LISBON—Avanafil, an investigational, highly specific phosphodiesterase type 5 inhibitor, is an effective treatment for erectile dysfunction (ED) in men with diabetes, according to phase 3 data released at the 47th European Association for the Study of Diabetes annual meeting.
“Considering that diabetics have a high incidence of ED, avanafil may provide an additional therapeutic option,” Irwin Goldstein, MD, Director of San Diego Sexual Medicine at Alvarado Hospital, and colleagues wrote in a poster presentation.
In men with diabetes, the prevalence of ED has been reported to exceed 70%.
For their study, the investigators randomized 390 men with type 1 or 2 diabetes and mild-to-severe ED of more than six months’ duration to receive either placebo, avanafil 100 mg, or avanafil 200 mg for on-demand use for 12 weeks. To be included in the study, men needed to have four documented attempts at sexual intercourse, a 50% or greater failure rate in maintaining an erection of sufficient duration for sexual intercourse, and an International Index of Erectile Function (IIEF))-erectile function (EF) domain score of 5-25.
Subjects were instructed to take the study drug about 30 minutes before the start of sexual activity and could take up to two doses within a 24-hour period. They had no restrictions on the timing of food or alcohol intake, and concurrent alpha-blocker use was also allowed.
Both doses of avanafil produced significant improvements over placebo in co-primary outcome measures. For example, 36% of placebo-treated patients had successful penetration attempts at baseline compared with 42% afterwards. The corresponding figures were 32.5% and 54.0% in men receiving avanafil 100 mg, and 41.5% and 63.5% in men receiving avanafil 200 mg.
Overall, 10% of placebo-treated men had successful intercourse attempts before treatment compared with 20.5% afterwards. The corresponding figures were 8.2% and 34.4% for men receiving avanafil 100 mg and 8.0% and 40% for men receiving avanafil 200 mg.
Improvements on the IIEF-EF domain score were also superior with both doses of avanafil.
Avanafil was effective as early as 15 minutes and in some subjects beyond six hours after dosing.
The agent was well tolerated. The most common adverse events in the avanafil treatment groups were headache, nasopharyngitis, flushing, and sinus congestion.