BACKGROUND
Previous trials have shown that the use of statins to lower cholesterol reduces the risk
of cardiovascular events among persons without cardiovascular disease. Those trials
have involved persons with elevated lipid levels or inflammatory markers and involved
mainly white persons. It is unclear whether the benefits of statins can be extended to
an intermediate-risk, ethnically diverse population without cardiovascular disease.
METHODS
In one comparison from a 2-by-2 factorial trial, we randomly assigned 12,705 participants
in 21 countries who did not have cardiovascular disease and were at intermediate
risk to receive rosuvastatin at a dose of 10 mg per day or placebo. The first
coprimary outcome was the composite of death from cardiovascular causes, nonfatal
myocardial infarction, or nonfatal stroke, and the second coprimary outcome additionally
included revascularization, heart failure, and resuscitated cardiac arrest. The
median follow-up was 5.6 years.
RESULTS
The overall mean low-density lipoprotein cholesterol level was 26.5% lower in the
rosuvastatin group than in the placebo group. The first coprimary outcome occurred
in 235 participants (3.7%) in the rosuvastatin group and in 304 participants (4.8%)
in the placebo group (hazard ratio, 0.76; 95% confidence interval [CI], 0.64 to 0.91;
P = 0.002). The results for the second coprimary outcome were consistent with the
results for the first (occurring in 277 participants [4.4%] in the rosuvastatin group
and in 363 participants [5.7%] in the placebo group; hazard ratio, 0.75; 95% CI, 0.64
to 0.88; P<0.001). The results were also consistent in subgroups defined according
to cardiovascular risk at baseline, lipid level, C-reactive protein level, blood pressure,
and race or ethnic group. In the rosuvastatin group, there was no excess of diabetes
or cancers, but there was an excess of cataract surgery (in 3.8% of the participants,
vs. 3.1% in the placebo group; P = 0.02) and muscle symptoms (in 5.8% of
the participants, vs. 4.7% in the placebo group; P = 0.005).
CONCLUSIONS
Treatment with rosuvastatin at a dose of 10 mg per day resulted in a significantly
lower risk of cardiovascular events than placebo in an intermediate-risk, ethnically
diverse population without cardiovascular disease. (Funded by the Canadian
Institutes of Health Research and AstraZeneca; HOPE-3 ClinicalTrials.gov number,
NCT00468923.)