ORLANDO, Fla., Nov. 4 New data released todayshowed that Abbott's SIMCOR(R), an investigational, fixed-dose combination ofAbbott's proprietary extended-release niacin, Niaspan(R), and simvastatin metits primary endpoint of lowering plaque-promoting non-HDL cholesterol (totalcholesterol minus HDL), while demonstrating improvements on other key lipids,LDL "bad" cholesterol, HDL "good" cholesterol and triglycerides. Results fromthis Phase III clinical trial, SEACOAST, were presented today as part of theAmerican Heart Association's Scientific Sessions.
Patients in the study treated with a SIMCOR combination containing 20 mgsimvastatin had significantly better reductions in non-HDL cholesterolcompared to 20 mg simvastatin therapy alone, as well as significantimprovements in HDL and triglyceride levels. Patients receiving a SIMCORcombination with 40 mg simvastatin experienced reductions in non-HDLcomparable to 80 mg simvastatin alone, and significantly better improvementsin HDL and triglycerides compared with 80 mg simvastatin alone. Flushing isthe most commonly reported side effect associated with Niaspan. It isgenerally mild and can be lessened by taking aspirin 30 minutes prior totaking the medication at bedtime. Six percent of patients on the combinationdiscontinued therapy due to flushing compared to 0.8 percent with simvastatinalone.
SIMCOR combines two well-established and leading medications, Niaspan andsimvastatin, to target multiple lipid parameters -- LDL, HDL and triglycerides-- in a single pill. Abbott submitted its New Drug Application to the Foodand Drug Administration for SIMCOR in April 2007. The submission includesdata from the Phase III pivotal SEACOAST trial.
"Patients know that it's important to manage the "bad" cholesterol, butit's essential to control HDL and triglyceride levels as well," said ChristieBallantyne, M.D., Baylor College of Medicine and Methodist DeBakey HeartCenter, Houston, Texas, and lead investigator on the study. "With theSEACOAST study, SIMCOR provided comparable LDL lowering to simvastatin withsignificant benefit in raising good cholesterol and lowering triglycerides.This type of combination approach could be an important tool in treatingpatients with complex lipid disorders."
This 24-week double-blind, randomized, controlled trial in more than 600patients with elevated non-HDL (type II hyperlipidemia or mixed dyslipidemia)compared simvastatin alone to a combination of Abbott's extended-releaseniacin combined with simvastatin. The study was designed to evaluate thesafety and efficacy of the SIMCOR combination following simvastatinmonotherapy. Patients enrolled in the trial were assigned to either alow-dose (20 mg) or high-dose (40 mg) simvastatin group. Patients in thelow-dose group were randomized to receive Niaspan 2000 mg/simvastatin 20 mg,Niaspan 1000 mg/simvastatin 20 mg, or simvastatin 20 mg. Patients in thehigh-dose group were randomized to receive Niaspan 2000 mg/simvastatin 40 mg,Niaspan 1000 mg/simvastatin 40 mg or simvastatin 80 mg. Those in thesimvastatin control groups received a 50 mg dose of immediate-release niacinto maintain blinding.
Patients in the low-dose group receiving combination treatment achieved 14percent (1000 mg/20 mg) and 23 percent (2000 mg/20 mg) reductions in non-HDLcompared to a 7 percent reduction with 20 mg simvastatin therapy alone.Additionally, combination treatment resulted in significant improvements inHDL of 18 percent (1000 mg/20 mg) and 25 percent (2000 mg/20 mg) compared to 7percent with 20 mg simvastatin alone. Similarly, significant reductions intriglycerides 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 percentreduction with simvastatin monotherapy.
In the high-dose group, patients treated with SIMCOR combination the