A randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of avanafil in subjects with erectile dysfunction.

摘要: ABSTRACT Introduction Phosphodiesterase type 5 (PDE5) inhibitors have become standard treatment for erectile dysfunction (ED). Aim To prospectively evaluate the safety and efficacy of avanafil, a novel PDE5 inhibitor, in men with mild to severe ED. Methods In this multicenter, double‐blind, Phase 3 trial, 646 subjects were randomized receive avanafil (50 mg, 100 mg, 200 mg) or placebo throughout 12‐week period. Subjects instructed take study drug 30 minutes prior initiation sexual activity. At least 12‐hour separation time between doses was required; no restrictions placed on food alcohol intake. Main Outcome Measures Improvement function (EF) measured by Sexual Encounter Profile questions 2 (SEP2 SEP3) EF domain International Index Erectile Function (IIEF) questionnaire. Results Mean change percentage successful attempts IIEF‐EF score significantly favored all over ( P  ≤ 0.001). Secondary analyses demonstrated achievement intercourse within 15 minutes dosing. Of 300 made during interval, 64% 71% avanafil‐treated compared 27% placebo‐treated subjects. Successful also >6 hours post dosing, 59% 83% 80 25% The most commonly reported adverse events taking included headache, flushing, nasal congestion; there drug‐related serious events. Conclusion Following 12 weeks without restrictions, significant improvements observed placebo. as early after dosing some Avanafil generally well tolerated Goldstein I, McCullough AR, Jones LA, Hellstrom WJ, Bowden CH, DiDonato K, Trask B, Day WW. A randomized, placebo‐controlled evaluation dysfunction. J Sex Med 12;9:1122–1133.