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Statin plus Niacin Benefits CAD Patients with Low HDL

How well does combination lipid-modifying therapy benefit patients with coronary artery disease (CAD) and low HDL-cholesterol levels? In this 3-year, double-blind trial, researchers randomized 160 such patients (HDL, 35 mg/dL in men and 40 mg/dL in women) to 1 of 4 regimens: simvastatin and niacin; antioxidants (vitamin E, vitamin C, beta-carotene, and selenium); simvastatin and niacin plus antioxidants; or matching placebos. The primary endpoints were 3-year angiographic evidence of change in percent stenosis and 38-month incidence of cardiac-related death, nonfatal MI, stroke, or revascularization for worsening ischemia.

In the antioxidants-alone group, no lipid-modifying benefit was found. In the simvastatin-niacin group, mean LDL level dropped by 42% and mean HDL level increased by 26% from baseline to 3-year follow-up. Adding antioxidants to the simvastatin-niacin regimen actually diminished its HDL-raising effect.

The mean percent stenosis in proximal arteries increased by 3.9% in placebo recipients, by 1.8% in antioxidants-alone recipients, and by 0.7% in recipients of simvastatin-niacin plus antioxidants; in the simvastatin-niacin (without antioxidants) group, a decrease of 0.4% was found. Incidence of the combined clinical endpoint (defined above) was about 90% lower in the simvastatin-niacin group than in the placebo group (3% vs. 24%, P=0.03); the differences between other treatments and placebo were nonsignificant.

Comment: This study documents clinical and angiographic benefits of combination lipid-altering therapy in CAD patients with low HDL -- benefits greater than what would be expected from statins alone. An editorialist emphasizes that antioxidants attenuated the benefits of statin-niacin treatment. These findings represent a substantial advance in knowledge with direct clinical relevance for the many CAD patients with low HDL-cholesterol levels.

— JoAnne M. Foody, MD

Published in Journal Watch Cardiology January 18, 2002

Citation(s):

Brown BG et al. Simvastatin and niacin, antioxidant vitamins, or the combination for the prevention of coronary disease. N Engl J Med 2001 Nov 29; 345:1583-92.

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Freedman JE. Antioxidant versus lipid-altering therapy -- Some answers, more questions. N Engl J Med 2001 Nov 29; 345:1636-7.

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• Medline abstract (Free)