20 nov 2009-- In patients at high risk of cardiovascular disease, adjunctive therapy with niacin is superior to therapy with ezetimibe, according to a study published online Nov. 15 in The New England Journal of Medicine to coincide with the American Heart Association Scientific Sessions, held from Nov. 14 to 18 in Orlando, Fla.
Allen J. Taylor, M.D., of the Walter Reed Army Medical Center in Washington, D.C., and colleagues randomly assigned patients who had coronary heart disease or a coronary heart disease risk equivalent and were receiving statin therapy to receive either extended-release niacin or ezetimibe for 14 months. The subjects had a "therapeutic" low-density lipoprotein (LDL) cholesterol level below 100 mg/dL and a high-density lipoprotein (HDL) level of under 50 mg/dL for men or 55 mg/dL for women Two hundred eight patients completed the trial. The trial was stopped early due to efficacy.
The researchers found that niacin increased HDL levels by 18.4 percent, and also reduced levels of LDL cholesterol and triglycerides. Although ezetimibe was associated with a mean reduction in LDL of 19.2 percent, patients taking it had increased carotid intima-media thickness, while patients taking niacin had decreased thickness. Rates of major cardiovascular events were also significantly lower in the niacin group (1 versus 5 percent).
"Unfortunately, the premature termination of the ARBITER 6-HALTS trial, the small number of patients studied, and the limited duration of follow-up preclude us from conclusively declaring niacin the adjunctive agent of choice on the basis of the evidence," states the author of an accompanying editorial.
The study was supported by Abbott; several authors reported financial relationships with Abbott or other pharmaceutical companies.