June 25th, 2012

Are Statins Equally Effective in Women and in Men?

Jose Gutierrez and colleagues performed a sex-based meta-analysis, seeking to determine if statins yield a similar protective effect on both men and women in preventing recurrent cardiovascular events. In a paper published in the Archives of Internal Medicine, they report the results of their meta-analysis of 11 secondary prevention, double-blinded, placebo-controlled trials, which included 43, 193 patients (11,229 women and 31,962 men).

Overall, statin therapy was associated with a significant reduction in overall CV outcomes for both men and women. For all-cause mortality and stroke, however, 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


  • women: RR 0.92, CI 0.76-1.10
  • men: RR 0.81, CI 0.72-0.92

The smaller sample size of women is one possible explanation for the lack of a significant difference in mortality and stroke, according to the authors. Other factors — including the worse cardiovascular profile of women and lower use of antiplatelet agents in women — might also play a role, they speculate.

In an invited commentary, Fiona Taylor and Shah Ebrahim write that 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,” they write, and note that “the effect on stroke and all-cause mortality in women is consistent with the effect in men.” They conclude that “statins work just as well in women as in men.”

In an editor’s note, Rita Redberg states that we should not “assume women are the same as men.” She writes that “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.”

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