Intensive statin therapy with atorvastatin 80 mg reduced the composite of death, MI, unstable angina, revascularization, or stroke in women (HR 0.75; 95% CI 0.57-0.99; P=0.04).
RCT (n=4,162)
Does intensive statin therapy (atorvastatin 80 mg) reduce cardiovascular events compared to standard therapy (pravastatin 40 mg) in women and men after acute coronary syndrome?
Intensive statin therapy significantly reduces cardiovascular events in both women and men following acute coronary syndrome, demonstrating that sex should not limit the use of intensive statin therapy.
Hazard Ratio: 0.75 (95% CI 0.57–0.99)
p-value: p=0.04
BACKGROUND: Despite the known benefit of intensive statin therapy for reducing future cardiovascular events, its effectiveness in women has been questioned by some. METHODS AND RESULTS: In the Pravastatin or Atorvastatin Evaluation and Infection Therapy-Thrombolysis in Myocardial Infarction 22 (PROVE IT-TIMI 22) trial, 911 (21.9%) women and 3251 (78.1%) men were randomized to intensive statin (atorvastatin 80 mg) versus standard therapy (pravastatin 40 mg) therapy for a median duration of 2.1 years. The primary end point was death, myocardial infarction, unstable angina; revascularization (occurring after 30 days); or stroke. Safety end points included elevations in liver function tests, creatine kinase, and myalgias/myositis. Women had a reduction in low-density lipoprotein (LDL) of 42.8% from baseline at 30 days (to a median of 60 mg/dL) in the intensive therapy arm, with 88.8% reaching the LDL goal of <100 mg/dL and 65.0% of <70 mg/dL, compared with a 16.8% reduction in LDL (to a median of 88 mg/dL) in the standard therapy arm. Women receiving intensive statin therapy had a significant 25% relative reduction over standard dose (hazard ratio, 0.75; 95% CI, 0.57 to 0.99; P=0.04) for the primary composite end point compared with a 14% reduction for men (hazard ratio, 0.86; 95% CI, 0.75 to 0.99; P=0.04; P-interaction, 0.38). No differences were observed between sexes for safety (all P-interaction ≥0.11). CONCLUSIONS: This trial provides evidence that both women and men derived benefit from intensive statin therapy after acute coronary syndrome, and thus, sex should not be a factor in determining who should be treated with intensive statin therapy.
Truong et al. (Wed,) conducted a rct in Acute coronary syndrome (n=4,162). Intensive statin therapy (atorvastatin) vs. Standard therapy (pravastatin 40 mg) was evaluated on death, myocardial infarction, unstable angina; revascularization (occurring after 30 days); or stroke (HR 0.75, 95% CI 0.57 to 0.99, p=0.04). Intensive statin therapy with atorvastatin 80 mg reduced the composite of death, MI, unstable angina, revascularization, or stroke in women (HR 0.75; 95% CI 0.57-0.99; P=0.04).