The American Heart Association acknowledges that cardiovascular medications are beneficial to patients in randomized clinical trials; however, ethnic minorities, women, and elderly are continually underrepresented in many trials.1 Since most participants in these studies are males, it is not clear if the efficacy of statins for secondary prevention is equivalent for men and women.
Gutierrez and colleagues conducted a meta-analysis of trials that evaluated the use of any statin at any dose for secondary prevention of cardiovascular events in both men and women.2 The 11 trials that were included had 43,191 total patients, of which only about 20% were women. Nearly one fourth of all the patients in this meta-analysis were from the ASCOT-LLA study, where secondary prevention was defined as greater than 3 cardiovascular disease risk factors. Other studies defined secondary prevention as a prior myocardial infarction, angina (stable or unstable), any cardiac intervention, any stroke, or transient ischemic attack.
Analyses revealed statins decrease the risk for cardiovascular events (i.e., myocardial infarction, coronary death, and/or stroke) in women (RR 0.81; [95% CI 0.74-0.89]). However, statins did not reduce all-cause mortality in women (RR 0.92 [95% CI, 0.76-1.13]) or stroke (RR, 0.92 [95% CI, 0.76-1.10]). The authors concluded that statin therapy is an effective intervention in the secondary prevention of cardiovascular events in both sexes; however, there is no benefit on stroke and all-cause mortality in women.
This meta-analysis sheds some light on the debate of the true efficacy of statins in women. While the risk of any cardiovascular event was decreased with statin therapy, this study questioned whether statin therapy will decrease all-cause mortality or any stroke for women. Conclusions must be scrutinized as less than one fifth of total patients were women; the definition of secondary prevention allowed a wide variety of patients; 14 trials were excluded as they did not publish event rates for both genders; variable follow-up time of included studies (16 months to 6 years), and the large variety of statins and dosage regimens.
Though data in women remain controversial, this study establishes the benefit of statins for preventing cardiovascular events in women, and statins should remain a mainstay of secondary prevention therapy for women. However, there is still an astonishing lack of women enrolled in secondary prevention studies. Thus, we should continue to urge the underrepresented patient participation in clinical trials to gain additional evidence to appropriately guide secondary prevention therapy.
1. Smith SC Jr, Benjamin EJ, Bonow RO, et al. AHA/ACCF Secondary Prevention and Risk Reduction Therapy for Patients With Coronary and Other Atherosclerotic Vascular Disease: 2011 Update A Guideline From the American Heart Association and American College of Cardiology Foundation Endorsed by the World Heart Federation and the Preventive Cardiovascular Nurses Association. J Am Coll Cardiol
2. Gutierrez J, Ramirez G, Rundek T, et al. Statin Therapy in the Prevention of Recurrent Cardiovascular Events: A Sex-Based Meta-analysis. Arch Intern ...