NIH backs study of good/bad cholesterol combination treatmentThe National Institutes of Health has agreed to fund a large clinical test to determine whether raising good cholesterol with a niacin-based drug, while lowering bad cholesterol with a statin, can prevent more heart disease than a statin alone, The Wall Street Journal reported today.
Previous small clinical tests have indicated that high levels of good cholesterol, or HDL cholesterol, can provide additional levels of protection. The theory has fueled development of drugs to raise HDL levels. Pfizer is spending more than $600 million on clinical tests of a combination of its best-selling blockbuster Lipitor and torcetrapib, an experimental drug to raise HDL levels.
The six-year study is expected to involve 3,300 patients, with about a third of them women. To qualify, the subjects must have existing cardiovascular disease and be candidates for drug therapy. Patients will receive either simvastatin, the generic name for Merck's Zocor, or simvastatin plus Niaspan, an extended-release form of niacin available by prescription from Kos Pharmaceuticals.
The NIH's National Heart, Lung and Blood Institute is expected to provide about $22 million in funding for the study and administer about $20 million in unrestricted funding from KOS. Some 50 to 60 clinical sites in the U.S. and Canada are expected to enroll patients in the study to begin in November.