 'nutritional therapist ' who rmends CoQ10 width:100%;" class="answer" style="font-family:Arial;"> Cochrane have very recently (November 2007) published the systematic review 'Omega-3 polyunsaturated fatty acids (PUFA) for type 2 diabetes mellitus' .Sub-heading for the review was: _"There is not enough evidence to say whether the benefits of taking omega-3 fats in type 2 diabetes mellitus exceed the harms for this group of people"_ While the actual conclusion was: _"Omega-3 PUFA supplementation in type 2 diabetes lowers triglycerides and VLDL cholesterol, but may raise LDL cholesterol (although results were non-significant in subgroups) and has no statistically significant effect on glycemic control or fasting insulin.With vascular events or mortality defined endpoints are needed.The American National Centre forplementary and Alternative Medicine have published a review of type 2 diabetes and dietary supplements and this discusses both fish oils and coenzyme Q10.Be noted that this was published before Cochrane published their updated review.The section on fish oil is too large to reproduce here, but we'll highlight a few passages we feel are more pertinent: _"Another analysis was published in 2004 by the Agency for Healthcare Research and Quality, of 18 studies on omega-3 fatty acids for a number of measurable oues in type 2 diabetes.Study confirmed virtually all the Cochrane authors' findings, except for finding no significant effect on LDL cholesterol._"Omega-3s appear to be safe for most adults at low-to-moderate doses.Have been some safety questions raised about fish oil supplements, because certain species of fish can be contaminated with substances from the environment, like mercury, pesticides, or PCBs._"Fish oil in high doses can possibly interact with, and affect the action of, certain medications, including blood-thinning drugs and drugs for high blood pressure.With regard to coenzyme Q10 they report: _"Coenzyme Q10, often referred to as CoQ10 (sometimes written as CoQ10; other names include ubiquinone and ubiquinol) is a vitamin-like substance.Cells make energy and acts as an antioxidant.Seafood contain small amounts of CoQ10.Are marketed as tablets and capsules.Summary of the research findings There have been few studies on CoQ10 and type 2 diabetes so far.Evidence is not sufficient to evaluate CoQ10's effectiveness as a CAM therapy in diabetes.Has not been shown to affect blood glucose control.It might have use against heart disease in people with diabetes, but well-designed studies looking at heart disease oues are needed to answer this question.Side effects and other risks CoQ10 appears to be safe for most of the adult population.It may interact with and affect the action of some medicines, including warfarin (a blood thinner) and medicines used for high blood pressure or cancer chemotherapy.Possible side effects of CoQ10 include nausea, vomiting, diarrhea, loss of appetite, and heartburn.1) 2) The NLH Question Answering Service aims to answer questions quickly, it is not a systematic review.You have any doubt as to the implications of this contact the Q&A Service Provider for further information.
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Contact allergy to mometasone furoate with cross-reactivity to group b corticosteroids

S.(2008) Contact allergy to mometasone furoate with cross-reactivity to group B corticosteroids Contact Dermatitis 58 (3), 180-181.Doi:10.01235.Abstract CONTACT ALLERGY TO MOMETASONE FUROATE WITH CROSS-REACTIVITY TO GROUP B CORTICOSTEROIDS Florian Seyfarth11Department of Dermatology and Allergology, Friedrich Schiller University Jena, 07743 Jena, GermanyFlorian Seyfarth, MD Klinik fr Dermatologie und Dermatologische Allergologie Erfurter Strae 35 07743 Jena Germany Tel: +00 49 3641937398 Fax: +00 49 3641937363 e-mail: florian. P.J.And S.Of Dermatology and Allergology, Friedrich Schiller University Jena, 07743 Jena, Germany Florian Seyfarth, MD Klinik fr Dermatologie und Dermatologische Allergologie Erfurter Strae 35 07743 Jena Germany Tel: +00 49 3641937398 Fax: +00 49 3641937363 e-mail: THIS ARTICLE SEARCH InSynergyPubMed (MEDLINE)CrossRefBy keywordscontact allergycontact dermatitiscross reactivitymometasoneBy authorFlorian SeyfarthP.
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Amlodipine/valsartan: fixed-dose combination in hypertension

, Volume 68, Number 3, 2008 , pp.PUBLISHER: Key: - Free Content - New Content - Subscribed Content - Free Trial Content ABSTRACT: Amlodipine, a dihydropyridine calcium channel blocker, and valsartan, an angiotensin II receptor blocker, are established antihypertensive agents.Of amlodipine/valsartan are available in several European countries and in the US.Titration with amlodipine and valsartan is generally rmended before changing to the fixed-dosebination.At approved dosage regimens, achieved significantly greater reductions in mean sitting diastolic and systolic blood pressure (BP) than amlodipine or valsartan monotherapy, or placebo in two randomized, double-blind, factorial trials in patients with mild to moderate hypertension.80-90% of patients receiving approved dosages of amlodipine/valsartan achieved a response, defined as a mean sitting diastolic BP 90 mmHg or a 10 mmHg reduction from baseline.Analyses of data from the two trials showed that the antihypertensive efficacy of amlodipine/valsartan in the elderly, Black patients and those with stage 2 hypertension was consistent with that observed in the overall study population.Reductions in BP were also observed in patients whose BP was previously uncontrolled on monotherapy (with various antihypertensives) who were switched (without washout) to amlodipine/valsartan in a phase IIIb-IV study.Was generally well tolerated in clinical trials.Particular, the incidence of peripheral oedema was significantly lower in patients receiving amlodipine/valsartan than in those treated with amlodipine monotherapy.KEYWORDS: ; ; ; DOCUMENT TYPE: Research article AFFILIATIONS: 1: Wolters Kluwer Health Adis, Auckland, New Zealand, an editorial office of Wolters Kluwer Health, Conshohocken, Pennsylvania, USA The full text article is available for purchase 59.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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Effect of prolonged intravenous glucose and essential amino acid infusions on nitrogen balance, muscle protein degradation and ubiquitin-conjugating enzyme gene expression in calves

Hypothesised that co-infusion of glucose (to stimulate insulin) and essential amino acids (EAA) would act additively to improve nitrogen balance by decreasing muscle protein degradation in association with alterations in muscle expression ofponents of the ubiquitin-proteasome proteolytic pathway.Methods We examined the effect of a 5 day intravenous infusions of saline, glucose, EAA and glucose + EAA, on urinary nitrogen excretion and muscle protein degradation.Carried out the study in 6 restrained calves since ruminants offer the advantage that muscle protein degradation can be assessed by excretion of 3 methyl-histidine and multiple muscle biopsies can be taken from the same animal.The final day of infusion blood samples were taken for hormone and metabolite measurement and muscle biopsies for expression of ubiquitin, the 14-kDa E2 ubiquitin conjugating enzyme, and proteasome sub-units C2 and C8.Results On day 5 of glucose infusion, plasma glucose, insulin and IGF-1 concentrations were increased while urea nitrogen excretion and myofibrillar protein degradation was decreased.Of glucose + EAA prevented the loss of urinary nitrogen observed with EAA infusions alone and enhanced the increase in plasma IGF-1 concentration but there was no synergistic effect of glucose + EAA on the decrease in myofibrillar protein degradation.MRNA expression of the ubiquitin conjugating enzyme,14-kDa E2 and proteasome sub-unit C2 were significantly decreased, after glucose but not amino acid infusions, and there was no further response to thebined infusions of glucose + EAA.Conclusion Prolonged glucose infusion decreases myofibrillar protein degradation, prevents the excretion of infused EAA, and acts additively with EAA to increase plasma IGF-1 and improve net nitrogen balance.Was no evidence of synergistic effects between glucose + EAA infusion on muscle protein degradation or expression ofponents of the ubiquitin-proteasome proteolytic pathway.
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Merck will pay $671m to settle claims that it overcharged medicaid for prescription drugs, bribed physicians

