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首页> 外文期刊>The journal of sexual medicine >A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Avanafil in Subjects with Erectile Dysfunction
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A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Avanafil in Subjects with Erectile Dysfunction

机译：阿瓦那非在勃起功能障碍患者中的​​安全性和有效性的随机，双盲，安慰剂对照评估

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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 to receive avanafil (50mg, 100mg, 200mg) or placebo throughout a 12-week treatment period. Subjects were instructed to take study drug 30minutes 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. Main Outcome Measures. 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. Results. 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. Conclusion. 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.
机译：介绍。 5型磷酸二酯酶（PDE5）抑制剂已成为勃起功能障碍（ED）的标准治疗方法。目标。为了前瞻性评估新型PDE5抑制剂avanafil在轻度至重度ED患者中的安全性和疗效。方法。在这项多中心，双盲，3期试验中，将646名受试者随机分配为在12周的治疗期内接受阿伐那非（50mg，100mg，200mg）或安慰剂。指示受试者在开始性活动前30分钟服用研究药物。两次剂量之间至少需要12小时的间隔时间;对食物或酒精的摄入没有限制。主要观察指标。通过性接触情景问题2和3（SEP2和SEP3）以及国际勃起功能指数（IIEF）问卷调查的EF域来衡量勃起功能（EF）的改善。结果。成功进行性尝试的百分比（SEP2和SEP3）和IIEF-EF域得分的平均变化显着优于所有剂量的avanafil而非安慰剂（P≤0.001）。次要分析表明受试者在给药后15分钟内成功完成性交。在此间隔内进行的300次性尝试中，使用avanafil治疗的受试者成功完成了64％至71％，而使用安慰剂治疗的受试者成功完成了27％。在给药后6小时内也证实了成功的性交，在接受阿伐那非治疗的受试者中，有80次性尝试成功，其中有59％至83％，而由安慰剂治疗的受试者中有25％。服用avanafil的受试者中最常见的不良反应包括头痛，潮红和鼻充血。没有与药物有关的严重不良事件。结论。在无食物或酒精限制的情况下接受阿伐那非治疗12周后，与安慰剂相比，所有3剂量的阿伐那非均观察到性功能显着改善。在某些受试者中，在服药后15分钟和> 6小时观察到成功的性交。阿伐那非对ED的治疗通常耐受性良好。

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