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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

ie Ballantyne, M.D., Baylor College of Medicine and Methodist DeBakey Heart Center, Houston, Texas, and lead investigator on the study. "With the SEACOAST study, SIMCOR provided comparable LDL lowering to simvastatin with significant benefit in raising good cholesterol and lowering triglycerides. This type of combination approach could be an important tool in treating patients with complex lipid disorders."

About SEACOAST

This 24-week double-blind, randomized, controlled trial in more than 600 patients with elevated non-HDL (type II hyperlipidemia or mixed dyslipidemia) compared simvastatin alone to a combination of Abbott's extended-release niacin combined with simvastatin. The study was designed to evaluate the safety and efficacy of the SIMCOR combination following simvastatin monotherapy. Patients enrolled in the trial were assigned to either a low-dose (20 mg) or high-dose (40 mg) simvastatin group. Patients in the low-dose group were randomized to receive Niaspan 2000 mg/simvastatin 20 mg, Niaspan 1000 mg/simvastatin 20 mg, or simvastatin 20 mg. Patients in the high-dose group were randomized to receive Niaspan 2000 mg/simvastatin 40 mg, Niaspan 1000 mg/simvastatin 40 mg or simvastatin 80 mg. Those in the simvastatin control groups received a 50 mg dose of immediate-release niacin to maintain blinding.

Patients in the low-dose group receiving combination treatment achieved 14 percent (1000 mg/20 mg) and 23 percent (2000 mg/20 mg) reductions in non-HDL compared to a 7 percent reduction with 20 mg simvastatin therapy alone. Additionally, combination treatment resulted in significant improvements in HDL of 18 percent (1000 mg/20 mg) and 25 percent (2000 mg/20 mg) compared to 7 percent with 20 mg simvastatin alone. Similarly, significant reductions in triglycerides of 27 percent (1000 mg/20 mg) and 38 percent (2000 mg/20 mg) were seen in those treated with combination therapy compared to a 15 percent reduction with simvastatin monotherapy.


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SOURCE Abbott
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