First lawsuit was filed in Pennsylvania in 2000 and Nevada in 2005 and was joined by the and all states except Arizona.The suit, a former employee alleged that thepany provided Zocor, the anticholesterol treatment Mevocor and Vioxx to hospitals at discounts of more than 90% if the hospitals helped thepany reach market-share goals.Practice provided an unfair incentive for physicians to prescribe the drugs, the plaintiffs said.Under federal law, drug manufacturers must offer Medicaid the best price that they offer to any customer, but drugs sold at discounts of 90% or more do not need to be disclosed to the government.Exception was intended to allow drugpanies to make less-costly prescription drugs available to charitable organizations.The law does not specify who can receive the undisclosed discounts, the plaintiffs argued that the hospitals could not qualify because they agreed to sell specified volumes, and Merck was essentially using the discount as a marketing tool (Rubenstein/Johnson, Wall Street Journal, 2/8).In addition, the plaintiffs claim that Merck paid physicians so-called consulting or training fees, which were actually kickbacks for prescribing Zocor and Vioxx (Finch, , 2/8).Lawsuit examined violations from 1997 to 2001 at 600 to 800 hospitals nationwide, according to Assistant U.Attorney Viveka Parker and Virginia Gibson, chief of the office's civil division.Merck in a statement did not admit wrongdoing but said that the lawsuit was a result of a misunderstanding ofplex Medicaid rules.That in 2001 thepany implemented new rules for its sales force to prevent such activity from occurring (Stark, , 2/8).Pay $399 million to settle the lawsuit, with $218 million paid to the federal government and $181 million to the 49 states and Washington, D.For the second lawsuit, which involved similar allegations for Pepcid and was originally filed in Louisiana in 1999, Merck will pay $250 million, divided among the federal government and the same 49 states (Wall Street Journal, 2/8).MENTS Merck spokesperson Ronald Rogers said, "What we have here is a disagreement (over) the rules of the Medicaid rebate program," adding, "At the time that these pricing programs were in place, Merck believes that it acted in good faith andplied with the regulations that were in place at the time.Continued, "These civil settlements were the best and most appropriate way to resolve these lengthy investigations" (AP/Houston Chronicle, 2/8).U.Attorney General Michael Mukasey said that the settlement represents "one of the largest health care fraud settlements ever achieved by the Justice Department" and that the government will "hold drugpanies accountable for devising pricing schemes that deliberately seek to deny federal health care programs the same lower prices for drugs that are available to othermercial customers" (Cohen, , 2/8).BROADCAST COVERAGE ABC's "" on Thursday reported on the settlement.Segment includesments from U.Attorney Patrick Meehan and attorney Mark Kleiman, who represents the whistleblower in the case (Thomas, "World News," ABC, 2/7).Of the segment and expanded ABC News coverage are available ."" on Friday also reported on the settlement (Montagne, "Morning Edition," NPR, 2/8).Of the segment is available .Reprinted with kind permission from .Can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at .Daily Health Policy Report is published for kaisernetwork.Service of The Henry J.Family Foundation 2005 Advisory Boardpany and Kaiser Family Foundation.Rights reserved.HOW INTERESTING WAS THIS ARTICLE?Not Very.
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Urinary cortisol to cortisone metabolites ratio in prednisone-treated and spontaneously hypertensive patients.

ARTICLE LINKS: URINARY CORTISOL TO CORTISONE METABOLITES RATIO IN PREDNISONE-TREATED AND SPONTANEOUSLY HYPERTENSIVE PATIENTS.ORIGINAL PAPERS Journal of Hypertension.March 2008.Olivieri, Oliviero a; Pizzolo, Francesca a; Ravagnani, Viviana b; Moretti, Lorenzo a; Carletto, Antonio b; Faccini, Giovanni c; Pasini, Francesco d; Friso, Simonetta a; Corrocher, Roberto a _ ABSTRACT: Objective and methods: Prednisone and its active metabolite prednisolone, both substrates for 11-HSD2), may represent a pharmacological challenge for the enzyme.Aim of the present work was to define the possible role of abnormal cortisol/cortisone handling, as revealed by an urinary tetrahydrocortisol + allotetrahydrocortisol (THFs)/tetrahydrocortisone (THE) ratio between 1.3.Measuring urinary cortisol and cortisone metabolites in: normotensive individuals (n = 100) who received 7-8 mg/day of oral prednisone and were then followed for development of hypertension; essential hypertensive (EH) participants from primary care (n = 103); and EH hypertensive patients referred to the Hypertension Unit (n = 141).One-third (14 out of 47, 30%) of glucorticoid-treated patients who developed hypertension showed a THFs/THE ratio >1.Seen in 3% (n = 3) and 14% (n = 19) of primary and tertiary care hypertensive patients, respectively.THFs/THE ratio >1.Associated with a 3.Risk of hypertension after glucocorticoid therapy, regardless of duration and intensity of prednisone therapy.Number of EH patients and glucocorticoid-treated participants shared a similar phenotype, characterized by both arterial hypertension and elevated urinary THFs/THE ratio.A phenotype is moremon in severely, rather than in mildly, hypertensive patients.Lippincott Williams & Wilkins, Inc.Copyright 2008, Lippincott Williams & Wilkins.Rights reserved.By Lippincott Williams & Wilkins.
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Promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate(promethazine hydrochloride, phenylephrine hydrochloride and codeine phosphate) syrup [actavis mid atlantic llc]

7%.Inactive Ingredients: Citric acid, D&C Red #33, D&C Yellow #10, FD it is classified pharmacologically as a narcotic analgesic.Phosphate may be chemically designated as 7,8-Didehydro-4,5О±-epoxy-3-methoxy-17-methylmorphinan-6О±-ol phosphate (1:1)(salt) hemihydrate.The phosphate salt of codeine occurs as white, needle-shaped crystals or white crystalline powder.Phosphate is freely soluble in water and slightly soluble in alcohol.Has a molecular weight of 406.Molecular formula of C18H21NO3 H3PO4 H2O and the following structural formula: Promethazine hydrochloride, a phenothiazine derivative, is chemically designated as ()-10- phenothiazine monohydrochloride.Promethazine hydrochloride occurs as a white to faint yellow, practically odorless, crystalline powder which slowly oxidizes and turns blue on prolonged exposure to air.Is soluble in water and freely soluble in alcohol.Has a molecular weight of 320.Molecular formula of C17H20N2S HCl and the following structural formula: Phenylephrine hydrochloride is a sympathomimetic amine salt which is chemically indicated as (-)-m-Hydroxy-О±- benzyl alcohol hydrochloride.Occurs as white or nearly white crystals, having a bitter taste.Is freely soluble in water and alcohol.
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Can methylphenidate reduce fall risk in community-living older adults? a double-blind, single-dose cross-over study

