Abstract

There are more women than men living with cardiovascular disease, and the absolute annual number of cardiovascular deaths among women exceeds that in men.1 Although sex differences in cardiovascular risk are recognized in the risk stratification tools (eg, Framingham Risk Score, CHA2DS2-VASc score) and sex-specific risk management guidelines developed for clinical practice, it has to be recognized that women remain underrepresented in clinical trials. Approximately half of the individuals with hypertension, diabetes mellitus, or coronary artery disease are women, yet women make up only 25% to 44% of patients enrolled in trials studying these disorders.2 Furthermore, fewer than a third of primary trial publications include sex-specific results.2 Article see p 934 The sex-specific analysis of the large Ongoing Telmisartan Alone and in Combination With Ramipril Global End Point Trial (ONTARGET) and Telmisartan Randomized Assessment Study in ACE-Intolerant Subjects With Cardiovascular Disease (TRANSCEND) trials by Kappert et al3 adds new data from 9378 women and 22 168 men with or at high risk of cardiovascular disease. Despite the large number of women, they made up <30% of the study population. The analysis was performed to assess sex differences in outcomes regardless of treatment arm. Such an analysis, derived from large randomized, controlled trials, provides the advantage of systematic follow-up and adjudication of outcomes in a controlled setting but the potential disadvantage of selection bias. The baseline characteristics of the study population demonstrate important differences: Women were more likely to qualify for entry into the trials with diabetes mellitus and stroke, whereas men were more likely to have coronary artery disease. Women were also older and more likely to be hypertensive and obese than men. Lifestyle factors differed, with women being less active and less likely to consume tobacco or alcohol and having received less education than men. …

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