Safety and Efficacy of Vardenafil, a Selective Phosphodiesterase 5 Inhibitor, in Patients with Erectile Dysfunction and Arterial Hypertension Treated with Multiple Antihypertensives

ABSTRACT Introduction Vardenafil, a phosphodiesterase type 5 (PDE5) inhibitor, was evaluated in a prospective trial in the primary care setting involving hypertensive men with ED who were receiving at least one antihypertensive medication. Aims To investigate the safety and efficacy of flexible‐dose vardenafil therapy compared with placebo in PDE5 inhibitor‐naive subjects with arterial hypertension and ED. Methods In this multicenter, randomized, double‐blind, placebo‐controlled study, 354 patients received placebo or vardenafil (5–20 mg) for 12 weeks. Primary efficacy measures were diary responses to the Sexual Encounter Profile (SEP) questions 2 (vaginal insertion) and 3 (maintenance of erection). Additional efficacy measures included positive responses to the Global Assessment Question (GAQ). Results Compared with placebo, vardenafil significantly improved mean SEP2 and SEP3 success rates over the 12‐week study period (intention‐to‐treat [ITT] and last observation carried forward [LOCF]) analysis). For LOCF, SEP2 and SEP3 were 83% for vardenafil vs. 58% for placebo and 67% for vardenafil vs. 35% for placebo, respectively ( P P Conclusion Vardenafil significantly improves EF in hypertensive men treated with concomitant antihypertensive medication, is well tolerated, and does not significantly affect blood pressure. van Ahlen H, Wahle K, Kupper W, Yassin A, Reblin T, and Neureither M. Safety and efficacy of vardenafil, a selective phosphodiesterase 5 inhibitor, in patients with erectile dysfunction and arterial hypertension treated with multiple antihypertensives. J Sex Med 2005;2:856–864.