Double-Blind, Single-Dose Cross-Over Study Journal of the American Geriatrics Society (OnlineEarly Articles).Doi:10.01623.BRIEF REPORTS CAN METHYLPHENIDATE REDUCE FALL RISK INMUNITY-LIVING OLDER ADULTS?DOUBLE-BLIND, SINGLE-DOSE CROSS-OVER STUDY Ron Ben-Itzhak, MD, Nir Giladi, MD, Leor Gruendlinger, MS, and Jeffrey M.PhD From the Movement Disorders Unit, Tel-Aviv Sourasky Medical Center, Tel Aviv, Israel; and Department of Geriatrics, Reuth Medical Center, Tel Aviv, Israel; Department of Neurology, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; and Department of Physical Therapy, Harvard Medical School, Boston, Massachusetts, and Division on Aging, Harvard Medical School, Boston, Massachusetts This work was presented in part at the 59th Annual Meeting of the American Academy of Neurology, Boston, Massachusetts, May 2007, and at the American Geriatrics Society meeting, Seattle, Washington, May 2007.Correspondence to Jeffrey M.
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Half of patients undergoing cerebrovascular stent placement do not respond well to clopidogrel

The importance of platelet inhibition in the prevention of in-stent thrombosis and re-stenosis, there is a great incentive to ensure that adequate antiplatelet effects are achieved in high-risk patients," said Dr.Prabhakaran, stroke neurologist at Rush University Medical Center.The study reviewed 76 patients who underwent cerebrovascular stent placement for various clinical indications, including wide-neck aneurysm and intracranial stenosis.Used the VerifyNow rapid platelet function assay-aspirin (RPFA-ASA) to calculate aspirin reaction units and the P2Y12 assay (VerifyNow) to calculate P2Y12 reaction units and percentage platelet inhibition immediately before the endovascular procedure.In the 71 patients on aspirin in whom ARU was measured, only three patients had a low response to aspirin.The 55 patients in whom percentage platelet inhibition was measured, 28 patients (50.Clopidogrel resistance.Researchers observed a significant association between older age (over the age of 55) and clopidogrel resistance and there was a strong effect of diabetes on platelet activity suggesting that these patients may require alternate approaches."Our study shows that using a point-of-care platelet function test in patients undergoing cerebrovascular stent placement is feasible and may be a valuable tool in the prevention of stent-relatedplications," said Prabhakaran.To the international normalized ratio used for warfarin, platelet function tests provide objective measurement of antiplatelet efficacy and help tailor therapy on an individual basis.These preliminary results, the researchers encourage further studies on ideal doses, timing, and duration of antiplatelet therapy for cerebrovascular stent placement.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 medical news service in accordance with these .Please note that medical information 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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Blood pressure drug 'cuts parkinson's risk' according to new research

He tells his story Victoria Beckham turned up for fashion week but sadly for her it wasn't what she was wearing that sparked all the gossip In a rare interview, Isla Fisher, the diminutive star of this week's hit romanticedy, reveals the ups and downs of life as 'Mrs Borat' As the nation debates the merits of Penny's new short hair, she remembers the bewildering array of styles she's had over the years.How some reduced her to tears Jennifer Lopez was in full bloom at the Unicef benefit hosted by Madonna at the United Nations HQ in New York last night Sarah Harding and Gemma Atkinson will send temperatures rising with their latest Ultimo ad Angelina Jolie flew into Baghdad on a UN goodwill mission today and left Brad Pitt holding all the babies 8 Mile actress Brittany Murphy sparked rumours of cosmetic surgery at a New York fashion week event with her plump lips The WAGS-in-chief continue to show off the fabulous figures They may have split.But the sight of Nancy Dell'Olio dressed up for a fashion shoot will give him palpitations The pop princess reprised her curly bob for an outing to Berlin where she was named best international act Britney Spears was today reunited with Adnan but her parents fear for her safety Hollyoaks' Summer Strallen has revealed how she had to double audition as TV actress and West End hopeful Kirsten Dunst has checked into a rehab centre in Utah after a week of partying at the Sundance Festival, a magazine claims Former soap star and Strictlye Dancing champion Jill Halfpenny is expecting a baby in May MP Stephen Pound dresses up as the third Cheeky girl.So much for the dignity of Parliament then!
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Joslin study identifies key factor that links metabolic syndrome; finding may help millions at high risk of cardiovascular disease

Represents the work of Sudha Biddinger, M.Ph.And a team led by C.Kahn, M.Head of the Joslin Research Section on Obesity and Hormone Action and the Mary K.Professor of Medicine at Harvard Medical School.Is one of the first true insights into the role of the liver in the metabolic syndrome and provides guidance for future therapies," said senior investigator Dr.An internationally recognized researcher in diabetes and metabolism.This connection between atherosclerosis and insulin resistance is one of the most dramatic findings I've seen in 35 years.Syndrome is a collection of medical problems related to insulin resistance, including obesity, glucose intolerance, hypertension, lowered HDL ("good") cholesterol and elevated triglycerides.These are associated with an increased risk of atherosclerosis, the buildup of plaque in the coronary arteries that leads to heart attack and stroke.Study clearly indicates that metabolic syndrome is not merely a collection of abnormalities that should be considered and treated independently, as some experts have advocated," said Kahn and Biddinger.It appears that metabolic syndrome is truly a group of closely linked disturbances in glucose and cholesterol metabolism that stem from a defect in insulin signaling in the liver.Research was funded in part by grants from the National Institutes of Health and The Iacocca Foundation.Center is the world's largest diabetes clinic, diabetes research center and provider of diabetes education.Diabetes Center HOW INTERESTING WAS THIS ARTICLE?Not Very.
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Nightly nicotine withdrawal in smokers may contribute to restless sleep

