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Randomized controlled clinical trials and meta-analyses have shown a benefit of statins in decreasing morbid and mortal cardiovascular events in apparently healthy individ- uals and in those with clinically evident cardiovascular disease. However, there is insufficient infor- mation on the benefits of statins in women especially in primary prevention. Reviews and meta-analyses have shown improved outcomes with statins in both women and men without significant interaction by sex. However, they did not show statistically significant effects in women. This could be related to under-representation of women in trials and underscores the need to explore sex-related differences that would provide a basis for clinical strategies to improve outcomes for women.
The purpose of this report is to present a meta-analysis of sex-specific outcomes in controlled randomized clinical trials of statin therapy. The findings of this study are consonant with a wealth of information from randomized clinical trials and meta- analyses. In the present study, the benefit of statins in reducing primary endpoints was observed in women and men and in both primary and secondary prevention without significant difference between the 2 sexes. Lower all-cause mortality was also observed in both women and men. Meta-regression with stepwise variable selection suggested that the benefit was more pronounced in men in studies with higher percentages of smokers or patients with CVD and lower percentage on aspirin. The mortality benefit was statistically significant for primary prevention in women and for secondary prevention in men, although there was no significant interaction by sex in these analyses.
The benefit of statins was statistically significant in both sexes, regardless of the type of control, baseline risk, or type of endpoint and in both primary and secondary prevention. All-cause mortality was also lower with statin therapy both in women and men without significant interaction by sex (p for interaction 0.4457).
The study conclusion is that statin therapy is associated with significant decreases in cardiovascular events and in all-cause mortality in women and men. Statin therapy should be used in appropriate patients without regard to sex.