11 Jul, 16 | by flee
Implementation of statin therapy in practice for primary prevention of cardiovascular disease is controversial due to concerns over costs and side-effects with broader use and uncertainty regarding LDL goals in the primary prevention population. Previous primary prevention trials suggest a reduction in cardiovascular outcomes in largely white patients with significant risk factors for coronary disease. The HOPE-3 trial randomized a diverse population of 12,000 individuals over 55 years of age (women over 60) with 1-2 relatively modest risk factors for cardiovascular disease (annual risk ~1%) but otherwise no indication for statin therapy to 10 mg of rosuvastatin daily vs placebo. The composite primary outcome was death from cardiovascular causes, non- fatal MI or stroke. Nearly 13% of patients were excluded following roll-in based on side-effects or lab abnormalities. For remaining patients, over median follow of 5.6 years there was a significant reduction in the primary endpoint: 3.7% vs 4.8% favoring treatment (HR 0.76 [CI 0.64-0.91]) with a NNT of 91. An expanded ‘co-primary’ outcome which also included heart failure, revascularization and resuscitated cardiac arrest resulted in a NNT of 73. Of note, there was a significant increase in muscle aches and weakness in the rosuvastatin group (5.8% vs 4.7%) but this did not clearly impact drug discontinuation, which was common at 23.7%. In fact, therapy discontinuation was 2.5% higher in the placebo group. Myopathy or rhabdomyolysis events were very rare, but there was a significant increase in cataracts in the rosuvastin group.