Vardenafil on Demand Compared With Tadalafil Administered 24 Hours Before Sexual Intercourse in Patients With ED.

Vardenafil on Demand Compared With Tadalafil Administered 24 Hours Before Sexual Intercourse in Patients With ED, Marianno Sotomayor, National Nutrition Institute, Mexico; Hermann Van Ahlen, Klinik fir Urologie and Kindernrologie, Germany; Andrea Salonia and Francesco Montorsi, Universita Vita Salute San Raffaele, Italy; Luis Rodriguez Vela, Hospital Miguel Servet, Spain; Tiemo Bandel, Ernst Ulbrich, and Manfred Beneke, Bayer Healthcare, Germany

In the Men's Attitudes to Life Events and Sexuality (MALES) 2004 study, couples usually engaged in sexual activity with little or no advance planning, within 1 hour of the decision to do so, and only once within 24 hours. Whether there is benefit in utility of long-acting PDE-5 inhibition is of interest since planning is required. The efficacy of vardenafil (VAR) vs. tadalafil (TAD) was assessed in context of sexual activity initiated soon after dosing with VAR compared with a time at which TAD is reportedly still efficacious. In this open-label, randomized, parallel-group, 4-week study, 614 men who had erectile dysfunction (ED) for more than 6 months received the recommended starting doses of VAR (10 mg) or TAD (10 mg) with instructions to initiate sexual activity 1 hour post-closing with VAR or 24 hours post-dosing with TAD. The primary efficacy variable was the mean per-patient rate of positive responses to the Sexual Encounter Profile (SEP) question regarding erection maintenance to intercourse completion (SEP3), observed 15 minutes to 4 hours and 22-26 hours in the VAR and TAD groups, respectively. Secondary variables included mean SEP3 responder rates. The mean baseline International Index of Erectile Function, erectile function (IIEF-EF) domain score (n = 598, ITT) was 12.7 (moderate ED). Patients receiving VAR experienced significantly superior mean-per-patient SEP3 success rates at 1 hour post-dose compared with patients receiving TAD when assessed 24 hours post-dose. Mean SEP3 responder rates were also higher in VAR- vs. TAD-treated patients at 1 hour and 24 hours, respectively. The most frequently reported adverse events in the VAR and TAD groups were headache and flushing. Overall, VAR, when used on demand, which is the predominant pattern of sexual behavior, provided significantly higher efficacy in intercourse success compared to TAD taken in advance.