Valiquette L, Montorsi F, Auerbach S
Department of Urology, Hôpital St-Luc du CHUM, Montréal, Québec, Canada.
Int J Clin Pract. 2006 Nov;60(11):1378-85. doi: 10.1111/j.1742-1241.2006.01170.x.
First-dose success of phosphodiesterase type 5 (PDE5) inhibitors may be adversely affected in patients with comorbidities. This article reports first-dose success rates for vardenafil 10 mg in men with erectile dysfunction (ED) and associated comorbidities who participated in the challenge phase of the Reliability--Vardenafil for Erectile Dysfunction I study. This study involved an open-label, single-dose, 1-week challenge period where patients who achieved SEP-2 (penetration) success were randomised to vardenafil 10 mg or placebo for 12 weeks in a double-blind manner. The first-dose success rates for SEP-2 and SEP-3 (maintenance of erection to completion of intercourse) were stratified according to comorbidities. Safety was assessed using adverse events (AEs). Of 600 men who received a single 10 mg dose of vardenafil, 32% had hypertension, 16% had diabetes and 19% had dyslipidaemia. Vardenafil demonstrated overall effectiveness, including first-dose SEP-2 and SEP-3 success rates in patients with and without specific comorbidities. Initial overall success rates for SEP-2 and SEP-3 during the challenge phase were 87% and 74% respectively. First-dose SEP-2 and SEP-3 success rates were 84% and 66% in men with hypertension (n = 191); 84% and 72% in men with dyslipidaemia (n = 116); and 75% and 58% in men with diabetes (n = 95). Vardenafil was well tolerated and most AEs, including the most frequently reported flushing (3.5%), were mild to moderate in intensity. Vardenafil 10 mg is generally well tolerated and efficacious, providing first-dose success with a consistently high rate of reliability of penetration and maintenance of erection in men with ED and associated comorbidities.
5型磷酸二酯酶（PDE5）抑制剂的首剂成功率可能会受到合并症患者的不利影响。本文报告了参与“伐地那非治疗勃起功能障碍的可靠性I研究”挑战阶段的勃起功能障碍（ED）合并相关疾病男性患者使用10mg伐地那非的首剂成功率。该研究包括一个开放标签、单剂量、为期1周的挑战期，在此期间达到SEP-2（插入）成功的患者以双盲方式随机分配至10mg伐地那非组或安慰剂组，持续12周。根据合并症对SEP-2和SEP-3（勃起维持至性交完成）的首剂成功率进行分层。使用不良事件（AE）评估安全性。在接受单次10mg伐地那非剂量的600名男性中，32%患有高血压，16%患有糖尿病，19%患有血脂异常。伐地那非显示出总体有效性，包括有特定合并症和无特定合并症患者的首剂SEP-2和SEP-3成功率。挑战阶段SEP-2和SEP-3的初始总体成功率分别为87%和74%。高血压男性（n = 191）的首剂SEP-2和SEP-3成功率分别为84%和66%；血脂异常男性（n = 116）为84%和72%；糖尿病男性（n = 95）为75%和58%。伐地那非耐受性良好且大多数不良事件，包括最常报告的潮红（3.5%），强度为轻度至中度。10mg伐地那非总体耐受性良好且有效，为患有ED及相关合并症的男性提供首剂成功，插入和勃起维持的可靠性持续保持高比率。
