FDA Approval For SIMCOR (Niaspan / Simvastatin), A Novel Combination Medicine For Comprehensive Cholesterol Management

Abbott received U.S. Food and Drug Administration (FDA) approval for SIMCOR, the first fixed-dose mixture of two recommended cholesterol therapies, Niaspan (Abbott’s proprietary niacin extended-release) and simvastatin. Christie Ballantyne, M.D., the Methodist DeBakey Vascular and Center, Houston, and lead SIMCOR investigator. Around 80 million Americans have high degrees of the bad LDL cholesterol, and more than 44 million have low levels of the good HDL cholesterol, that your body uses to eliminate 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 predicated on SIMCOR basic safety and effectiveness trial data from more than 640 patients with mixed dyslipidemia and type II hyperlipidemia. In the SEACOAST clinical trial, patients getting SIMCOR 1000/20mg achieved significant cholesterol improvements in addition to what simvastatin 20mg alone provided. SIMCOR was well tolerated by patients in medical studies generally. Six percent of patients discontinued therapy due to flushing, the most reported side-effect of SIMCOR and niacin-based remedies commonly. Flushing can be minimized by taking aspirin or an NSAID half an hour prior to taking the medication at bedtime. Flushing may subside over several weeks of consistent SIMCOR use. Eugene Sun, M.D., vice leader of Global Clinical Development for Abbott.

The American Heart Association, National Cholesterol Education Program (NCEP) and American College of Cardiology recommend more intense treatment of HDL lessen cardiovascular risk. Cholesterol and other lipids can build up in the bloodstream developing plaque and restrict blood circulation, which can result in heart disease. According to NCEP suggestions, a reduction in LDL of just one 1 percent is associated with a 1 percent decrease in heart disease risk. Additionally, increasing HDL by 1 point is associated with a 2 percent heart disease risk decrease. Abbott is focused on the continuing 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 ramifications of niacin extended- release and simvastatin in reducing cardiovascular events in patients with existing heart disease. SIMCOR is the combination of two cholesterol-lowering medications: niacin extended-release (Niaspan) and simvastatin. SIMCOR is utilized along with diet to lower degrees of total cholesterol, LDL “bad” cholesterol and triglycerides, and to increase HDL “good” cholesterol. SIMCOR is used when treatment with simvastatin niacin or monotherapy extended-release monotherapy is considered inadequate, so when diet and other non-drug procedures only have not been successful.

Patients should stay on a diet lower in saturated body fat and cholesterol while taking this medicine. No additional benefit of SIMCOR on heart disease over and above that shown for niacin only and simvastatin only has been proven. SIMCOR ought not to be utilized by people with liver problems, tummy ulcers, or serious bleeding problems; in women who are pregnant, may become pregnant, or nursing; and in people allergic to any product ingredient.

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Patients should contact their doctor if symptoms of unexplained muscle pain, tenderness, or weakness happen, as this may be an indicator of a serious but rare muscle disorder, from which rare circumstances of death have occurred. The health care provider should be educated about every other medications, vitamin supplements, or nutritional supplements people are taking to avoid possible serious drug interactions. SIMCOR ought never to be substituted for equal dosages 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 utilized with caution by patients who consume large amounts of alcohol. Health care providers may do simple blood lab tests before and during treatment with SIMCOR to check on for liver problems. SIMCOR may cause an increase in blood sugar. Patients with diabetes should report any changes in blood sugar to their doctor.

Women of childbearing age group should use a highly effective method of birth control to prevent being pregnant when using SIMCOR. Flushing (heat, redness, itching, and/or tingling of the skin) is the most common side effect and may become less frequent over time. Additional symptoms might include rapid or pronounced heartbeat, shortness of breath, sweating, chills, dizziness, fainting, and/or bloating. Flushing can vary greatly in severity and is more likely to occur when starting therapy or during dose increases. By firmly taking SIMCOR at bedtime, flushing shall 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 results may include headache, itching, nausea, back pain, and diarrhea. Available since 1997, Niaspan is the only FDA-approved, extended-release prescription formulation of niacin for dealing with irregular cholesterol levels once-daily.