June 25, 2012 (New York, New York) — The debate as to whether statins have less benefit in women than in men rumbles on. The latest contribution to this saga is a new meta-analysis suggesting that statins are effective in the secondary prevention of cardiovascular events in both men and women, but there is no significant benefit on stroke and all-cause mortality in women [1].
The analysis, published in the June 25, 2012 issue of the Archives of Internal Medicine, was conducted by a group led by Dr Jose Gutierrez (Columbia University, New York).
They say that while the results support the use of statins in women for the secondary prevention of cardiovascular events, they also underscore differences in the benefit obtained from statins in women compared with men. “These differences are likely secondary to the small proportion of women included in the trials and a worse cardiovascular health status in these same women,” they conclude.
Critical Commentary
But authors of an accompanying commentary suggest that statins work just as well in women as in men [2]. Drs Fiona Taylor and Shah Ebrahim (Cochrane Heart Group, London School of Hygiene and Tropical Medicine, London, UK) note that Gutierrez and colleagues may have omitted some relevant studies from their meta-analysis, adding that a recent meta-analysis using more inclusive criteria showed similar benefits in women and men for stroke outcomes.
They further point out that by adding the Heart Protection Study to the current analysis, this would result in a risk ratio of 0.89 for all-cause mortality in women, with an upper confidence limit of 1.01.
They argue that focusing on a lack of statistical significance in the findings for women is misleading and that the real issue is not significance but whether the effect size in women is materially different from the effect size in men, which it is not for either stroke or all-cause mortality.
Statins are clearly beneficial in women.
Responding to these arguments to heartwire , Gutierrez commented: “The lack of significance for the stroke and mortality outcomes in our analysis may well be because of lack of power. I am not obsessed with statistical significance–statins are clearly beneficial in women, and I do advocate that women take statins. But we did observe higher rates of hypertension and diabetes and a lower use of aspirin in women than in men, and this may also have contributed to the results. In our study, general cardiovascular care did not appear to be as good in women as it was men, and that needs to be addressed.”
Include More Women in Trials
Dr Rita Redberg summarizes the situation with a question in an editor’s note [3]: “Are the benefits of statins less in women and risks greater than men, or are there just not enough women in the clinical trials to demonstrate benefit?” She concludes, “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.”
For the current meta-analysis, Gutierrez et al included 11 placebo-controlled trials evaluating statins for secondary prevention with a total of 43 193 patients, 20% of whom were women.
Overall, statin therapy was associated with a reduced risk of cardiovascular events for women and men. In terms of all-cause mortality and stroke, a significant benefit was seen with statins in men but not in women.
Risk Ratio (95% CI) for Major Outcomes With Statins
| Outcome | Men | Women |
| Cardiovascular events | 0.82 (0.78–0.85) | 0.81 (0.74–0.89) |
| All-cause mortality | 0.79 (0.72–0.87) | 0.92 (0.76–1.13) |
| Stroke | 0.81 (0.72–0.92) | 0.92 (0.76–1.10) |
— Sue Hughes
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