Background: Prior primary prevention trials of statin therapy that used cholesterol criteria for enrollment have not reported significant decreases in stroke risk. We evaluated whether statin therapy might reduce stroke rates among individuals with low levels of cholesterol but elevated levels of high-sensitivity C-reactive protein.
Methods and results: In Justification for the Use of statins in Prevention: an Intervention Trial Evaluating Rosuvastatin (JUPITER), 17 802 apparently healthy men and women with low-density lipoprotein cholesterol levels <130 mg/dL and high-sensitivity C-reactive protein levels > or = 2.0 mg/L were randomly allocated to rosuvastatin 20 mg daily or placebo and then followed up for the occurrence of a first stroke. After a median follow-up of 1.9 years (maximum, 5.0 years), rosuvastatin resulted in a 48% reduction in the hazard of fatal and nonfatal stroke as compared with placebo (incidence rate, 0.18 and 0.34 per 100 person-years of observation, respectively; hazard ratio 0.52; 95% confidence interval, 0.34 to 0.79; P=0.002), a finding that was consistent across all examined subgroups. This finding was due to a 51% reduction in the rate of ischemic stroke (hazard ratio, 0.49; 95% confidence interval, 0.30 to 0.81; P=0.004), with no difference in the rates of hemorrhagic stroke between the active and placebo arms (hazard ratio, 0.67; 95% confidence interval, 0.24 to 1.88; P=0.44).
Conclusions: Rosuvastatin reduces by more than half the incidence of ischemic stroke among men and women with low levels of low-density lipoprotein cholesterol levels who are at risk because of elevated levels of high-sensitivity C-reactive protein.
Clinical trial registration: clinicaltrial.gov. Unique identifier: NCT00239681.