Abbott Park, IL - The US Food and Drug Administration has approved a fixed-dose combination of extended-release niacin (Niaspan, Abbot) and simvastatin for use in patients with complex lipid abnormalities where treatment with niacin or simvastatin alone is not sufficient.

The drug, known as Simcor (Abbott, Abbott Park, IL), is approved to lower total- and LDL-cholesterol levels and triglycerides and to raise HDL-cholesterol levels. The approval is based on safety and efficacy data from 640 patients with mixed dyslipidemia and type 2 dyslipidemia, a study in which patients treated with Simcor 1000/20 mg achieved significantly better improvements in cholesterol end points than simvastatin 20 mg. Also, compared with simvastatin 20 mg, the fixed-dose combination reduced triglyceride levels an additional 27%.

The drug was generally well tolerated, with flushing the most commonly reported side effect.

The US National Institutes of Health (NIH) is also sponsoring a trial that is evaluating the merits of simultaneously lowering LDL and raising HDL. The trial, known as Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides and Impact on Global Health Outcomes (AIM-HIGH), will compare the incidence of major cardiovascular events in patients randomized to niacin plus simvastatin or simvastatin alone.

The trial, which will enroll 3300 patients with established vascular disease, is run by Drs William Boden (Hartford Hospital, CT) and Greg Brown (University of Washington School of Medicine, Seattle), but full results are not expected until 2011. In addition to the NIH, Abbott is a cosponsor of the AIM-HIGH study.

The Clinical Trials Service Unit (CTSU) of Oxford University is also in on the HDL-cholesterol show. That group is running a study, known as Heart Protection Study 2 Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE), that will assess whether a new combination tablet, containing extended-release niacin and a specific blocker of prostaglandin D2 to prevent flushing, prevents MI, stroke, or revascularization procedures in patients with existing vascular disease.