Abstract and Introduction

Abstract

Objectives The aim of this study was to evaluate the effect of statins in decreasing cardiovascular events in women and men.
Background Published data reviews have suggested that statins might not be as effective in women as in men in decreasing cardiovascular events.
Methods Published data searches and contacts with investigators identified 18 randomized clinical trials of statins with sex-specific outcomes (N = 141,235, 40,275 women, 21,468 cardiovascular events). Odds ratios (ORs) and 95% confidence intervals (CIs) for cardiovascular events were calculated for women and men separately with random effects meta-analyses.
Results The cardiovascular event rate was lower among those randomized to statin intervention than in those randomized to control (low-dose statin in 4 studies, placebo in 11 studies, usual care in 3 studies) and similar in women and men (OR: 0.81, 95% CI: 0.75 to 0.89; p < 0.0001, and OR: 0.77, 95% CI: 0.71 to 0.83, p < 0.0001, respectively). 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).
Conclusions 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.

Introduction

Randomized controlled clinical trials and meta-analyses have shown a benefit of statins in decreasing morbid and mortal cardiovascular events in apparently healthy individuals and in those with clinically evident cardiovascular disease (CVD).^[1–6] However, there is insufficient information on the benefits of statins in women especially in primary prevention.^[7–9] Reviews and meta-analyses have shown improved outcomes with statins in both women and men without significant interaction by sex.^[10–11] 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.^[12–15]

The purpose of this report is to present a meta-analysis of sex-specific outcomes in controlled randomized clinical trials of statin therapy.

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