Speculate that the stimulating effects of nicotine could cause smokers to experience nicotine withdrawal each night, which may contribute to disturbances in sleep."It is possible that smoking has time-dependent effects across the sleep period," said study author Naresh M.MD, PhD, FCCP, Johns Hopkins University School of Medicine, Baltimore, MD.Difficulty falling asleep due to the stimulating effects of nicotine.Night evolves, withdrawal from nicotine may further contribute to sleep disturbance.Dr.And colleagues from Johns Hopkins University School of Medicinepared the sleep architecture of 40 smokers with that of a matched group of 40 nonsmokers, all of whom underwent home polysomnography.Smokers and nonsmokers have primarily used subjective measures of sleep; what makes this recent study unique is the study population, the use of objective measure of sleep, and the quantitative nature of the analysis.Most studies on sleepparing smokers and nonsmokers, Dr.Study included smoking and nonsmoking subjects who were free of most medicalorbidities and medication use."Finding smokers with no health conditions was challenging.In order to isolate the effects of smoking on sleep architecture, we needed to remove all factors that could potentially affect sleep, in particular, coexisting medical conditions," said Dr."In the absence of several medical conditions, sleep abnormalities in smokers could then be directly associated with cigarette use.An additional strength of this study was that sleep architecture was analyzed using both the conventional method of visual classification of electroencephalogram (EEG) patterns and through power spectral analysis of the EEG, which relies on a mathematical analysis of different frequencies contained within the sleep EEG.Sleep studies have relied on visual scoring of sleep stages, which is time-consuming and subject to misclassification," said Dr."Spectral analysis allows us to more objectively classify the sleep EEG signals and helps detect subtle changes that may have been overlooked with visual scoring.Visual scoring of sleep staging showed similar results between smokers and nonsmokers.Analysis showed that smokers had a lower percentage of delta power, or deep sleep, and a higher percentage of alpha power, or light sleep.Asked about sleep quality, 22.Of smokers reported lack of restful sleeppared with 5.Of nonsmokers.Also showed that the largest difference in sleep architecture occurred at the onset of sleep, which supports the premise that nicotine's effects are strongest in the early stages of sleep and potentially decrease throughout the sleep cycle.Researchers speculate the results of their study may have significant future implications in the area of smoking cessation."Many smokers have difficulty with smoking cessation partly because of the sleep disturbances as a result of nicotine withdrawal," said Dr."By understanding the temporal effects of nicotine on sleep, we may be able to better tailor nicotine replacement to minimize the withdrawal effects that smokers experience, particularly during sleep.Reported more caffeine use than nonsmokers.Caffeine consumption was not associated with the results of the EEG spectral analysis or lack of restful sleep."The long-term effects of smoking on respiratory and cardiovascular health are well-known," said Alvin V.Jr.FCCP, and President of the ACCP.This study is significant because it suggests that smokers may also be deprived of the much-needed restorative effects of sleep.Study provides yet one more reason to stop smoking or to never start. _Article adapted by Medical News Today from original press release.ACCP represents 17,000 members who provide patient care in the areas of pulmonary, critical care, and sleep medicine in the United States and throughout the world.ACCP's mission is to promote the prevention and treatment of diseases of the chest through leadership, education, research, andmunication.More information about the ACCP, please visit the ACCP Web site at .Source: Jennifer Stawarz HOW INTERESTING WAS THIS ARTICLE?Not Very.= Very) 1 2 3 4 5 I AM A: Please Select Healthcare Professional Member of the Public VISITOR RATINGS: Healthcare Professional:4.
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Effects and interactions in an environmentally relevant mixture of pharmaceuticals

TOXSCI ADVANCE ACCESS ORIGINALLY PUBLISHED ONLINE ON NOVEMBER 28, 2007 Toxicological Sciences 2008 102(1):129-137; doi:10.This Article All Versions of this Article: 102/1/129 _most recent_ Services Google Scholar PubMed EFFECTS AND INTERACTIONS IN AN ENVIRONMENTALLY RELEVANT MIXTURE OF PHARMACEUTICALS FRANCESCO POMATI,1, CHIARA ORLANDI, MOIRA CLERICI, FABIO LUCIANI AND ETTORE ZUCCATO _School of Biotechnology and Biomolecular Sciences, The University of New South Wales, Sydney 2052, Australia_ Department of Clinical and Biological Sciences, University of Insubria, Varese 21100, Italy Department of Biomedical, Experimental and Clinical Sciences, University of Insubria, Varese 21100, Italy Department of Environmental Health Sciences, "Mario Negri" Institute for Pharmacological Research, Milan 20157, Italy 1 To whom correspondence should be addressed.+612 9385 1591.Edu.Received October 9, 2007; accepted November 26, 2007 ABSTRACT With the goal of assessing the environmental risk of pharmaceuticals, we have previously observed that a mixture of 13 different drugs at environmentally relevant concentrations had adverse consequences on human and zebra fish cells _in vitro_.We aimed to identify both main and interaction effects within the same environmentally relevant mixture of pharmaceuticals.Studied _in vitro_ cytotoxicity in _Escherichia coli_, human embryonic HEK293, and estrogen-responsive OVCAR3 tumor cells using fractional-factorial experimental design.Approach identified a subset ofpounds of primary environmental concern, namely atenolol, bezafibrate, ciprofloxacin, and liycin, that had statistically significant effects on prokaryotic and eukaryotic cells at environmentally relevant exposure levels (ng/l).Could interact and behave as chemosensitizers, with joint effects representing a statistically significant element of mixture toxicity.And interactions were concentration dependent, confirming the difficulty of dose extrapolation in mixture toxicity data.Study suggests that a thorough investigation of mixture effects can direct environmental concerns toward a handful of pharmaceuticals, which may represent an actual risk at environmental concentrations.Indicate that risk identification may strongly depend on the use of environmentally relevant exposure scenarios.Interactions and dose dependency of effects may hamper the modeling and prediction of mixture toxicity with pharmaceuticals.Identification for micropollutants depends heavily on appropriate study designs, and we indicate the use of _in vitro_ cytotoxicity threshold and statistical design of experiments (DOEs) as a valid approach._Key Words:_ _E.HEK293; interaction; mixtures; OVCAR3; pharmaceuticals.
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Fda approves asmanex) twisthaler (mometasone furoate inhalation powder) for the once daily maintenance treatment of asthma in children ages 4-11

