Abstract 1426: Rosuvastatin for the Primary Prevention of Cardiovascular Events in Women With Elevated hsCRP and Low LDLC: Sex-Specific Outcomes From the JUPITER Trial
Background Statin therapy in women without manifest cardiovascular disease is controversial given insufficient prior evidence for benefit. We conducted a sex-specific analysis of outcomes in the JUPITER trial, a randomized trial of rosuvastatin 20 mg daily among 17,802 apparently healthy men and women with LDLC <130 mg/dL and hsCRP ≥2 mg/L.
Methods 6,801 women ≥60 years and 11,001 men ≥50 years were randomized to rosuvastatin or placebo and followed for the trial primary endpoint (first event of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or cardiovascular death), and for adverse events. Median follow-up was 1.9 years (maximum 5 years).
Results At baseline, women were older, had more prevalent hypertension and metabolic syndrome, and less smoking. While the absolute rates (per 100 person-years) of the primary endpoint in rosuvastatin and placebo were lower in women (0.57 and 1.04, respectively) than men (0.88 and 1.54, respectively), the relative risk reduction with rosuvastatin was similar and statistically significant in both women (hazard ratio 0.54, 95% CI 0.37– 0.80, P=0.002) and men (0.58, 95% CI 0.45– 0.73, P<0.001). Consistent with data for men, risk reductions among women were observed for all components of the primary endpoint. The largest benefit for women was for arterial revascularization (hazard ratio 0.24, 95%CI 0.11– 0.51, P <0.001). Rosuvastatin was not associated with a significant increase in myopathy or cancer in either sex. A higher incidence of physician-reported diabetes occurred in women on rosuvastatin vs placebo (1.59 vs 1.05%, respectively, P=0.008) but not in men (1.48 vs 1.32%, respectively, P=0.29).
Conclusions Among apparently healthy women with elevated hsCRP but low LDLC, rosuvastatin resulted in similar and significant proportional reductions in cardiovascular events compared with men. The higher incidence of diabetes with rosuvastatin occurred only in women.