伐地那非对勃起功能障碍男性患者长期提供可靠疗效。

Vardenafil provides reliable efficacy over time in men with erectile dysfunction.

作者信息

Montorsi Francesco, Hellstrom Wayne J G, Valiquette Luc, Bastuba Martin, Collins Owen, Taylor Terry, Thibonnier Marc, Homering Martin, Eardley Ian

机构信息

Instituto San Raffaele, Milan, Italy.

出版信息

Urology. 2004 Dec;64(6):1187-95. doi: 10.1016/j.urology.2004.07.032.

DOI:10.1016/j.urology.2004.07.032

PMID:15596195

Abstract

OBJECTIVES

To evaluate the reliability of vardenafil efficacy and tolerability within 12 weeks in a broad population of men with erectile dysfunction (ED).

METHODS

In a retrospective analysis of two pivotal, Phase III, randomized, double-blind, placebo-controlled trials conducted in 107 centers, 1650 men aged 18 years or older with ED received vardenafil 5 mg, 10 mg, or 20 mg on demand for 12 to 26 weeks. Outcome measures included the first-time and subsequent overall success rate until week 12 for diary entries regarding vaginal penetration (Sexual Encounter Profile [SEP]-2), erection maintenance (SEP-3), satisfaction with erection hardness, and overall satisfaction with the sexual experience. Mean efficacy was calculated for each patient during 12 weeks and then averaged for all patients within each treatment group.

RESULTS

At baseline, the intention-to-treat population had moderate ED (International Index of Erectile Function-Erectile Function domain score of 13). For SEP-2 (penetration), the first-attempt and subsequent success rate was 44% and 74% for placebo, 71% and 81% for vardenafil 5 mg, 76% and 86% for vardenafil 10 mg, and 76% and 91% for vardenafil 20 mg, respectively. For SEP-3 (maintenance), first-attempt and subsequent success rate was 25% and 56% for placebo, 51% and 76% for vardenafil 5 mg, 65% and 76% for vardenafil 10 mg, and 59% and 84% for vardenafil 20 mg, respectively. For overall satisfaction with the sexual experience, the first-attempt and subsequent success rate was 19% and 48% for placebo, 48% and 68% for vardenafil 5 mg, 57% and 72% for vardenafil 10 mg, and 56% and 79% for vardenafil 20 mg, respectively. The reliability of vardenafil was similar or slightly greater in sildenafil-naive subjects compared with prior sildenafil responders. The most common adverse events were mild-to-moderate headache, flushing, and rhinitis.

CONCLUSIONS

Vardenafil provides reliable efficacy for key erectile function parameters important to patients when continuing oral treatment for ED.

摘要

目的

评估伐地那非在12周内对广大勃起功能障碍（ED）男性患者疗效和耐受性的可靠性。

方法

对在107个中心进行的两项关键的III期随机、双盲、安慰剂对照试验进行回顾性分析，1650名18岁及以上的ED男性患者按需服用5毫克、10毫克或20毫克伐地那非，持续12至26周。结果指标包括直至第12周关于阴道插入（性接触概况[SEP]-2）、勃起维持（SEP-3）、对勃起硬度的满意度以及对性体验的总体满意度的首次及后续总体成功率。计算每位患者12周内的平均疗效，然后对每个治疗组内的所有患者求平均值。

结果

在基线时，意向性治疗人群患有中度ED（国际勃起功能指数-勃起功能领域评分为13）。对于SEP-2（插入），安慰剂组的首次尝试及后续成功率分别为44%和74%，伐地那非5毫克组为71%和81%，伐地那非10毫克组为76%和86%，伐地那非20毫克组为76%和91%。对于SEP-3（维持），安慰剂组的首次尝试及后续成功率分别为25%和56%，伐地那非5毫克组为51%和76%，伐地那非10毫克组为65%和76%，伐地那非20毫克组为59%和84%。对于性体验的总体满意度，安慰剂组的首次尝试及后续成功率分别为19%和48%，伐地那非5毫克组为48%和68%，伐地那非10毫克组为57%和72%，伐地那非20毫克组为56%和79%。与先前服用西地那非有反应的受试者相比，在未服用过西地那非的受试者中伐地那非的可靠性相似或略高。最常见的不良事件为轻至中度头痛、潮红和鼻炎。