To review the evidence evaluating the efficacy of vardenafil in subgroups of hypertensive patients with erectile dysfunction (ED). Meta-analysis of randomized, double-blinded, placebo-controlled, flexible-dose vardenafil clinical trials that were >or=12 weeks in duration evaluated men with a >or=6-month history of ED and required a >or=50% failure rate in baseline sexual attempts. The primary endpoints analyzed were the erectile function domain of the International Index of Erectile Function questionnaire (IIEF-EF) and Sexual Encounter Profile questions 2 (SEP2) and 3 (SEP3). Eight clinical trials were included (n = 2427 patients) consisting of 839 patients (35%) with a self-reported diagnosis of hypertension (HTN): 498 in the vardenafil and 341 in the placebo groups. Vardenafil's efficacy was evidenced by an average increase of 8.9 points in the IIEF-EF (95% CI: 7.4, 10.5) at week 12 compared to placebo, with individual trial values ranging from 16.4 to 26.1 and 11.3 to 17.8 for the vardenafil and placebo groups, respectively. Vardenafil also increased success rates for the ability to obtain erections (SEP2) by 32.4% (95% CI: 27.4%, 37.5%) over a 12-week timeframe compared to placebo, with individual trial values ranging from 57.2% to 92.2% for vardenafil and 32.0% to 66.9% for placebo. Similarly, success rates for the ability to maintain erections (SEP3) improved 38.0% (95% CI: 29.5%, 46.6%) compared to placebo, with individual trial values ranging from 41.7% to 88.2% for vardenafil and 20.5% to 51.4% for placebo. Vardenafil was equally efficacious in improving IIEF-EF, SEP2, and SEP3 in those with and without self-reported HTN. This meta-analysis demonstrated that vardenafil was significantly more efficacious than placebo for the treatment of ED in patients with comorbid HTN and offered similar treatment benefits in patients without HTN.