And Drug Administration (FDA) has approved Asmanex Twisthaler 110 mcg (mometasone furoate inhalation powder) for the maintenance treatment of asthma as a preventive therapy in patients 4 to 11 years of age.An inhaled corticosteroid (ICS).220 mcg was approved on March 31, 2005 by the FDA for maintenance treatment of asthma as preventive therapy in patients 12 years of age and older.Asthma is the mostmon chronic condition among children, and it is the cause of almost three million physician visits and 200,000 hospitalizations among children each year.Every day, maintenance inhalers help prevent asthma symptoms."As the first inhaled corticosteroid that is approved for once-daily dosing in children as young as age four, the approval of the pediatric indication for Asmanex provides an important treatment option for children with moderate and mild persistent asthma," said Robert J., chief medical officer and senior vice president, Schering-Plough Research Institute.According to updated guidelines from the National Asthma Education and Prevention Program, inhaled corticosteroids are the preferred foundation therapy for initiating long-term control in children with persistent asthma.Use of Asmanex helps manage asthma symptoms in patients with persistent asthma.Its automatic dose counter helps patients track remaining doses.The FDA approval of Asmanex for pediatric use is based in part on results from a 12-week placebo-controlled trial of 296 patients 4 to 11 years of age who had been diagnosed with asthma for at least six months.Showed significant improvement in percent predicted FEV1 (forced expiratory volume in one second) in patients treated with Asmanex 110 mcg once-daily, in the evening,pared to placebo.This study, secondary endpoints of morning and evening peak expiratory flow and rescue medication use were supportive of the efficacy of Asmanex Twisthaler.Only rmended dose for children 4-11 is 110 mcg (1 puff) administered once daily in the evening.ABOUT PEDIATRIC ASTHMA Asthma is a chronic disorder characterized by inflammation of the air passages, resulting in the temporary narrowing of the airways that transport air from the nose and mouth to the lungs.Symptoms, such as coughing, wheezing, and shortness of breath, occur during the day and night, impacting multiple aspects of patients' lives.Can affect activities such as exercising or going to school.Symptoms interfere with patients' ability to sleep.Affects more than one in every 20 children, and it is the third leading cause of hospitalization among children under the age of 15.Is also the mostmon cause of school absenteeism due to chronic disease, and it accounts for an annual loss of more than 14 million school days per year.Estimated cost of treating asthma in those younger than 18 years of age is $3.Per year.ABOUT ASMANEX(4) Asmanex was discovered and developed by Schering-Plough Research Institute and is currently approved for asthma treatment in more than 40 countries.Offers an effective inhaled corticosteroid to help manage asthma symptoms in a device that was awarded the DuPont Award for innovation in packaging.Asmanex Twisthaler employs an inhalation-driven device that does not use a propellant, thus eliminating the need for hand-breath coordination, and it provides patients with a numeric dose counter that provides a visual indication of the remaining doses.Asmanex is indicated for the maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older.Is not indicated for the relief of acute bronchospasm or in children less than 4 years of age.Asmanex Twisthaler therapy should not be used to treat sudden asthma attacks.Acting inhaler is still needed to relieve sudden asthma symptoms.Should be careful while adjusting to a switch from an oral steroid to the inhaled steroid Asmanex.Should be followed closely by their doctor.Can occur.Should tell their doctor right away about any symptoms such as feeling tired or exhausted, weakness, nausea, vomiting or symptoms of low blood pressure (such as dizziness or faintness).A patient is under stress, such as with surgery, after surgery or trauma, they may need steroids by mouth again.Inhaled steroids including Asmanex Twisthaler may cause a reduction in growth velocity when administered to pediatric patients.Long-term effect on final adult height is unknown.Should closely follow the growth of children and adolescents taking corticosteroids by any route.Patients who use inhaled steroid medicines for asthma may develop a fungal infection of the mouth.Should rinse their mouth after using Asmanex.Should contact their health care provider if they have or had tuberculosis, are exposed to chickenpox or measles, or about any other infections they had before or while using Asmanex.If a patient is at an increased risk for decreased bone mineral density, the use of corticosteroids may increase their risk.Health care provider should monitor their condition and, if needed, provide treatment.Use of inhaled corticosteroids, such as Asmanex, may increase the risk of some eye problems such as cataracts or glaa.Use Asmanex as directed by your health care provider, since its ability to work in your lungs depends on regular use.A patient's asthma symptoms do not improve, or get worse, they should contact their health care provider.The mostmon side effects with Asmanex Twisthaler include headache, nasal allergy symptoms, sore throat, upper respiratory infection, sinus infection, fungal infections of the mouth, painful menstrual periods, muscle and bone pain, back pain, and upset stomach.Full prescribing information is available at: http://www. ABOUT SCHERING-PLOUGH CORPORATION Schering-Plough is an innovation-driven, science-centered global health carepany.Own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world.Applies its research-and-development platform to human prescription and consumer products as well as to animal health products.November 2007, Schering-Plough acquired Organon BioSciences, with its Organon human health and Intervet animal health businesses, marking a pivotal step in thepany's ongoing transformation.Vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its approximately 50,000 people around the world.Is based in Kenilworth, N.And its Web site is www._SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential market for Asmanex.Relate to expectations or forecasts of future events.Does not assume the obligation to update any forward-looking statement.Could cause actual results to differ materially from Schering-Plough's forward-looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counterpetition, the regulatory process, and any developments following regulatory approval, among other uncertainties.Further details about these and other factors that may impact the forward-looking statements, see Schering-Plough's Securities and Exchangemission filings, including Part II, Item 1A.Factors" in Schering-Plough's third quarter 2007 10-Q.References: (1) "Asthma Facts and Figures.And Asthma Foundation of America, 2005.Cfm?"Tips to Remember: Childhood Asthma.Academy of Allergy Asthma & Immunology, May 2007.Stm (3) "National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma.Of Health.Heart Lung and Blood Institute, 2007.Gov/guidelines/asthma/asthgdln.Asmanex Twisthaler .NJ: Schering Corporation.(5) "What is Asthma?Heart Lung and Blood Institute, May 2006.Gov/health/dci/Diseases/Asthma/Asthma_WhatIs.An eMedicine manuscript by Michael J.MD, Assistant Chief, Clinical Investigation, Dept.Medicine, Brooke Army Medical Hospital, updated February 9, 2005, (accessed Tuesday, March 8, 2005)."Epidemiology of Nocturnal Asthma," Margaret Turner Warwick, DM, Ph.FRCP.American Journal of Medicine, July 29, 1988." method="get" action="" onsubmit="return false"> All Services Recent Searches Recently Approved Join Drugs to see what benefits you can get by joining our .The most popular,prehensive, and up-to-date source of drug information online.Advice on more than 24,000 prescription drugs and over-the-counter medicines for consumers and professionals .Top 10 Searches In The Pipeline - - - - - - - - - - - The drugs drug database is powered by MicromedexTM, Facts &parisonsTM and MultumTM.Data last updated 8 January 2008.
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Dcep chemotherapy followed by a single, fixed dose of pegylated filgrastim allows adequate stem cell mobilization in multiple myeloma patients

1537-2995. Abstract TRANSPLANTATION AND CELLULAR ENGINEERING DCEP CHEMOTHERAPY FOLLOWED BY A SINGLE, FIXED DOSE OF PEGYLATED FILGRASTIM ALLOWS ADEQUATE STEM CELL MOBILIZATION IN MULTIPLE MYELOMA PATIENTS Patrizia Zappasodi, Anna Maria Nosari, Cesare Astori, Dennis Ciapanna, Maurizio Bonfichi, Marzia Varettoni, Silvia Mangiacavalli, Enrica Morra, Mario Lazzarino, and Alessandro Corso From the Division of Hematology, Foundation IRCCS Policlinico S.Of Pavia, Pavia; and the Division of Hematology, Niguarda Ca' Granda Hospital, Milan, Italy.Patrizia Zappasodi, MD, Division of Hematology, Foundation, IRCCS Policlinico San Matteo, Via Golgi 2, 27100 Pavia, Italy; e-mail: .The authors state that they had no conflicts of interest and no industry support for the conduct and publication of this study.ABSTRACT BACKGROUND: Pegylated filgrastim (PEG-f), a long-lasting granulocyte-colony-stimulating factor, has been used in different hematologic conditions to shorten chemotherapy-induced neutropenia and to mobilize peripheral blood stem cells.On mobilization efficacy in patients with multiple myeloma are, however, still limited.STUDY DESIGN AND METHODS: The feasibility and mobilizing capacity of DCEP chemotherapy followed by a single subcutaneous dose of 6 mg of PEG-f in 23 myeloma patients (11 females and 12 males) whose median age was 55 years (range, 31-67 years) were investigated.RESULTS: The median number of CD34+ cells collected was 5.Per kg body weight with a range between 0 106 and 29.Per kg body weight.Patients (87%) yielded more than 2 106 per kg body weight CD34+ cells.The 22 patients who mobilized some CD34+ cells, 27 leukapheresis procedures were carried out (a single leukapheresis procedure in 17 patients and 2 leukapheresis procedures in 5).Median interval between the start of chemotherapy and the first leukapheresis procedure was 12 days (range, 11-16 days).To tolerability, 7 patientsplained of mild to moderate back pain, controlled with oral analgesics.Patient was hospitalized, and no fever or infections occurred.
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Long-term prognosis of henoch-schonlein nephritis in children

