Impact of Gender on Cardiovascular Outcome in Patients at Cardiovascular High Risk: Analysis of the Telmisartan Randomized AssessmeNT Study in ACE-INtolerant Subjects with Cardiovascular Disease (TRANSCEND) and the Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET)
Background—Epidemiological data suggests that gender independently contributes to cardiovascular risk. Clinical trials are often hampered by few female patients enrolled.
Methods and Results—The Ongoing Telmisartan Alone and in Combination with Ramipril Global Endpoint Trial (ONTARGET) and the parallel Telmisartan Randomised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease (TRANSCEND) included a large proportion of female patients (9,378 females vs. 22,168 males). Differences in male vs. female patients enrolled in ONTARGET/TRANSCEND were analyzed for the primary 4-fold endpoint (composite of cardiovascular (CV) death, myocardial infarction (MI), stroke, or admission to hospital for heart failure (CHF)), a secondary 3-fold endpoint (CV death, MI, stroke) and individual components of the primary composite. Baseline characteristics included age, ethnicity, BMI, physical activity, tobacco use, alcohol consumption, formal education, clinical diagnosis for study entry, patient history, and concomitant medication. Patients were followed until death or the end of the study (median: 56 months). Compared with males females had a 19% significantly lower risk for the 4-fold endpoint and 21% for the 3-fold endpoint (after adjustment for study, treatment, and the above baseline values). Similarly, the adjusted risk for CV death (17%), and for MI (22%), but not for stroke and hospitalization for CHF, was also significantly lower in females. Diabetic females were characterized by a higher risk for acute MI compared to diabetic males, while alcohol consumption resulted in significantly lower risk in females.
Conclusions—In our analysis with 70.3% males and 29.7% females, a ~20% lower risk for the combined cardiovascular endpoints in female patients was observed, despite treatment with cardioprotective agents; this was primarily driven by a significantly lower incidence of MI. Thus, we demonstrate in a large interventional trial that gender greatly impacts on the occurrence of cardiovascular events in patients with vascular disease or high risk diabetes.
Clinical Trial Registration Information—www.clinicaltrials.gov; Identifier: NCT00153101.
- Received December 29, 2011.
- Accepted May 30, 2012.
- Copyright © 2012, American Heart Association, Inc. All rights reserved. Unauthorized use prohibited