Montorsi Francesco, Brock Gerald, Lee Jay, Shapiro JoAnn, Van Poppel Hendrik, Graefen Markus, Stief Christian
Division of Urology, Universita Vita Salute San Raffaele, Via Olgettina 60, Milan, Italy.
Eur Urol. 2008 Oct;54(4):924-31. doi: 10.1016/j.eururo.2008.06.083. Epub 2008 Jul 9.
To date, no data have been available from large, well-designed trials comparing on demand and nightly dosing of phosphodiesterase type 5 (PDE5) inhibitors on recovery of erectile function in postprostatectomy patients with erectile dysfunction (ED).
To investigate the effect of early postoperative dosing with vardenafil, administered either nightly or on demand, compared with placebo on recovery of erectile function in men with ED following bilateral nerve-sparing radical prostatectomy (NSRP) surgery.
DESIGN, SETTING, AND PARTICIPANTS: A randomised, double-blind, double-dummy, multicentre, parallel group study conducted at 87 centres across Europe, Canada, South Africa, and the United States. For inclusion, patients had to be scheduled to undergo bilateral NSRP within 1 mo of screening and have a normal International Index of Erectile Function erectile function domain (IIEF-EF) score of > or =26 at screening. A total of 628 men, aged 18-64 yr, were randomised to treatment. Study design consisted of a 9-mo double-blind treatment period, a 2-mo single-blind washout period, and an optional 2-mo open-label period.
Patients received placebo, nightly vardenafil, or on demand vardenafil.
Primary outcome measure was the percentage of subjects with an IIEF-EF score of > or =22 after the 2-mo washout period. Secondary variables included mean per-patient success rates for Sexual Encounter Profile (SEP) questions 2 and 3.
No statistically significant differences were observed among treatment groups in the proportion of patients with an IIEF-EF score of > or =22 or in SEP3 success rates after the washout period. On-demand vardenafil treatment resulted in significantly greater IIEF-EF scores and better SEP3 response rates than placebo over the entire treatment period.
In this study of men with ED following bilateral NSRP, vardenafil was efficacious when used on demand, supporting a paradigm shift towards on demand dosing with PDE5 inhibitors in this patient group.
European clinical trials database (EudraCT; available at http://eudract.emea.europa.eu/).
迄今为止，尚无来自大型、设计良好的试验的数据，比较按需服用和每晚服用5型磷酸二酯酶（PDE5）抑制剂对前列腺切除术后勃起功能障碍（ED）患者勃起功能恢复的影响。
研究早期术后服用伐地那非，每晚服用或按需服用，与安慰剂相比，对双侧保留神经根治性前列腺切除术（NSRP）术后ED男性勃起功能恢复的影响。
设计、设置和参与者：一项随机、双盲、双模拟、多中心、平行组研究，在欧洲、加拿大、南非和美国的87个中心进行。纳入标准为，患者必须在筛查后1个月内计划接受双侧NSRP，且筛查时国际勃起功能指数勃起功能领域（IIEF-EF）评分正常，≥26分。共有628名年龄在18-64岁的男性被随机分配接受治疗。研究设计包括9个月的双盲治疗期、2个月的单盲洗脱期和一个可选的2个月开放标签期。
患者接受安慰剂、每晚服用伐地那非或按需服用伐地那非。
主要结局指标是在2个月洗脱期后IIEF-EF评分≥22分的受试者百分比。次要变量包括性接触概况（SEP）问题2和3的每位患者平均成功率。
在洗脱期后，治疗组之间在IIEF-EF评分≥22分的患者比例或SEP3成功率方面未观察到统计学上的显著差异。在整个治疗期间，按需服用伐地那非治疗导致IIEF-EF评分显著更高，SEP3反应率比安慰剂更好。
在这项对双侧NSRP术后ED男性的研究中，按需服用伐地那非是有效的，支持在该患者群体中向按需服用PDE5抑制剂的模式转变。
欧洲临床试验数据库（EudraCT；可在http://eudract.emea.europa.eu/获取）。
11336。
