Simvastatin and Niacin, Antioxidant Vitamins, or the Combination for the Prevention of Coronary Disease

TLDR

Lipid‑modifying therapy and antioxidant vitamins are thought to benefit patients with coronary disease. The study evaluated simvastatin‑niacin, antioxidant vitamins, and their combination for cardiovascular protection in coronary disease patients with low HDL over a three‑year double‑blind trial of 160 participants. Endpoints were angiographic changes in coronary stenosis and first cardiovascular events, while LDL and HDL levels were measured, showing a 42 % LDL reduction and a 26 % HDL increase with simvastatin‑niacin. Simvastatin‑niacin markedly reduced LDL, increased HDL, slowed stenosis progression, and lowered cardiovascular events from 24 % to 3 %, whereas antioxidant vitamins alone or combined with simvastatin‑niacin offered little benefit and even attenuated HDL2 gains, suggesting their use should be questioned.

Abstract

Both lipid-modifying therapy and antioxidant vitamins are thought to have benefit in patients with coronary disease. We studied simvastatin-niacin and antioxidant-vitamin therapy, alone and together, for cardiovascular protection in patients with coronary disease and low plasma levels of HDL.In a three-year, double-blind trial, 160 patients with coronary disease, low HDL cholesterol levels and normal LDL cholesterol levels were randomly assigned to receive one of four regimens: simvastatin plus niacin, vitamins, simvastatin-niacin plus antioxidants; or placebos. The end points were arteriographic evidence of a change in coronary stenosis and the occurrence of a first cardiovascular event (death, myocardial infarction, stroke, or revascularization).The mean levels of LDL and HDL cholesterol were unaltered in the antioxidant group and the placebo group; these levels changed substantially (by -42 percent and +26 percent, respectively) in the simvastatin-niacin group. The protective increase in HDL2 with simvastatin plus niacin was attenuated by concurrent therapy with antioxidants. The average stenosis progressed by 3.9 percent with placebos, 1.8 percent with antioxidants (P=0.16 for the comparison with the placebo group), and 0.7 percent with simvastatin-niacin plus antioxidants (P=0.004) and regressed by 0.4 percent with simvastatin-niacin alone (P<0.001). The frequency of the clinical end point was 24 percent with placebos; 3 percent with simvastatin-niacin alone; 21 percent in the antioxidant-therapy group; and 14 percent in the simvastatin-niacin-plus-antioxidants group.Simvastatin plus niacin provides marked clinical and angiographically measurable benefits in patients with coronary disease and low HDL levels. The use of antioxidant vitamins in this setting must be questioned.