Physicians' Academy for Cardiovascular Education

Statins equally effective in men and women?

Literature - Gutierrez J et al, Arch Intern Med. 25 june 2012;172:909-919

Statin therapy in the prevention of recurrent cardiovascular events - A sex-based meta-analysis

Gutierrez J, Ramirez G, Rundek T, Sacco RL.
Arch Intern Med. 2012;172:909-919


Background

Most statin trials predominantly enrolled men. There have been conflicting results on the benefits obtained in women compared with men in secondary cardiovascular disease prevention. In this study, a sex-based meta-analysis was performed, seeking to determine if statins yield a similar protective effect on both men and women in preventing recurrent cardiovascular events.
11 secondary prevention, double-blinded, placebo-controlled trials were analysed, which included 43, 193 patients (11,229 women and 31,962 men).

Main results

  • Overall, statin therapy was associated with a significant reduction in overall CV outcomes for both men and women. 
  • For all-cause mortality and stroke, the benefit in women did not achieve statistical significance
     
All CV outcomes:
  • women: RR 0.81, CI 0.74-0.89
  • men: RR 0.82, CI 0.78- 0.85
All-cause mortality:
  • women: RR 0.92, CI 0.76-1.13
  • men: RR 0.79, CI 0.72-.87
Stroke:
  • women: RR 0.92, CI 0.76-1.10
  • men: RR 0.81, CI 0.72-0.92

Figure 1.

 Any cardiovascular event (cardiac and/or cerebrovascular)

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Conclusion

Both sexes gain from statins for secondary prevention of cardiovascular events, though pooling enough data to prove that there is a statistically significant benefit in women appears to be a challenge.


Invited commentary [1]

“It is misleading to focus on the lack of statistical significance in women. The real issue is not significance but whether the effect size in women is materially different from the effect size in men. The effect on stroke and all-cause mortality in women is consistent with the effect in men. Statins work just as well in women as in men.”


Editorial comment [2]

“We should not assume women are the same as men. Unless we increase inclusion of women in clinical trials and report sex-specific data, there will never be sufficient data to achieve optimal care of all of our patients.”


References

1. Taylor F, Ebrahim S. Statins work just as well in women as in men. Arch Intern Med. 2012;172:919-920
2. Redberg RF. Don’t assume women are the same as men: include them in the trial. Arch Intern Med. 2012;172:921


Abstract

Background:
The effect of statins on the prevention of cardiovascular events is well demonstrated. Whether this protective effect is equal for women and men remains less well established. Our objective was to evaluate if statin therapy is equally effective in decreasing recurrent cardiovascular events in women and men.

Data Sources:
 Randomized clinical trials were searched in PubMed using as indexing terms (statins OR cholesterol lowering medications)AND(cardiovascular events OR stroke OR myocardial infarction OR cardiovascular death). Study Selection: We included randomized, doubleblinded, placebo-controlled trials evaluating statins for secondary prevention of cardiovascular events. Studies with an open-label design and observational studies were excluded.

Data Extraction:
 The earliest citation was used to determine the characteristic of the studied population and the methodology. All subsequent citations corresponding to the trial were evaluated for outcome rates by sex.

Data Synthesis:
Eleven trials representing 43 193 patients were included in the analysis. Overall, statin therapy was associated with a reduced risk of cardiovascular events in all outcomes for women (relative risk [RR], 0.81 [95% CI, 0.74-0.89]) and men (RR, 0.82 [95% CI, 0.78- 0.85]). However, they did not reduce all-cause mortality in women vs men (RR, 0.92 [95% CI, 0.76-1.13] vs RR, 0.79 [95% CI, 0.720.87]) or stroke (RR, 0.92 [95% CI, 0.76-1.10] vs RR, 0.81 [95% CI, 0.72-0.92]).

Conclusions:
 Statin therapy is an effective intervention in the secondary prevention of cardiovascular events in both sexes, but there is no benefit on stroke and allcause mortality in women.

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