Supplement January 2008, pp.(doi:10.This Article Services Citing Articles Google Scholar PubMed NEPHROLOGY LONG-TERM PROGNOSIS OF HENOCH-SCHNLEIN NEPHRITIS IN CHILDREN AYSE ONERA, ZLEM ERDOGANB, TUBA ERENB, GLAY DEMIRCINB, MEHMET BLBLB, SAHIKA BAYSUNB AND NILUFER ARDAB a Pediatric Nephrology Department, Trakya University Medicine Faculty Hospital, Edirne, Turkey b Pediatric Nephrology Department, Dr Sami Ulus Children's Hospital, Ankara, Turkey ABSTRACT INTRODUCTION: The long-term prognosis in Henoch-Schnlein purpura is determined principally by the development of progressive glomerulonephritis (>10% progress to end-stage renal failure).OBJECTIVE: In this study we aimed to investigate the long-term prognosis of Henoch-Schnlein nephritis (HSN) in childhood.Between 1991 and 2003, 156 patients with HSN were investigated retrospectively.RESULTS: There were 86 boys and 70 girls with a mean age of 9.They were graded according to the degree of renal involvement: grade 1, isolated microscopic hematuria (_n_ = 31); grade 2, hematuria and mild proteinuria (_n_ = 60); grade 3, acute nephritic syndrome (_n_ = 4); grade 4, nephrotic syndrome hematuria (_n_ = 18); grade 5, acute nephritic and nephrotic syndrome (_n_ = 43).
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Intensive insulin therapy protects kidneys in critically ill patients

Also:_ REFERENCE The new research builds on previous randomized trials, including more than 2,700 patients, which reached the "startling" conclusion that IIT reduces the risk of death in critically ill patients, according to lead author Dr.Schetz of University of Leuven, Belgium.Those studies, one group of patients received IIT, with insulin given continuously to maintain normal glucose levels.Other group received conventional insulin therapy, in which blood glucose levels are allowed to rise above normal.Schetz and colleagues re-analyzed the trial data, focusing on differences in the rates of acute kidney injury (AKI) between the two treatment groups.Kidney injury is amon and seriousplication among patients admitted to the intensive care unit (ICU).Occurs in five to 30 percent of patients, with death rates exceeding 40 percent.Showed that AKI developed in 4.Of patients assigned to IIT,pared to 7.Of those receiving conventional insulin therapy.Reduction in AKI was greatest when glucose levels remained within the normal range.Intensive insulin therapy was more effective in protecting against AKI in patients admitted to the ICU after surgery (surgical ICU),pared to critically ill patients who did not undergo surgery (medical ICU).Can be explained by the fact that IIT is a preventive strategy that cannot heal damage that is already present," explains Dr."The medical ICU patients were much sicker to begin with and may have already had kidney damage.For many years, the medicalmunity has considered high blood sugar levels in critically ill patientscalled "stress diabetes"as a beneficial reaction of the body to ensure adequate energy supply to the organs during severe illness.New research grew out of studies led by Dr.Van den Berghe, exploring the hormonal changes induced by critical illness.Trials found that strict glucose control with IIT reduced the risk of death in both surgical and medical ICU patients.Of organ failure were also lower with IITpared to conventional insulin therapy.Van den Berghe is a co-author of the new study.The new analysis builds on these results by confirming that IIT reduces the risk of AKI in critically ill patients, especially after surgery.Finding is especially important, because intensive insulin therapy is the first medical treatment that has been clearly shown to protect the kidney of critically ill patients," Dr. More research is needed to clarify how IIT acts to protect the kidneyswhether by preventing direct kidney damage caused by high blood sugar, or through indirect effects.Of the mechanism, Dr.Concludes, "Since AKI is associated with increased morbidity and mortality, the goal should be to prevent its development.Dr.Berghe via the Catholic University of Leuven received an unrestricted research grant from Novo Nordisk._Adapted from materials provided by _.Need to cite this story in your essay, paper, or report?One of the following formats: APA MLA RELATED STORIES (Sep.2006) Diabetes puts people at risk of developing critical illness and dying early, but obesity without diabetes does not.Study published today in the open access journal Critical Care reveals that .> (Jun.2007) A simple laboratory test to measure protein Ca natural anti-blood-clotting substance that also reflects the level of inflammation in the bodymay offer a useful new indicator of the severity of .> (Feb.2007) Changing how critically ill patients are treated with hydrocortisone could reduce hyperglycemia.Results of a randomized controlled clinical trial, published today in the journal Critical Care, .> (Dec.2003) A study in the December issue of Mayo Clinic Proceedings on blood-sugar levels in 1,826 intensive care unit patients showed that hyperglycemia (high blood-sugar levels) increased the patients .> (Dec.2007) Increasing numbers of critically ill patients develop fungal or yeast infections, which are associated with high mortality.Reviewpares treatments involving single-drug antifungal .> _Number of stories in archives: 44,032_ _Find with keyword(s):_ Enter a keyword or phrase to search ScienceDaily's archives for related news topics, the latest news stories, reference articles, science videos, images, and books.IN: Some diabetes patients who cannot live without insulin injections now have a new option: a transplant of islet cells, which produce insulin in the.._.From _ __ IN OTHER NEWS . __ _.From _ Get the latest science news with our free email newsletters, updated daily and weekly.View hourly updated newsfeeds in your RSS reader: FEEDBACK _.We want to hear from you!Tell us what you think of the new ScienceDaily we wee both positive and negativements.
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Maternal obesity at conception programs obesity in the offspring

Published November 21, 2007; doi:10. 0363-6119/08 $8.All Versions of this Article: 294/2/R528 _most recent_ Services Google Scholar PubMed DEVELOPMENTAL PHYSIOLOGY AND PREGNANCY MATERNAL OBESITY AT CONCEPTION PROGRAMS OBESITY IN THE OFFSPRING KARTIK SHANKAR,1,2 AMANDA HARRELL,1 XIAOLI LIU,1 JANET M.J.AND THOMAS M._ 1Arkansas Children's Nutrition Center, Little Rock; and Departments of 2Pharmacology and Toxicology, 3Physiology and Biophysics, and 4Pediatrics, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas _ Submitted 6 May 2007 ; accepted in final form 19 November 2007 Risk of obesity in adult life is subject to programming during gestation.Examine whether in utero exposure to maternal obesity increases the risk of obesity in offspring, we developed an overfeeding-based model of maternal obesity in rats utilizing intragastric feeding of diets via total enteral nutrition.Diets to adult female rats at 220 kcal/kg3/4 per day (15% excess calories/day)pared with 187 kcal/kg3/4 per day for 3 wk caused substantial increase in body weight gain, adiposity, serum insulin, leptin, and insulin resistance.Or obese female rats were mated with ad libitum AIN-93G-fed male rats.To obesity was ensured to be limited only to the maternal in utero environment by cross-fostering pups to lean dams having ad libitum access to AIN-93G diets throughout lactation.Of pups, birth weight, and size were not affected by maternal obesity.Offspring from each group were weaned at postnatal day (PND)21 to either AIN-93G diets or high-fat diets (45% fat calories).Weights of offspring from obese dams did not differ from offspring of lean dams when fed AIN-93G diets through PND130.
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Intensive insulin therapy protects kidneys in critically ill patients

