Establishing the benefit of statins in low-to-moderate--risk primary prevention: the Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS).

Overview

AFCAPS/TexCAPS was the first prevention trial of a statin conducted in a low-to-moderate-risk cohort that included men (> or =45 years) and women (> or =55 years) with no evidence of atherosclerotic cardiovascular disease. At study entry, LDL-C had to be 130-190 mg/dL and HDL-C < or =45 mg/dL for men and < or =47 mg/dL for women. Participants were randomized to either lovastatin 20-40 mg/day (n=3304) or placebo (n=3301) for a mean follow-up period of 5.2 years. At 1 year, in the lovastatin group TC, LDL-C, and TG were reduced by 18.4%, 25.0%, and 15%, respectively. HDL-C increased by 6.0%. At 5 years, there was a 37% decrease in the relative risk for having a first acute coronary event in the lovastatin versus placebo group. Women showed similar relative risk reduction as men. Older individuals benefited as much as younger ones from lovastatin. Subjects with > or =2 risk factors benefited more from statin than those with <2 risk factors. At baseline, HDL-C but not TC or LDL-C was determined a significant predictor of risk. On treatment, ApoB and ApoA1 were the best predictors. Based on AFCAPS/TexCAPS, a simple heuristic could be that individuals with "age plus one other risk factor" may benefit from statin therapy in primary prevention.