Avanafil for the treatment of erectile dysfunction: a multicenter, randomized, double-blind study in men with diabetes mellitus

Abstract

Objective: To prospectively assess the safety and effectiveness of the investigational phosphodiesterase 5 inhibitor avanafil to treat erectile dysfunction in men with diabetes mellitus.

Patients and methods: This 12-week, multicenter, double-blind, placebo-controlled study conducted between December 15, 2008, and February 11, 2010, randomized 390 men with diabetes and erectile dysfunction 1:1:1 to receive avanafil, 100 mg (n=129), avanafil, 200 mg (n=131), or placebo (n=130). Coprimary end points assessed changes in the percentage of sexual attempts in which men were able to maintain an erection of sufficient duration to have successful intercourse (Sexual Encounter Profile [SEP] 3), percentage of sexual attempts in which men were able to insert the penis into the partner's vagina (SEP 2), and International Index of Erectile Function erectile function domain score.

Results: Compared with placebo, least-squares mean change from baseline to study end in SEP 3, SEP 2, and International Index of Erectile Function erectile function domain score were significantly improved with both avanafil, 100 mg (P≤.002), and avanafil, 200 mg (P<.001). Additional analyses indicated that successful intercourse could be initiated in 15 minutes or less through more than 6 hours after avanafil dosing. Adverse events most commonly reported with avanafil treatment were headache, nasopharyngitis, flushing, and sinus congestion.

Conclusion: Avanafil was safe and effective for treating erectile dysfunction in men with diabetes and was effective as early as 15 minutes and more than 6 hours after dosing. The adverse events seen with avanafil were similar to those seen with other phosphodiesterase 5 inhibitors.

Trial registration: clinicaltrials.gov Identifier NCT00809471.

FIGURE 1

Patient disposition in the study. In total, 1378 patients were enrolled in the study and 390 were assigned randomly to treatment. Of the 390 randomized patients, 333 completed the study and 57 discontinued participation. tx = treatment.

FIGURE 2

Effect of treatment between baseline and the treatment period on Sexual Encounter Profile (SEP) 3 (intent-to-treat [ITT] population) (A) and SEP 2 (ITT population) (B) and from baseline to the end of treatment on International Index of Erectile Function erectile function (IIEF-EF) domain score (ITT population) (C), normalization of IIEF-EF domain score (≥26) (ITT population) (D), and percentage of successful sexual attempts (SEP 3) over time after dosing (ITT last observation carried forward population) (E). *P<.001 vs baseline; ^†P=.009 vs baseline; ^‡P=.007 vs baseline.