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Abbott's Investigational SIMCOR(R) Offers Comparable LDL Lowering to Simvastatin and Significantly Raises HDL and Lowers Triglycerides in Phase III Study
Date:11/4/2007

Six Percent of Patients Discontinued Combination Therapy Due to Flushing

ORLANDO, Fla., Nov. 4 /PRNewswire-FirstCall/ -- New data released today showed that Abbott's SIMCOR(R), an investigational, fixed-dose combination of Abbott's proprietary extended-release niacin, Niaspan(R), and simvastatin met its primary endpoint of lowering plaque-promoting non-HDL cholesterol (total cholesterol minus HDL), while demonstrating improvements on other key lipids, LDL "bad" cholesterol, HDL "good" cholesterol and triglycerides. Results from this Phase III clinical trial, SEACOAST, were presented today as part of the American Heart Association's Scientific Sessions.

Patients in the study treated with a SIMCOR combination containing 20 mg simvastatin had significantly better reductions in non-HDL cholesterol compared to 20 mg simvastatin therapy alone, as well as significant improvements in HDL and triglyceride levels. Patients receiving a SIMCOR combination with 40 mg simvastatin experienced reductions in non-HDL comparable to 80 mg simvastatin alone, and significantly better improvements in HDL and triglycerides compared with 80 mg simvastatin alone. Flushing is the most commonly reported side effect associated with Niaspan. It is generally mild and can be lessened by taking aspirin 30 minutes prior to taking the medication at bedtime. Six percent of patients on the combination discontinued therapy due to flushing compared to 0.8 percent with simvastatin alone.

SIMCOR combines two well-established and leading medications, Niaspan and simvastatin, to target multiple lipid parameters -- LDL, HDL and triglycerides -- in a single pill. Abbott submitted its New Drug Application to the Food and Drug Administration for SIMCOR in April 2007. The submission includes data from the Phase III pivotal SEACOAST trial.

"Patients know that it's important to manage the "bad" cholesterol, but it's essential to control HDL and triglyceride levels as well," said Christ
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SOURCE Abbott
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