New research builds on previous randomized trials, including more than 2,700 patients, which reached the "startling" conclusion that IIT reduces the risk of death in critically ill patients, according to lead author Dr.Schetz of University of Leuven, Belgium.Those studies, one group of patients received IIT, with insulin given continuously to maintain normal glucose levels.Other group received conventional insulin therapy, in which blood glucose levels are allowed to rise above normal.Dr.And colleagues re-analyzed the trial data, focusing on differences in the rates of acute kidney injury (AKI) between the two treatment groups.Kidney injury is amon and seriousplication among patients admitted to the intensive care unit (ICU).Occurs in five to 30 percent of patients, with death rates exceeding 40 percent.Showed that AKI developed in 4.Of patients assigned to IIT,pared to 7.Of those receiving conventional insulin therapy.Reduction in AKI was greatest when glucose levels remained within the normal range.Insulin therapy was more effective in protecting against AKI in patients admitted to the ICU after surgery (surgical ICU),pared to critically ill patients who did not undergo surgery (medical ICU).Can be explained by the fact that IIT is a preventive strategy that cannot heal damage that is already present," explains Dr."The medical ICU patients were much sicker to begin with and may have already had kidney damage.Many years, the medicalmunity has considered high blood sugar levels in critically ill patients-called "stress diabetes"-as a beneficial reaction of the body to ensure adequate energy supply to the organs during severe illness.Research grew out of studies led by Dr.Van den Berghe, exploring the hormonal changes induced by critical illness.Trials found that strict glucose control with IIT reduced the risk of death in both surgical and medical ICU patients.Of organ failure were also lower with IITpared to conventional insulin therapy.Van den Berghe is a co-author of the new study.The new analysis builds on these results by confirming that IIT reduces the risk of AKI in critically ill patients, especially after surgery.Finding is especially important, because intensive insulin therapy is the first medical treatment that has been clearly shown to protect the kidney of critically ill patients," Dr. More research is needed to clarify how IIT acts to protect the kidneys-whether by preventing direct kidney damage caused by high blood sugar, or through indirect effects.Of the mechanism, Dr.Concludes, "Since AKI is associated with increased morbidity and mortality, the goal should be to prevent its development.Dr.Berghe via the Catholic University of Leuven received an unrestricted research grant from Novo Nordisk.The ASN is a not-for-profit organization of 10,500 physicians and scientists dedicated to the study of nephrology andmitted to providing a forum for the promulgation of information regarding the latest research and clinical findings on kidney diseases.# # # Contact: Shari Leventhal: 202-416-0658, sleventhal@asn-online.RESULTS ARCHIVE 2008: 2007: 2006: MORE NEWS RESOURCES All Services Recent Searches Recently Approved Join Drugs to see what benefits you can get by joining our .The most popular,prehensive, and up-to-date source of drug information online.Advice on more than 24,000 prescription drugs and over-the-counter medicines for consumers and professionals .10 Searches In The Pipeline - - - - - - - - - - - The drugs drug database is powered by MicromedexTM, Facts &parisonsTM and MultumTM.Data last updated 8 January 2008.
Read more Amoxicillin and clavulanate potassium (amoxicillin and clavulanate potassium) tablet, film coated [lek pharmaceuticals inc.]
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Single genetic change blocks morphine dependency

Research was published online by _Current Biology_ and appears in the journal's print edition.Scientists were led by Jennifer Whistler, PhD, an investigator in the UCSF-affiliated Ernest Gallo Clinic and Research Center, and associate professor of neurology at UCSF.Millions of people in the U.Are given the opiate drug morphine for extreme pain caused by cancer, surgery, nerve damage and other conditions.Remains the pain killer of choice for many types of short-term pain, such as surgery, according to Whistler, but it is less useful for the treatment of chronic pain because its effectiveness decreases with continued use in a process called tolerance.A consequence, an increasingly larger dose is required to treat the pain, thereby increasing the chance of addiction.The body's natural pain killers, such as endorphins, ease pain by first binding to receptors on the surface of neurons.Receptors cycle on and off "like a light switch," Whistler says, regulating the intake of endorphin.Crucial control is absent when the neurons encounter morphine.Researchers' strategy in their study was to try to trick neurons into responding to morphine in the more regulated way.Strong evidence suggests that the natural on-off cycling occurs because the endorphin receptor withdraws from the cell surface, toward the cell's interior, Whistler says.Migration from the cell surface is called endocytosis.When the neuron receptors encounter morphine the light switch is broken, and the nervous system responds by bing more tolerant of the drug, making the recipient more dependent on the drug.Demonstrate their hunch that morphine's unwanted effects were caused by the failure of its receptor to withdraw from the cell surface, the researchers genetically engineered mice with a single difference from normal mice: Receptors that encounter morphine in these mice can undergo endocytosis, as they normally do in the presence of endorphins.Researchers showed that with this single change, morphine remained an excellent pain killer without inducing tolerance and dependence."As more pain medications are being removed from the market, new strategies to ovee chronic pain be crucial," Whistler says.New opiate drugs can be developed with morphine's pain killing properties but also with the ability to promote endocytosis, they could be less likely to cause the serious side effects of tolerance and dependence.Research is the first direct demonstration that this single cellular change can block the body's tendency to be tolerant of the drug, she points out.Several strategies are now being tested to counter morphine addiction, Whistler says.Include development of morphine derivatives such as oxycontin, that are delivered in a time released manner or only once they have been processed in the digestive system.Seek to develop morphine derivatives that target only certain opioid receptors but not others."The most promising aspect of these other approaches is that they have the potential to prevent or delay dependence and addiction to morphine, but few of them address the development of tolerance," Whistler said. _Article adapted by Medical News Today from original press release.Coauthors on the paper are Joseph Kim, PhD; Selena Bartlett, PhD; Li He, MD; Carsten K.Amy Chang, BS; Viktor Kharazai, PhD, Maria Waldhoer, PhD, Chrissi Oul, BS, and Stacy Taylor, BS, all at the Gallo Center.Also: Madeline Ferwerdal, BS, and Dragana Cado, PhD, both at the Caner Research Laboratory, UC Berkeley.The research was supported by the National Institute of Drug Abuse and funds provided by the State of California for medical research on alcohol and substance abuse through UCSF.The Ernest Gallo Clinic and Research Center (Gallo Center) is one of world's preeminent academic centers for the study of the biological basis of alcohol and substance abuse.Center discoveries of potential molecular targets for the development of therapeutic medications are extended through preclinical and proof-of-concept clinical studies.UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate level education in the life sciences and health professions, and excellence in patient care.Source: Wallace Ravven HOW INTERESTING WAS THIS ARTICLE?Not Very.= Very) 1 2 3 4 5 I AM A: Please Select Healthcare Professional Member of the Public VISITOR RATINGS: Healthcare Professional:Not Yet Rated General Public: Not Yet Rated ADD TO: MOST POPULAR ARTICLES FROM THE LAST 7 DAYS 28 Jan 2008 22 Jan 2008 26 Jan 2008 22 Jan 2008 28 Jan 2008 - - Go back to - - View - Back to - Subscribe to our - Worldwide 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 Sections Menu Navigation Links Health Professional Sites Patient Resource Sites Clinical Trials Related Article Info NEWS FOR THIS CATEGORY 29 Jan 2008 29 Jan 2008 29 Jan 2008 VIDEOS FOR THIS CATEGORY Health Professionals '); 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Clinical trials with thiazolidinediones in subjects with type 2 diabetes – is pioglitazone any different from rosiglitazone?

