Smaller benefit of statins without heart disease

Clinical Question

Is there a benefit of statin therapy to lower cholesterol in patients without cardiovascular disease?

Bottom Line

In patients without pre-existing heart disease, statin treatment of elevated low-density lipoprotein (LDL) cholesterol will decrease their risk of a first major coronary event and, to a lesser extent, a first cerebrovascular event. Overall mortality and mortality related to heart disease will not be affected by treatment. (LOE = 1a)


Thavendiranathan P, Bagai A, Brookhart MA, Choudhry NK. Primary prevention of cardiovascular diseases with statin therapy. Arch Intern Med 2006;166:2307-2313.  [PMID:17130382]

Study Design

Meta-analysis (randomized controlled trials)


Unknown/not stated


Various (meta-analysis)


In patients without cardiovascular disease, the effect of cholesterol lowering on outcomes that matter is much less than in patients with cardiovascular disease. This meta-analysis combined the results of 7 studies enrolling almost 43,000 patients. To find these studies, the authors searched 4 databases, focusing only on randomized studies of statins compared with a control drug in patients without known heart disease. The studies had to be of at least 1 year in duration and report at least 100 cardiovascular outcomes during the study. Two investigators independently extracted the data. Patients in the studies were between the ages of 55 years and 74 years; the majority were male. The mean LDL cholesterol level was 147 mg/dL (3.82 mmol/L) and was decreased an average of 26% during the study. The likelihood of a major coronary event was significantly decreased with statin therapy over an average 4.3 years of treatment. (number needed to treat = 73; 95% CI, 56-104). Major cerebrovascular events were also decreased, with 1 fewer event for every 281 patients treated (157 - 1309). Overall mortality and heart disease-related mortality were not affected by treatment. This is not likely to be a result of small numbers of deaths, since an average 6.6% of people in the control group died, which is similar to the incidence of major coronary events.