Comparing vardenafil and sildenafil in the treatment of men with erectile dysfunction and risk factors for cardiovascular disease: a randomized, double-blind, pooled crossover study.
Comparing vardenafil and sildenafil in the treatment of men with erectile dysfunction and risk factors for cardiovascular disease: a randomized, double-blind, pooled crossover study.
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比较伐地那非和西地那非治疗男性勃起功能障碍和心血管疾病危险因素：一项随机、双盲、汇总交叉研究。
DOI：
10.1111/j.1743-6109.2006.00310.x
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发表时间：
2006
影响因子：
3.5
通讯作者：
I. Goldstein
中科院分区：
文献类型：
--
作者：
E. Rubio;H. Porst;I. Eardley;I. Goldstein
引言
来自磷酸二酯酶5(PDE5)抑制剂的面对面临床试验的数据很少，这使得临床医生很难区分这些药物来为他们的勃起功能障碍(ED)患者选择最合适的治疗方法。
目标
这项随机、双盲、交叉、面对面的临床试验比较了伐地那非和西地那非在患有勃起功能障碍、糖尿病、高血压和/或高脂血症的男性中的患者偏好、疗效和安全性。
方法
对两项研究进行了前瞻性分析，其中1057名男性被随机分为伐地那非20 mg(N=530)或西地那非100 mg(2x50 mg胶囊)(N=527)，为期4周。经过1周的洗涤后，患者更换治疗4周。
主要结果衡量标准
患者被问及总体偏好：“总体来说，你更喜欢哪种药物？”，以及其他11个与他们的ED治疗相关的偏好问题。每个疗程后的疗效评估包括勃起功能国际指数(IIEF)的勃起功能(EF)领域评分；性接触概况(SEP)日记问题SEP2和SEP3；全球评估问题(GAQ)和治疗满意度量表(TSS)。在整个研究过程中收集了有关不良事件的数据。
结果
共有931名男性(平均年龄57.9岁)包括在意向治疗(ITT)人群中。在总体偏好方面，伐地那非非劣于西地那非(38.9%；西地那非34.5%；无偏好26.6%)。此外，IIEF的EF领域分数较基线的变化对伐地那非比西地那非具有名义意义(10.00vs.9.40；P=0.0052)。患者在SEP2、SEP3、GAQ和TSS的19个问题中有12个问题对伐地那非有较高的阳性反应率。两种药物的耐受性都很好。
结论
这项在有心血管危险因素的ED患者中进行的随机、双盲、面对面的试验表明，伐地那非的总体偏好并不逊色。在几个常用的疗效指标上，伐地那非在名义上取得了比西地那非更好的统计优势。两种药物的耐受性都很好。
INTRODUCTION
Data from head-to-head clinical trials of phosphodiesterase type 5 (PDE5) inhibitors are scarce, making it difficult for clinicians to differentiate among these agents to select the most appropriate treatment for their patients with erectile dysfunction (ED).
AIM
This randomized, double-blind, crossover head-to-head clinical trial compared patient preference, efficacy, and safety of vardenafil and sildenafil in men with ED and diabetes, hypertension, and/or hyperlipidemia.
METHODS
Prospective analysis was performed on two studies in which 1,057 men were randomized to vardenafil 20 mg (N = 530) or sildenafil 100 mg (2 x 50 mg encapsulated tablets) (N = 527) for 4 weeks. Following a 1-week washout, patients switched treatment for 4 weeks.
MAIN OUTCOME MEASURES
Patients were asked about overall preference: "Overall, which medication do you prefer?", plus 11 other preference questions relating to their ED treatment. Efficacy assessments after each treatment period included the erectile function (EF) domain score of the International Index of Erectile Function (IIEF); Sexual Encounter Profile (SEP) diary questions SEP2 and SEP3; Global Assessment Question (GAQ); and Treatment Satisfaction Scale (TSS). Data regarding adverse events were collected throughout the study.
RESULTS
A total of 931 men (mean age 57.9 years) were included in the intent-to-treat (ITT) population. Non-inferiority of vardenafil over sildenafil was achieved for overall preference (vardenafil 38.9%; sildenafil 34.5%; and no preference 26.6%). Additionally, the change from baseline in the EF domain score of the IIEF achieved nominal significance for vardenafil over sildenafil (10.00 vs. 9.40; P = 0.0052). Patients also had a higher percentage of positive responses for vardenafil for SEP2, SEP3, GAQ, and 12 of 19 questions on the TSS. Both drugs were well tolerated.
CONCLUSIONS
This randomized, double-blind, head-to-head trial in ED patients with cardiovascular risk factors demonstrated noninferiority of vardenafil for overall preference. Vardenafil achieved nominal statistical superiority over sildenafil for several frequently used efficacy measures. Both drugs were well tolerated.