Although clinical trials have consistently found a beneficial effects for statins, some critics have questioned the strength of the evidence in women, who are often under-represented in clinical trials. A large new meta-analysis published in the Journal of the American College of Cardiology provides the best evidence yet that the relative reductions in events observed in men also occur in women, but doesn’t provide evidence about the absolute risk benefit in women.
William Kostis and colleagues analyzed data from 18 randomized trials of primary and secondary prevention, including 141,235 men and 40,275 women. The reduction in risk was similar for both groups:
- women: OR: 0.81, CI 0.75 – 0.89, p < 0.0001
- men: OR: 0.77, CI: 0.71 – 0.83, p < 0.0001
- women: OR: 0.90, CI: 0.82 – 0.99, p = 0.0344
- men: OR: 0.84, CI: 0.77 – 0.92, p = 0.0003
For women the effect on all-cause mortality did not achieve statistical significance in the secondary prevention trials, while for men the difference in mortality did not achieve significance in the primary prevention trials. However, investigators did not find a significant interaction by sex in these analyses.
The authors concluded that “statin therapy should be used in appropriate patients without regard to sex. It seems that, with respect to statin therapy, what is good for the gander is good for the goose.”
In an accompanying editorial comment, Lori Mosca praises the meta-analysis, but notes that it only treats “sex-specific relative risk benefit and not absolute benefit,” and that both are needed “to make informed clinical choices with regard to the use of statins for primary prevention.” She also noted that the meta-analysis did not provide any evidence about the relative safety of statins in women.