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首页> 外文期刊>The journal of sexual medicine >Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction in elderly men and those with underlying conditions: an integrated analysis of two pivotal trials.
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Efficacy and safety of an orodispersible vardenafil formulation for the treatment of erectile dysfunction in elderly men and those with underlying conditions: an integrated analysis of two pivotal trials.

机译：口服分散的伐地那非制剂对老年男性和有潜在疾病的勃起功能障碍的疗效和安全性：两项关键性试验的综合分析。

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INTRODUCTION: Men with erectile dysfunction (ED) are typically older and have one or more underlying cardiovascular conditions. AIM: To determine the efficacy and safety of a new orodispersible tablet (ODT) formulation of vardenafil for the treatment of ED, and whether age, or the presence of underlying conditions affects treatment outcomes. METHODS: This is an integrated analysis of data from two phase III, double-blind, multicenter, randomized, parallel-group, placebo-controlled studies that compared 10 mg on-demand vardenafil ODT with placebo in a general population of men with ED, stratified so that approximately 50% of patients were aged >/= 65 years. Results were reported by age (<6 5 vs. >/= 65 years) and presence/absence of diabetes, dyslipidemia, or hypertension. MAIN OUTCOME MEASURES: Primary measures were the erectile function domain of the International Index of Erectile Function (IIEF-EF) and Sexual Encounter Profile questions 2 (SEP2) and 3 (SEP3). RESULTS: Of the 701 men randomized (51% aged >/= 65 years), 686 were included in the intent-to-treat population (placebo, n = 334; vardenafil ODT, n = 352). Vardenafil ODT was significantly superior to placebo for all primary efficacy measures, regardless of age, baseline ED severity, or underlying condition (P < 0.0001 for vardenafil vs. placebo for each endpoint). IIEF-EF scores and SEP2/3 success rates in older patients and men with underlying conditions were not significantly different to those of younger patients or men without underlying conditions. Adverse events (AEs) were mostly mild to moderate in severity, occurring with higher incidence in the vardenafil vs. placebo group. The most frequently reported drug-related AEs in the vardenafil group were headache, flushing, nasal congestion, dizziness, and dyspepsia, consistent with the known safety profile of phosphodiesterase type 5 inhibitors. CONCLUSIONS: Vardenafil ODT significantly improves erectile function in men with ED regardless of age, baseline ED severity, or underlying condition.
机译：简介：患有勃起功能障碍（ED）的男性通常年龄较大，有一种或多种潜在的心血管疾病。目的：确定伐地那非新口服分散片（ODT）制剂治疗ED的疗效和安全性，以及年龄或基础疾病的存在是否会影响治疗效果。方法：这是对两项III期，双盲，多中心，随机，平行组，安慰剂对照研究的数据的综合分析，该研究比较了一般ED患者中10 mg按需伐地那非ODT与安慰剂的比较，分层，以使约50％的患者年龄≥65岁。按年龄（<6 5比> / = 65岁）和是否存在糖尿病，血脂异常或高血压来报告结果。主要观察指标：主要测量指标是国际勃起功能指数（IIEF-EF）的勃起功能域以及性交特征档案2（SEP2）和3（SEP3）。结果：在随机分配的701名男性（51％≥65岁）中，有686名被纳入了意向性治疗人群（安慰剂，n = 334;伐地那非ODT，n = 352）。无论年龄，基线ED严重程度或基础状况如何，凡瑞那非ODT的所有主要疗效指标均显着优于安慰剂（凡瑞那非与安慰剂的P <0.0001，每个终点均如此）。老年患者和患有基础疾病的男性的IIEF-EF评分和SEP2 / 3成功率与年轻患者或无基础疾病的男性的IIEF-EF得分和SEP2 / 3成功率无显着差异。不良事件（AE）的严重程度主要为轻度至中度，与伐地那非组相比，发生率较高。伐地那非组中最常报告的药物相关不良事件为头痛，潮红，鼻充血，头晕和消化不良，与已知的5型磷酸二酯酶抑制剂的安全性相符。结论：无论年龄，基线ED严重程度或基础状况如何，Vardenafil ODT均可显着改善患有ED的男性的勃起功能。

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