Simcor (Niaspan/simvastatin), the first fixed-dose combination of two widely prescribed cholesterol therapies, has been approved for use along with diet to lower levels of elevated total cholesterol, LDL cholesterol, and triglycerides, and to raise HDL cholesterol in patients with complex lipid disease when treatment with monotherapies are not considered adequate.
Abbott Laboratories of Abbott Park, Ill., Simcor’s manufacturer, developed the combo of
Niaspan (Abbott’s proprietary niacin extended-release) and simvastatin to target multiple lipids with one pill.
The approval was based on safety and efficacy trial data from more than 640 patients with mixed dyslipidemia and type II hyperlipidemia. In one clinical trial, patients receiving Simcor 1000/20 mg achieved significant cholesterol improvements over and above what simvastatin 20 mg alone provided, along with an additional reduction in triglycerides.
“With Simcor, doctors now have a new option for helping patients reach their LDL and HDL cholesterol treatment goals with a combination of two proven therapies,” said Eugene Sun, MD, vice president of Global Clinical Development for Abbott.