Background: Evidence of lipid-lowering from clinical trials that included women is adequate to support their use in secondary prevention in women with known coronary disease. However the role of statin therapy in primary prevention is still controversial, in particular for female gender. The aim of our study is to perform a meta-analysis comparing by gender the cardiovascular outcomes related to statin therapy in primary prevention.
Methods: We performed a meta-analysis including 8 randomized controlled trials (19,052 and 30,194 men, mean follow-up 3.9 years) that assessed the cardiovascular outcomes related to statin therapy, including studies that provided sex-specific results. MEDLINE and the Cochrane Database, were searched for articles published in English and other languages up to March 2008.
Results: Statins do not appear to have a beneficial effect on total mortality for both men and women in primary prevention over the 2.8- to 5.3 year study period (men: 95% Confidence Interval (CI) 0.83-1.04; comparison p = 0.22; women: 0.96; CI 0.81-1.13; p = 0.61). Statin therapy reduced the risk of coronary heart disease (CHD) events in men (0.59; CI 0.48-0.74; p = 0.0001), however in women this risk reduction was weakly significant (0.89 CI 0.79-1.00; p = 0.05) and disappeared when in sensitivity analysis, trials not entirely of primary prevention were excluded (HPS, PROSPER) (0.95 CI 0.78-1.16; comparison p = 0.562).
Conclusions: Our study showed that statin therapy reduced the risk of CHD events in men without prior cardiovascular disease, but not in women. Statins did not reduce the risk of total mortality both in men and women.