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Abbott Receives FDA Approval for SIMCOR(R) (Niaspan(R) / simvastatin), a Novel Combination Medicine for Comprehensive Cholesterol Management
Date:2/15/2008

ended- 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 Indications

SIMCOR is the combination of two cholesterol-lowering medications: niacin extended-release (Niaspan(R)) 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 d
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