суббота, 1 марта 2008 г.

Abbott receives fda approval for simcor® (niaspan® / simvastatin), a novel combination medicine for comprehensive cholesterol management

Is approved for use along with diet to lower levels of elevated total cholesterol, LDL "bad" cholesterol and triglycerides, and to raise HDL "good" cholesterol in patients withplex lipid disease when treatment with simvastatin or Niaspan monotherapies are not considered adequate.Cholesterol epasses many factors, not just lowering LDL.A clear need for medicines that both raise good andprehensively lower the badponents of cholesterol," said Christie Ballantyne, M.Methodist DeBakey Heart and VascularCenter, Houston, and lead SIMCOR investigator.Represents an important new option to help patients reach healthy lipid levels.Estimated 80 million Americans have high levels of the bad LDL cholesterol, and more than 44 million have low levels of the good HDL cholesterol, which the body uses to remove bad cholesterol from the bloodstream.Have shown that along with diet, SIMCOR can help patients with lipid disorders reach their treatment goals by addressing more than just bad cholesterol, targeting multiple lipids with one pill.FDA's approval was based on SIMCOR safety and efficacy trial data from more than 640 patients with mixed dyslipidemia and type II hyperlipidemia.The SEACOAST clinical trial, patients receiving SIMCOR 1000/20mg achieved significant cholesterol improvements over and above what simvastatin 20mg alone provided.Treated with SIMCOR 1000/20mg had additional lipid improvements beyond simvastatin 20-mg treated baseline, with additional LDL reductions of 12 percent and an additional 21 percent HDL increasepared to a 7 percent decrease in LDL and an 8 percent increase in HDL with simvastatin 20mg alone.Triglycerides by an additional 27 percentpared to 15 percent with simvastatin 20mg alone.Was generally well tolerated by patients in clinical studies.Of patients discontinued therapy due to flushing, the mostmonly reported side effect of SIMCOR and niacin-based therapies.Be minimized by taking aspirin or an NSAID 30 minutes prior to taking the medication at bedtime.May subside over several weeks of consistent SIMCOR use.SIMCOR, doctors now have a new option for helping patients reach their LDL and HDL cholesterol treatment goals with abination of two proven therapies," said Eugene Sun, M.Vice president of Global Clinical Development for Abbott.Ismitted to bringing forward new cholesterol therapies, and SIMCOR represents a new treatment option for patients in Abbott's rapidly expanding portfolio of cholesterol treatments for lipid disorders.American Heart Association, National Cholesterol Education Program (NCEP) and American College of Cardiology rmend more aggressive treatment of HDL to reduce cardiovascular risk.And other lipids can build up in the bloodstream forming plaque and restricting blood flow, which can lead to heart disease.To NCEP guidelines, a reduction in LDL of 1 percent is associated with a 1 percent reduction in heart disease risk.Raising HDL by 1 point is associated with a 2 percent heart disease risk reduction.Ismitted to the continued research of its products and has sponsored the National Heart Lung and Blood Institute's AIM-HIGH oues study.Study is designed to evaluate the effects of niacin extended-release and simvastatin in reducing cardiovascular events in patients with existing heart disease.Began enrolling patients in 2005 with final results expected to be reported in 2011.INDICATIONS SIMCOR is thebination of two cholesterol-lowering medications: niacin extended-release (Niaspan(R)) and simvastatin.Is used along with diet to lower levels of total cholesterol, LDL "bad" cholesterol and triglycerides, and to increase HDL "good" cholesterol.Used when treatment with simvastatin monotherapy or niacin extended-release monotherapy is considered inadequate, and when diet and other non-drug measures alone have not been successful.Should stay on a diet low in saturated fat and cholesterol while taking this medicine.Benefit of SIMCOR on heart disease over and above that shown for niacin alone and simvastatin alone has been demonstrated.SAFETY INFORMATION ABOUT SIMCOR SIMCOR should not be used by people with liver problems, stomach ulcers, or serious bleeding problems; in women who are pregnant, may be pregnant, or nursing; and in people allergic to any product ingredient.Contact their health care provider if symptoms of unexplained muscle pain, tenderness, or weakness occur, as this may be a sign of a serious but rare muscle disorder, from which rare cases of death have occurred.Care provider should be informed about any other medications, vitamins, or nutritional supplements people are taking to avoid possible serious drug interactions.Should not be substituted for equivalent doses of immediate-release niacin.Has been reported when substituting sustained-release niacin products with immediate-release niacin at equivalent doses.With a health care provider before changing medication.Be used with caution by patients who consume large amounts of alcohol.Care providers may do simple blood tests before and during treatment with SIMCOR to check for liver problems.May cause an increase in blood sugar levels.With diabetes should report any changes in blood sugar levels to their health care provider.Of childbearing age should use an effective method of birth control to prevent pregnancy while using SIMCOR.Redness, itching, and/or tingling of the skin) is the mostmon side effect and may be less frequent over time.May include rapid or pronounced heartbeat, shortness of breath, sweating, chills, dizziness, fainting, and/or swelling.May vary in severity and is more likely to occur when starting therapy or during dose increases.Taking SIMCOR at bedtime, flushing will most likely occur during sleep.Awakened by flushing, patients should take their time getting up, especially if feeling dizzy, faint, or taking blood pressure medications.Side effects may include headache, itching, nausea, back pain, and diarrhea.NIASPAN Available since 1997, Niaspan is the only FDA-approved, once-daily extended-release prescription formulation of niacin for treating abnormal cholesterol levels.INDICATIONS Niaspan is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate, to reduce elevated total cholesterol, LDL-C, Apo B, and triglyceride levels, and to increase HDL-C in patients with primary hypercholesterolemia and mixed dyslipidemia.Patients with a history of myocardial infarction and hypercholesterolemia, niacin is indicated to reduce the risk of recurrent non-fatal myocardial infarction.With coronary artery disease and hypercholesterolemia, niacin, inbination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.Safety Information About Niaspan Niaspan is contraindicated in patients with allergies to any of its ingredients, active peptic ulcer disease, significant or unexplained persistent liver dysfunction, or arterial bleeding.Should not be substituted for equivalent doses of immediate-release niacin.Be prescribed with caution in patients who consume substantial amounts of alcohol and/or have a past history of liver disease.Function tests should be performed on all patients during therapy with Niaspan.Of Niaspan with other lipid-altering medications called statins may increase the risk of rhabdomyolysis, a rare condition that causes muscles to breakdown.Mostmon side effect with Niaspan is flushing of the skin.With diabetes should carefully monitor their blood sugar and report changes to their doctor.Side effects include indigestion, headache, pain, abdominal pain, nausea, itching, diarrhea, runny nose, vomiting and rash.SAFETY INFORMATION ABOUT SIMVASTATIN Simvastatin is a prescription tablet and isn't right for everyone, including women who are nursing or pregnant or who may be pregnant, and anyone with liver problems.Muscle pain or weakness could be a sign of rhabdomyolysis, a rare but serious side effect and should be reported to a doctor right away.May interact with certain foods or other medicines including lipid-lowering medications called fibrates or niacin, increasing the risk of getting this serious side effect.Should tell their doctor about any other medications they are taking.Mostmon side effects are headache, abdominal pain, and constipation.ABBOTT Abbott (NYSE: ABT) is a global, broad-based health carepany devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics.Employs 65,000 people and markets its products in more than 130 countries.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 11 Feb 2008 13 Feb 2008 13 Feb 2008 11 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