Vardenafil provides reliable efficacy over time in men with erectile dysfunction
Vardenafil provides reliable efficacy over time in men with erectile dysfunction
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DOI：
10.1016/j.urology.2004.07.032
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发表时间：
2004-12-01
期刊：
影响因子：
2.1
通讯作者：
Eardley, I
中科院分区：
文献类型：
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作者：
Montorsi, F;Hellstrom, WJG;Eardley, I
目标.评价伐地那非治疗勃起功能障碍（艾德）男性患者12周内疗效和耐受性的可靠性。在107个中心进行的两项关键性、III期、随机、双盲、安慰剂对照试验的回顾性分析中，1650名18岁或18岁以上的艾德男性按需接受伐地那非5 mg、10 mg或20 mg治疗12至26周。结果指标包括第一次和随后的总体成功率，直到第12周，日记中关于阴道插入（性接触特征[SEP]-2）、勃起维持（SEP-3）、勃起硬度满意度和性体验总体满意度。计算12周内每例患者的平均疗效，然后计算每个治疗组内所有患者的平均值。基线时，意向治疗人群有中度艾德（国际勃起功能指数-勃起功能领域评分为13）。对于SEP-2（渗透），安慰剂组的首次尝试成功率和后续成功率分别为44%和74%，伐地那非5 mg组为71%和81%，伐地那非10 mg组为76%和86%，伐地那非20 mg组为76%和91%。对于SEP-3（维持治疗），安慰剂组首次尝试和后续成功率分别为25%和56%，伐地那非5 mg组为51%和76%，伐地那非10 mg组为65%和76%，伐地那非20 mg组为59%和84%。就性体验的总体满意度而言，安慰剂组的首次尝试和后续成功率分别为19%和48%，伐地那非5 mg组为48%和68%，伐地那非10 mg组为57%和72%，伐地那非20 mg组为56%和79%。与既往西地那非应答者相比，西地那非初治受试者中伐地那非的可靠性相似或略高。最常见的不良反应是轻度至中度头痛、潮红和鼻炎。伐地那非在持续口服治疗ED时对患者重要的关键勃起功能参数提供可靠疗效。（C）2004 Elsevier Inc.
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% and81% 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. (C) 2004 Elsevier Inc.