Pages 405-420 (doi:10.405) Clinical trials with thiazolidinediones in subjects with Type 2 diabetes - is pioglitazone any different from rosiglitazone?Doggrell PhD DScRMIT University, Pharmaceutical Sciences, School of Medical Sciences, PO Box 71, Victoria 3083, Australia +61 3 99257161; +61 3 99257063; The thiazolidinediones, rosiglitazone and pioglitazone are used in the treatment of Type 2 diabetes (T2DM).Have been shown to decrease glycated haemoglobin levels, fasting plasma glucose, insulin, and free fatty acids levels in subjects with T2DM.These agents have markedly different effects on lipids.Increases total, low- and high-density lipoprotein (LDL and HDL) cholesterol, and triglycerides, whereas pioglitazone has no effect on total or LDL cholesterol, increases HDL cholesterol and decreases triglycerides.Rosiglitazone and pioglitazone decrease inflammatory markers.Both rosiglitazone and pioglitazone may cause a small decrease in blood pressure, improve endothelial function and reduce restenosis.Is also reduced by both rosiglitazone and pioglitazone.The improvements in surrogate end points, there is little clear evidence that either rosiglitazone or pioglitazone cause major improvements in cardiovascular oues.Rosiglitazone has no effect or may even increase cardiovascular oues, whereas, in high-risk subjects, pioglitazone has a marginal ability to decrease cardiovascular oues.Thiazolidinediones are shown to improve cardiovascular or other oues (e.
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Botox should carry stronger warning label, public-interest group says

> Medical News BOTOX SHOULD CARRY STRONGER WARNING LABEL, PUBLIC-INTEREST GROUP SAYS Public Citizen has asked the FDA to require stronger warnings for botulinum toxin (Botox and Myobloc), the _New York Times_ reports.On searching the FDA's adverse event database, Public Citizen found 180 manufacturer-submitted reports of dysphagia, aspiration, or pneumonia associated with Botox or Myobloc from 1997 through 2006.These patients, 16 died; most had received the drugs for muscle spasticity or unspecified reasons.One death involved wrinkle treatment, and Allergan, which makes Botox, says that death resulted from unrelated staphylococcus pneumonia.Adds that there's no proof of cause and effect in the other deaths.Public Citizen has asked the FDA to require Allergan and Solstice Neurosciences, which makes Myobloc, to write letters to doctors warning of possible hazards if botulinum toxin spreads from the injection site to other parts of the body.Group has also requested black-box warnings on the products' labels and MedGuides for patients.(One-time registration required) (Free) (Free) (Free PDF) (Free PDF) (Free PDF) _Published in_ Physician's First Watch _January 28, 2008_ SEARCH Enter keywords ARTICLE TOOLS SHARE SIGN-IN Username Password Remember Me NEW TO JOURNAL WATCH?2008.
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Recent studies of vytorin, avandia prompt debate about fda approval process for new medications

Bart Stupak (D-Mich.Thursday sent letters to the , the , Merck and Schering-Plough to request information about Vytorin, and Sen.Grassley (R-Iowa) on Thursday began a separate investigation into the medication.According to the Journal, the "lawmakers' interest is the latest sign that the flap over" Vytorin, as well as the safety concerns about Avandia, "is adding new fuel to a long-running debate" about the use of "surrogate markers" in the FDA approval process.Approved Vytorin and Avandia in large part based on evidence that they helped control cholesterol and blood sugar levels, respectively, with those measures "believed to reflect important clinical benefits" that "serve as proxy markers, or surrogates, for the drug's broader and more important effect on the body," the Journal reports.Use of surrogate markers helps reduce approval times for new medications because "studies can generally be shorter, smaller and cheaper," but the markers "can be misleading," according to the Journal.That, "in light of what's happened with Avandia and Vytorin, maybe the FDA needs to re-examine when it's appropriate to use surrogate endpoints.Added, "These two cases also highlight the importance of vigilant postmarketing surveillance and the need for more postmarketing studies to address important safety questions.That "people taking Vytorin are doing so because they believe it will reduce their risk of heart attack.Addition, he said, "It would make sense for FDA to require manufacturers to conduct an endpoint study to determine whether Vytorin just reduces cholesterol or if it also reduces heart attacks.Said that they would examine the use of surrogate markers in the agency approval process."shift by the FDA toward tougher scrutiny of new drugs could add hundreds of millions of dollars to the cost of developing a drug at a time when some big drug makers are struggling to replenish product pipelines," the Journal reports (Wilde Mathews/Winslow, Wall Street Journal, 1/25).Reprinted with kind permission from .Can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at .Kaiser Daily Health Policy Report is published for kaisernetwork.Free service of The Henry J.Family Foundation 2005 Advisory Boardpany and Kaiser Family Foundation.Rights reserved.HOW INTERESTING WAS THIS ARTICLE?Not Very.
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Metrogel(metronidazole) gel [galderma laboratories, l.p.]

A gel consisting of carbomer 940, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide.Is classified therapeutically as an antiprotozoal and antibacterial agent.Metronidazole is named 2-methyl-5-nitro-1H-imidazole-1-ethanol and has the following structure: CLINICAL PHARMACOLOGY Bioavailability studies on the topical administration of 1 gram of METROGEL(R) Topical Gel (7.Of metronidazole) to the face of 10 rosacea patients showed a maximum serum concentration of 66 nanograms per milliliter in one patient.Is approximately 100 times less than concentrations afforded by a single 250 mg oral tablet.Serum metronidazole concentrations were below the detectable limits of the assay at the majority of time points in all patients.Of the patients had no detectable serum concentrations of metronidazole at any time point.Dose of gel applied during clinical studies was 600 mg which represents 4.Of metronidazole per application.Under normal usage levels, the formulation affords minimal serum concentrations of metronidazole.By which METROGEL(R) (metronidazole topical gel) Topical Gel acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.INDICATIONS AND USAGE METROGEL(R) Topical Gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.CONTRAINDICATIONS METROGEL(R) Topical Gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.GENERAL METROGEL(R) Topical Gel has been reported to cause tearing of the eyes.Contact with the eyes should be avoided.A reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use.A nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia.INFORMATION FOR PATIENTS This medication is to be used as directed by the physician.Is for external use only.Contact with the eyes.INTERACTIONS Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time.Effect of topical metronidazole on prothrombin time is not known.CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters.Has shown evidence of mutagenic activity in several in vitro bacterial assay systems.Addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn's disease who were treated with 200-1200 mg/day of metronidazole for 1 to 24 months.No excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months.PREGNANCY TERATOGENIC EFFECTS Pregnancy category B: There has been no experience to date with the use of METROGEL(R) (metronidazole topical gel) Topical Gel in pregnant patients.The placental barrier and enters the fetal circulation rapidly.Fetotoxicity was observed after oral metronidazole in rats or mice.Because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used during pregnancy only if clearly needed.NURSING MOTHERS After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma.METROGEL(R) Topical Gel blood levels are significantly lower than those achieved after oral metronidazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.PEDIATRIC USE Safety and effectiveness in pediatric patients have not been established.ADVERSE REACTIONS The following adverse experiences have been reported with the topical use of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.DOSAGE AND ADMINISTRATION Apply and rub in a thin film of METROGEL(R) Topical Gel twice daily, morning and evening, to entire affected areas after washing.Areas to be treated should be cleansed before application of METROGEL(R) (metronidazole topical gel) Topical Gel.May use cosmetics after application of METROGEL(R) Topical Gel.HOW SUPPLIED METROGEL(R) (metronidazole topical gel) Topical Gel is supplied in a 45 g aluminum tube - NDC 0299-3835-45.Storage conditions: STORE AT CONTROLLED ROOM TEMPERATURE: 68 to 77F (20 to 25C).Marketed by: GALDERMA LABORATORIES, L.Fort Worth, Texas 76177 USA Manufactured by: DPT Laboratories, Ltd.Texas 78215 USA GALDERMA is a registered trademark.
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