February 18, 2008 - Abbott received FDA approval for SIMCOR a fixed-dose combination of two cholesterol therapies, Niaspan (Abbott’s proprietary niacin extended-release) and simvastatin, offering patients a new option for reaching healthy lipid levels.
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.
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 the SEACOAST clinical trial, in which patients received 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.
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