灵活剂量伐地那非（艾力达）在广大欧洲男性群体中的疗效与安全性。

The efficacy and safety of flexible-dose vardenafil (levitra) in a broad population of European men.

作者信息

Hatzichristou Dimitrios, Montorsi Francesco, Buvat Jacques, Laferriere Nicole, Bandel Tiemo-Joerg, Porst Hartmut

机构信息

Department of Urology and Center for Sexual and Reproductive Health, Aristotle University of Thessaloniki, 77 Mitropoleos str., 546 22 Thessaloniki, Greece.

出版信息

Eur Urol. 2004 May;45(5):634-41; discussion 641. doi: 10.1016/j.eururo.2004.01.014.

DOI:10.1016/j.eururo.2004.01.014

PMID:15082207

Abstract

BACKGROUND

In fixed-dose studies, vardenafil 5, 10, and 20mg improves erectile function in men with erectile dysfunction (ED). Here, the efficacy and tolerability of vardenafil when used in a flexible-dose regimen was assessed.

METHODS

In this multicenter trial, 323 patients randomly received vardenafil 10mg or placebo. After 4 weeks, patients could switch to 5 or 20mg (or corresponding placebo), or remain on 10mg for an additional 4 weeks; dose-switching was optional for the last 4 weeks. Efficacy variables included the IIEF-EF domain score, GAQ, and percentage of positive responses to SEP2/SEP3 questions.

RESULTS

The IIEF-EF domain score significantly improved from a baseline of moderate ED (12.6-13.1) to mild ED in men on vardenafil (21.0-24.2) compared with placebo (13.7-15.6) at weeks 4, 8, 12, and last observation carried forward (LOCF) (p<0.005 vs. placebo). A significantly greater proportion of men receiving vardenafil at weeks 4, 8, 12, and LOCF reported improved erections (80-86% vs. 21-36% for placebo, p<0.005). Successful SEP2 rates increased after vardenafil, reaching 84% at weeks 8 and 12 vs. 49-53% receiving placebo (p<0.005 vs. placebo). Vardenafil improved successful SEP3 rates ranging from 58% to 74% compared to 22-34% for placebo. The most common adverse events, flushing and headache, were generally mild and transient.

CONCLUSION

In this flexible dose study, vardenafil was well-tolerated, and produced clinically relevant improvements in erectile function in men with ED.

摘要

背景

在固定剂量研究中，伐地那非5毫克、10毫克和20毫克可改善勃起功能障碍（ED）男性的勃起功能。在此，评估了伐地那非在灵活剂量方案中的疗效和耐受性。

方法

在这项多中心试验中，323名患者随机接受伐地那非10毫克或安慰剂。4周后，患者可换用5毫克或20毫克（或相应安慰剂），或继续服用10毫克再持续4周；在最后4周可选择换药。疗效变量包括国际勃起功能指数-勃起功能（IIEF-EF）领域评分、总体评估问卷（GAQ）以及对SEP2/SEP3问题的阳性反应百分比。

结果

与安慰剂组（第4、8、12周及末次观察结转（LOCF）时为13.7 - 15.6）相比，服用伐地那非的男性患者的IIEF-EF领域评分从基线时的中度ED（12.6 - 13.1）显著改善为轻度ED（21.0 - 24.2）（与安慰剂相比，p<0.005）。在第4、8、12周及LOCF时，服用伐地那非的男性报告勃起改善的比例显著更高（80 - 86%，而安慰剂组为21 - 36%，p<0.005）。服用伐地那非后，SEP2成功率增加，在第8周和12周达到84%，而服用安慰剂的患者为49 - 53%（与安慰剂相比，p<0.005）。与安慰剂组的22 - 34%相比，伐地那非使SEP3成功率提高至58%至74%。最常见的不良事件潮红和头痛通常较轻且为一过性。