Abbott Receives FDA Approval for Simcor (Niaspan / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management
ABBOTT PARK, Ill., February 15, 2008 /PRNewswire-FirstCall/ -- Today, Abbott received U.S. Food and Drug Administration (FDA) approval for Simcor, the first fixed-dose combination of two widely prescribed cholesterol therapies, Niaspan (Abbott's proprietary niacin extended-release) and simvastatin. Simcor 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 with complex lipid disease when treatment with simvastatin or Niaspan monotherapies are not considered adequate.
"Managing cholesterol encompasses many factors, not just lowering LDL. There is a clear need for medicines that both raise good and comprehensively lower the bad components of cholesterol," said Christie Ballantyne, M.D., the Methodist DeBakey Heart and Vascular Center, Houston, and lead Simcor investigator. "Simcor represents an important new option to help patients reach healthy lipid levels."
An 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. Studies 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.
The FDA's approval was based on Simcor safety and efficacy trial data from more than 640 patients with mixed dyslipidemia and type II hyperlipidemia. In the SEACOAST clinical trial, patients receiving Simcor 1000/20mg achieved significant cholesterol improvements over and above what simvastatin 20mg alone provided. Patients 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 increase compared to a 7 percent decrease in LDL and an 8 percent increase in HDL with simvastatin 20mg alone. Furthermore, Simcor reduced triglycerides by an additional 27 percent compared to 15 percent with simvastatin 20mg alone.
Simcor was generally well tolerated by patients in clinical studies. Six percent of patients discontinued therapy due to flushing, the most commonly reported side effect of Simcor and niacin-based therapies. Flushing can be minimized by taking aspirin or an NSAID 30 minutes prior to taking the medication at bedtime. Flushing may subside over several weeks of consistent Simcor use.
"With Simcor, doctors now have a new option for helping patients reach their LDL and HDL cholesterol treatment goals with a combination of two proven therapies," said Eugene Sun, M.D., vice president of Global Clinical Development for Abbott. "Abbott is committed 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."
The American Heart Association, National Cholesterol Education Program (NCEP) and of Cardiology recommend more aggressive treatment of HDL to reduce cardiovascular risk. Cholesterol and other lipids can build up in the bloodstream forming plaque and restricting blood flow, which can lead to heart disease. According to NCEP guidelines, a reduction in LDL of 1 percent is associated with a 1 percent reduction in heart disease risk. Additionally, raising HDL by 1 point is associated with a 2 percent heart disease risk reduction.
Abbott is committed to the continued research of its products and has sponsored the National Heart Lung and Blood Institute's AIM-HIGH outcomes study. The study is designed to evaluate the effects of niacin extended- release and simvastatin in reducing cardiovascular events in patients with existing heart disease. AIM-HIGH began enrolling patients in 2005 with final results expected to be reported in 2011.
Simcor is the combination of two cholesterol-lowering medications: niacin extended-release (Niaspan) and simvastatin. Simcor is used along with diet to lower levels of total cholesterol, LDL "bad" cholesterol and triglycerides, and to increase HDL "good" cholesterol. Simcor is 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. Patients should stay on a diet low in saturated fat and cholesterol while taking this medicine. No additional benefit of Simcor on heart disease over and above that shown for niacin alone and simvastatin alone has been demonstrated.
Important 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 become pregnant, or nursing; and in people allergic to any product ingredient. Patients should 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. Health care provider should be informed about any other medications, vitamins, or nutritional supplements people are taking to avoid possible serious drug interactions. Simcor should not be substituted for equivalent doses of immediate-release niacin. Liver damage has been reported when substituting sustained-release niacin products with immediate-release niacin at equivalent doses. Always check with a health care provider before changing medication. Simcor should be used with caution by patients who consume large amounts of alcohol. Health care providers may do simple blood tests before and during treatment with Simcor to check for liver problems.
Simcor may cause an increase in blood sugar levels. Patients with diabetes should report any changes in blood sugar levels to their health care provider. Women of childbearing age should use an effective method of birth control to prevent pregnancy while using Simcor. Flushing (warmth, redness, itching, and/or tingling of the skin) is the most common side effect and may become less frequent over time. Additional symptoms may include rapid or pronounced heartbeat, shortness of breath, sweating, chills, dizziness, fainting, and/or swelling. Flushing may vary in severity and is more likely to occur when starting therapy or during dose increases. By taking Simcor at bedtime, flushing will most likely occur during sleep. If awakened by flushing, patients should take their time getting up, especially if feeling dizzy, faint, or taking blood pressure medications. Other common side effects may include headache, itching, nausea, back pain, and diarrhea. More information about Simcor, including full prescribing information, is available on the Web site http://www.rxabbott.com/pdf/simcor_pi.pdf, or by calling Abbott Medical Information at 1-800-633-9110.
Available since 1997, Niaspan is the only FDA-approved, once-daily extended-release prescription formulation of niacin for treating abnormal cholesterol levels.
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. In patients with a history of myocardial infarction and hypercholesterolemia, niacin is indicated to reduce the risk of recurrent non-fatal myocardial infarction. In patients with coronary artery disease and hypercholesterolemia, niacin, in combination with a bile acid binding resin, is indicated to slow progression or promote regression of atherosclerotic disease.
Important 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. Niaspan should not be substituted for equivalent doses of immediate-release niacin. Niaspan should be prescribed with caution in patients who consume substantial amounts of alcohol and/or have a past history of liver disease. Liver function tests should be performed on all patients during therapy with Niaspan. Use of Niaspan with other lipid-altering medications called statins may increase the risk of rhabdomyolysis, a rare condition that causes muscles to breakdown. The most common side effect with Niaspan is flushing of the skin. Patients with diabetes should carefully monitor their blood sugar and report changes to their doctor. Other commonly reported side effects include indigestion, headache, pain, abdominal pain, nausea, itching, diarrhea, runny nose, vomiting and rash. More information about Niaspan, including full prescribing information, is available on the Web site http://www.rxabbott.com/pdf/niaspan.pdf or by calling Abbott Medical Information at 1-800-633-9110.
Important 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 become pregnant, and anyone with liver problems. Unexplained 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. Simvastatin 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. Patients should tell their doctor about any other medications they are taking. The most common side effects are headache, abdominal pain, and constipation.
Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs 65,000 people and markets its products in more than 130 countries.
Abbott's news releases and other information are available on the company's Web site at http://www.abbott.com.
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Posted: February 2008
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