Sexual Medicine, Alvarado Hospital, San Diego, CA 92120, USA.
J Sex Med. 2012 Apr;9(4):1122-33. doi: 10.1111/j.1743-6109.2011.02629.x. Epub 2012 Jan 16.
Phosphodiesterase type 5 (PDE5) inhibitors have become standard treatment for erectile dysfunction (ED).
To prospectively evaluate the safety and efficacy of avanafil, a novel PDE5 inhibitor, in men with mild to severe ED.
In this multicenter, double-blind, Phase 3 trial, 646 subjects were randomized to receive avanafil (50 mg, 100 mg, 200 mg) or placebo throughout a 12-week treatment period. Subjects were instructed to take study drug 30 minutes prior to initiation of sexual activity. At least a 12-hour separation time between doses was required; no restrictions were placed on food or alcohol intake.
Improvement in erectile function (EF) was measured by Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3) and by the EF domain of the International Index of Erectile Function (IIEF) questionnaire.
Mean change in percentage of successful sexual attempts (SEP2 and SEP3) and IIEF-EF domain score significantly favored all doses of avanafil over placebo (P ≤ 0.001). Secondary analyses demonstrated achievement of successful intercourse by subjects within 15 minutes of dosing. Of the 300 sexual attempts made during this interval, 64% to 71% were successful in avanafil-treated subjects compared with 27% in placebo-treated subjects. Successful intercourse was also demonstrated >6 hours post dosing, with 59% to 83% of the 80 sexual attempts successful in avanafil-treated subjects compared with 25% of placebo-treated subjects. The most commonly reported adverse events in subjects taking avanafil included headache, flushing, and nasal congestion; there were no drug-related serious adverse events.
Following 12 weeks of avanafil treatment without food or alcohol restrictions, significant improvements in sexual function were observed with all 3 doses of avanafil compared with placebo. Successful intercourse was observed as early as 15 minutes and >6 hours after dosing in some subjects. Avanafil was generally well tolerated for the treatment of ED.
磷酸二酯酶 5 型（PDE5）抑制剂已成为治疗勃起功能障碍（ED）的标准治疗方法。
前瞻性评估新型 PDE5 抑制剂阿伐那非治疗轻度至重度 ED 男性的安全性和疗效。
在这项多中心、双盲、3 期临床试验中，646 名受试者被随机分配至接受阿伐那非（50mg、100mg、200mg）或安慰剂治疗，为期 12 周。受试者被指示在开始性行为前 30 分钟服用研究药物。两次给药之间至少间隔 12 小时；不限制食物或酒精摄入。
通过性经历调查问卷 2 和 3（SEP2 和 SEP3）和国际勃起功能指数问卷（IIEF）的 EF 域评估勃起功能（EF）改善情况。
阿伐那非各剂量组的性成功尝试（SEP2 和 SEP3）和 IIEF-EF 域评分的平均变化明显优于安慰剂组（P≤0.001）。二次分析显示，在给药后 15 分钟内，有受试者完成了成功的性交。在这一间隔内进行的 300 次性尝试中，64%至 71%的阿伐那非治疗组成功，而安慰剂治疗组为 27%。在给药后 6 小时以上也证明了成功的性交，80 次性尝试中，阿伐那非治疗组有 59%至 83%成功，而安慰剂治疗组为 25%。服用阿伐那非的受试者最常见的不良反应包括头痛、潮红和鼻塞；无药物相关严重不良事件。
在没有食物或酒精限制的情况下接受 12 周的阿伐那非治疗后，与安慰剂相比，所有 3 种剂量的阿伐那非均显著改善了性功能。在一些受试者中，最早在 15 分钟和给药后 6 小时以上就观察到了成功的性交。阿伐那非治疗 ED 通常具有良好的耐受性。
