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)

Study Questions:

Does gender independently impact cardiovascular (CV) risk?

Methods:

The ONTARGET (Ongoing Telmisartan Alone and in Combination With Ramipril Global Endpoint Trial) and the parallel TRANSCEND (Telmisartan Randomised AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease) trials were used for the present analysis. ONTARGET (n = 25,620) and TRANSCEND (n = 5,926) recruited >30,000 patients, ages ≥55 years with high-risk CV disease, or diabetics with signs of end-organ damage, who were tolerant of (ONTARGET) or were intolerant of an angiotensin-converting enzyme (ACE) inhibitor (TRANSCEND). High risk of a major CV event was defined as one or more of the following: history of coronary artery disease, peripheral vascular disease, stroke or transient ischemic attack, or diabetes with end-organ complications. Differences in male versus female patients enrolled in ONTARGET/TRANSCEND were analyzed for the primary fourfold endpoint (composite of CV death, myocardial infarction [MI], stroke, or admission to hospital for heart failure [CHF]), a secondary threefold endpoint (CV death, MI, stroke), and individual components of the primary composite. Baseline characteristics included age, ethnicity, body mass index, physical activity, tobacco use, alcohol consumption, formal education, clinical diagnosis for study entry, patient history, and concomitant medication. Median follow-up period was 56 months.

Results:

A total of 9,378 women and 22,168 men from the ONTARGET and TRANSCEND studies were included in this analysis. Female participants were older and less physically active, whereas male participants were more likely to use tobacco and alcohol. Coronary artery disease was more frequent in the males; stroke was more frequent among the females. Female participants were also more likely to have diabetes and hypertension than the male participants. Female participants had a significantly lower risk for a combined endpoint of CV death, MI, stroke, or admission to the hospital for CHF (hazard ratio [HR], 0.81; 95% confidence interval [CI], 0.76-0.87). For the combined endpoint of CV death, MI, or stroke, the risk was also lower (21%) compared to male participants (HR, 0.79; 95% CI, 0.74-0.86). Both models were adjusted for study, treatment, and the above baseline characteristics. For the individual endpoints, CV death and MI, females had a lower risk compared with males. Risk for stroke or CHF hospitalization was similar between females and males. Among diabetics, females had a higher risk for MI compared to males. Alcohol consumption significantly lowered risk in female participants.

Conclusions:

The investigators concluded that an approximately 20% lower risk for CV disease events was observed among female participants compared with male participants, primarily in lower risk of MI.

Perspective:

The data include a larger proportion of female participants and demonstrate an overall lower risk for CV disease outcomes among the females. However, women with diabetes appear to have a higher risk for events compared to diabetic men.

Clinical Topics: Heart Failure and Cardiomyopathies, Vascular Medicine, Atherosclerotic Disease (CAD/PAD), Novel Agents, Heart Failure and Cardiac Biomarkers

Keywords: Coronary Artery Disease, Myocardial Infarction, Stroke, Follow-Up Studies, Ischemic Attack, Transient, Risk Factors, Peripheral Vascular Diseases, Benzoates, Peptidyl-Dipeptidase A, Benzimidazoles, Motor Activity, Cardiovascular Diseases, Tobacco Use, Diabetic Angiopathies, Diabetes Mellitus


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