Giuliano F, Rubio-Aurioles E, Kennelly M, Montorsi F, Kim E D, Finkbeiner A E, Pommerville P J, Colopy M W, Wilkins H J, Wachs B H
Department of Urology, Academic Hospital of Bicêtre, Le Kremlin Bicêtre, France.
Neurology. 2006 Jan 24;66(2):210-6. doi: 10.1212/01.wnl.0000194260.43583.32.
To assess the efficacy and tolerability of vardenafil in men with erectile dysfunction (ED) due to traumatic spinal cord injury (SCI).
In this multicenter, double-blind, placebo-controlled, parallel-group 12-week study, 418 men aged 18 years and older with ED for more than 6 months consequent to SCI were randomized to vardenafil (n = 207) or placebo (n = 211) (10 mg for 4 weeks, then maintained or titrated to 5 or 20 mg at weeks 4 and 8). Efficacy assessments included the erectile function (EF) domain score of the International Index of Erectile Function questionnaire and diary questions regarding penetration, maintenance of erection to completion of intercourse, and ejaculation.
Baseline patient characteristics were similar in the vardenafil (mean age 40 years) and placebo (mean age 39 years) groups. Mean baseline EF domain scores were 11.6 in the vardenafil group and 12.1 (moderate ED) in the placebo group. EF domain score in the vardenafil group improved to 22.0 (mild ED) at last observation carried forward vs 13.5 in the placebo group (p < 0.001). Over 12 weeks of treatment, mean per-patient penetration (76% vs 41%), maintenance (59% vs 22%), and ejaculation (19% vs 10%) success rates were significantly greater vs placebo (all p < 0.001). The most frequently reported drug-related adverse events were headache (vardenafil 15%, placebo 4%), flushing (vardenafil 6%, placebo 0%), nasal congestion (vardenafil 5%, placebo 0%), and dyspepsia (vardenafil 4%, placebo 0%).
Vardenafil significantly improved erectile and ejaculatory function and was generally well tolerated in men with erectile dysfunction due to spinal cord injury.
评估伐地那非对创伤性脊髓损伤（SCI）所致勃起功能障碍（ED）男性患者的疗效和耐受性。
在这项多中心、双盲、安慰剂对照、平行组12周研究中，418名年龄在18岁及以上、因SCI导致ED超过6个月的男性被随机分为伐地那非组（n = 207）或安慰剂组（n = 211）（10 mg服用4周，然后在第4周和第8周维持或滴定至5 mg或20 mg）。疗效评估包括国际勃起功能指数问卷的勃起功能（EF）领域评分以及关于插入、勃起维持至性交完成和射精的日记问题。
伐地那非组（平均年龄40岁）和安慰剂组（平均年龄39岁）的基线患者特征相似。伐地那非组的平均基线EF领域评分为11.6，安慰剂组为12.1（中度ED）。末次观察结转时，伐地那非组的EF领域评分改善至22.0（轻度ED），而安慰剂组为13.5（p < 0.001）。在12周的治疗中，与安慰剂相比，每位患者的平均插入成功率（76%对41%）、维持成功率（59%对22%）和射精成功率（19%对10%）均显著更高（所有p < 0.001）。最常报告的与药物相关的不良事件为头痛（伐地那非15%，安慰剂4%）、潮红（伐地那非6% ，安慰剂０%）、鼻塞（伐地那非5%，安慰剂0%）和消化不良（伐地那非4%，安慰剂0%）。
伐地那非显著改善了脊髓损伤所致勃起功能障碍男性患者的勃起和射精功能，且总体耐受性良好。
