Patients treated with a new investigational combination pill showed significant improvements in cholesterol, triglycerides and other key lipids that lead to heart disease, according to results presented at the American Heart Association's Scientific Sessions.
Simcor combines prescription niacin and simvastatin, two FDA-approved medications with established safety profiles, to target good cholesterol (HDL), bad cholesterol (LDL), and triglycerides in a single pill.
“These results indicate that Simcor can go beyond what simvastatin alone can provide,” said principal investigator Dr. Christie Ballantyne, medical director of the Center for Cardiovascular Disease Prevention at the Methodist DeBakey Heart Center in Houston. “This type of combination approach could be an important tool in treating the increasing number of patients with complex lipid disorders, the metabolic syndrome and heart disease.”
Treatment of high cholesterol has historically centered on the use of statins, including simvastatin, to lower LDL cholesterol, which has been the primary target of therapy.
“We now place more importance on comprehensive cholesterol management, including management of HDL levels, in impacting cardiovascular risk,” Ballantyne said. “Medications like Simcor can help patients address multiple problems with one pill.”
Abbott's Simcor, an investigational, fixed-dose combination of Niaspan®, Abbott's extended-release niacin, and simvastatin, met its primary endpoint of lowering non-HDL cholesterol and demonstrating improvements on LDL, HDL and triglycerides. Niacin is known to raise HDL and statins are known to reduce LDL cholesterol and triglycerides.
Research was conducted at the Methodist DeBakey Heart Center and other sites across the nation. Patients in the study treated with a Simcor combination containing 20 mg simvastatin had significantly better reductions in non-HDL (total cholesterol minus HDL) 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 high-dose simvastatin alone, and significant improvements in HDL and triglycerides.
In April, Abbott submitted its New Drug Application to the Food and Drug Administration for Simcor including includes data from this Phase III pivotal SEACOAST trial.
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 SEACOAST 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.