Erectile dysfunction (ED) is a common disorder in middle-aged men and is significantly influenced by cardiovascular risk factors (CVRFs) and cardiovascular disease. The substudy of the ONTARGET/TRANSCEND trials evaluates the relationship of erectile function to baseline characteristics and current treatment in cardiovascular high-risk patients who have been enrolled in these trials. The effects of treatment with telmisartan and ramipril, alone or in combination, including a telmisartan versus placebo arm will be determined prospectively during a follow-up of 4 years.

One thousand three hundred fifty-seven patients were evaluated in 13 countries at baseline, 2 years, and 4 years, with ED determined using the ED score of the Cologne Male Survey (Kölner [Cologne] Evaluation of Erectile Dysfunction) and the 5-item International Index of Erectile Function. Erectile dysfunction scores were related to CVRF and the use of cardiovascular drugs.

Prevalence of ED was 50.7% (Kölner [Cologne] Evaluation of Erectile Dysfunction) and 54.3% (5-item International Index of Erectile Function), respectively, with a decline of sexual activity after the diagnosis of cardiovascular disease. In multivariate analysis, diabetes mellitus (P < .00001), stroke (P = .00026), pelvic surgery (P = .025), and age of >65 years (P < .00001) correlated with the degree of ED. No significant associations were observed for cholesterol levels, hypertension, and smoking status as well as current treatment with angiotensin-converting enzyme inhibitors, angiotensin I antagonists, diuretics, β-blockers, or calcium-channel blockers.

The ONTARGET/TRANSCEND-ED substudy shows a significant influence of cardiovascular disease on erectile function. In contrast to prior smaller studies, drug therapy and CVRF seem to play a minor role in cardiovascular high-risk patients. Follow-up data will provide information whether angiotensin-converting enzyme inhibitors, angiotensin I antagonists, or a combination thereof are able to improve erectile function.