Cheng Eric
Department of Family Medicine, State University of New York, Health Science Center, Brooklyn, New York, USA.
J Sex Med. 2007 Mar;4(2):432-9. doi: 10.1111/j.1743-6109.2006.00383.x. Epub 2006 Nov 6.
Clinical trials show that vardenafil produces effective and satisfactory first-dose success rates and reliability for erection and intercourse in men with erectile dysfunction (ED).
This study was conducted to evaluate real-life efficacy, safety, and acceptance of vardenafil in men with ED.
This open-label, prospective study, conducted in 6,740 U.S. centers, included an initial visit and one or two follow-up visits within a 2-month period of the first vardenafil dose. Vardenafil was administered in 5-20 mg doses.
Efficacy variables included first-dose success rates for vaginal penetration, maintenance of erection, and satisfaction based on physician and patient assessments. Safety was assessed by adverse events (AEs).
A total of 30,010 men were included in the safety/intent-to-treat (S/ITT) analysis, with 26,043 men in the adjusted S/ITT population. Vardenafil improved erectile function in 78% of men, with 75% rating overall efficacy as "satisfying" or "very satisfying." The overall rates of successful penetration and maintenance with vardenafil following the first dose were 78% and 68%, respectively. For men with mild and moderate ED, first-dose success rates for penetration were 89% and 82%, respectively, and for maintenance, 82% and 71%, respectively. First-dose penetration and maintenance of erection rates were 76% and 66%, respectively, for men with self-reported hypertension, and 70% and 60%, respectively, for men with diabetes mellitus. At study end, 67% of patients preferred to continue using vardenafil. The most frequently reported AEs were headache (4%) and flushing (2%). Vardenafil was well tolerated, with a "satisfied/very satisfied" tolerability rating in 75% of cases as assessed by the physician.
This observational study demonstrated the tolerability and efficacy of vardenafil in men with ED and comorbidities. Vardenafil provided a high rate of first-dose intercourse success and a favorable safety profile in patients with and without comorbid disease.
临床试验表明，伐地那非对勃起功能障碍（ED）男性的勃起和性交具有有效且令人满意的首剂成功率及可靠性。
本研究旨在评估伐地那非在ED男性中的实际疗效、安全性及接受度。
这项开放标签的前瞻性研究在美国6740个中心开展，包括首次就诊以及在首次服用伐地那非后的2个月内进行一到两次随访。伐地那非的给药剂量为5 - 20毫克。
疗效变量包括基于医生和患者评估的阴道插入首剂成功率、勃起维持率及满意度。通过不良事件（AE）评估安全性。
共有30010名男性纳入安全性/意向性治疗（S/ITT）分析，26043名男性纳入调整后的S/ITT人群。伐地那非使78%的男性勃起功能得到改善，75%的人将总体疗效评为“满意”或“非常满意”。首次给药后伐地那非成功插入和维持勃起的总体发生率分别为78%和68%。对于轻度和中度ED男性，插入的首剂成功率分别为89%和82%，维持勃起的首剂成功率分别为82%和71%。自我报告患有高血压的男性，勃起插入和维持的首剂成功率分别为76%和66%，患有糖尿病的男性分别为70%和60%。在研究结束时，67%的患者更愿意继续使用伐地那非。最常报告的不良事件为头痛（4%）和潮红（2%）。伐地那非耐受性良好，医生评估显示75%的病例耐受性评级为“满意/非常满意”。
这项观察性研究证明了伐地那非在伴有合并症的ED男性中的耐受性和疗效。伐地那非在有或无合并症的患者中均提供了较高的首剂性交成功率及良好的安全性。
