Vardenafil improves erectile function in men with erectile dysfunction irrespective of disease severity and disease classification.
Vardenafil improves erectile function in men with erectile dysfunction irrespective of disease severity and disease classification.
复制标题
伐地那非可改善患有勃起功能障碍的男性的勃起功能，无论疾病严重程度和疾病分类如何。
DOI：
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发表时间：
2004
影响因子：
3.5
通讯作者：
F. Montorsi
中科院分区：
文献类型：
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作者：
C. Donatucci;I. Eardley;J. Buvat;M. Gittelman;P. Kell;T. Segerson;M. Homering;F. Montorsi
背景
伐地那非（艾力达）是一种有效的选择性磷酸二酯酶5（PDE 5）抑制剂，用于治疗勃起功能障碍（艾德）。这项回顾性亚组分析评估了伐地那非治疗不同基线严重程度和疾病分类的男性艾德的有效性。
方法
回顾性分析了两项关键、随机、双盲、安慰剂对照临床试验的数据，这些试验招募了来自普通艾德人群的男性，这些男性在12周治疗期间接受安慰剂或伐地那非5 mg、10 mg或20 mg，并根据研究者确定的心因性、器质性和混合性ED疾病分类进行分层。艾德。疗效终点包括国际勃起功能指数（IIEF）-勃起功能（EF）领域评分、每例患者对阴茎插入问题[性接触特征（SEP-2）]和勃起维持（SEP-3）的日记应答率以及对总体评估问题（GAQ）的阳性应答率。
结果
列出了来自1，385名至少接受一剂研究药物并具有基线前和基线后有效性测量结果的男性（意向治疗人群）的数据。在基线时，37-41%的患者患有重度艾德，30-34%中度，22%轻度至中度和6-8%轻度ED。在基线时，46-51%的患者被认为具有艾德的器质性原因，13-16%的心因性艾德和36-38%的混合分类的ED。对于所有分类和轻度至中度至重度艾德，与安慰剂组相比，服用10或20 mg伐地那非的男性在IIEF-EF评分、SEP-2和SEP-3问题的日记应答率和GAQ方面表现出统计学和临床显著性改善（P < 0.001）。最常见的治疗后出现的不良事件是头痛、潮红、鼻炎、消化不良，并且与剂量相关，大多数是轻度至中度的强度，并且与类别一致。
结论
伐地那非可改善艾德男性患者的EF，而与治疗者确定的分类和基线艾德严重程度无关。
BACKGROUND
Vardenafil (Levitra) is a potent and selective phosphodiesterase 5 (PDE5) inhibitor used in the management of erectile dysfunction (ED). This retrospective subgroup analysis assessed the effectiveness of vardenafil treatment in men with ED of different baseline severity and disease classification.
METHODS
Data from two pivotal, randomized, double-blind, placebo-controlled clinical trials enrolling men from the general ED population who received placebo or vardenafil 5 mg, 10 mg, or 20 mg during a 12-week treatment period were retrospectively analysed, stratifying by psychogenic, organic, and mixed ED disease classification as determined by the investigator. Efficacy endpoints included the International Index of Erectile Function (IIEF)-Erectile Function (EF) domain score, per-patient diary response rates to questions on penile insertion [Sexual Encounter Profile (SEP-2)] and maintenance of erection (SEP-3) and rates of positive response to the Global Assessment Question (GAQ).
RESULTS
Data from 1,385 men who received at least one dose of study medication and had pre- and post-baseline measures of efficacy available (intent-to-treat population) are presented. At baseline 37-41% of patients had severe ED, 30-34% moderate, 22% mild-to-moderate and 6-8% mild ED. At baseline, 46-51% of patients were considered to have an organic cause for ED, 13-16% psychogenic ED, and 36-38% mixed classification of ED. For all classifications and for mild-to-moderate to severe ED, men treated with 10 or 20 mg of vardenafil showed statistically and clinically significant improvements (P < 0.001) in IIEF-EF scores, diary response rates to the SEP-2 and SEP-3 questions, and GAQ as compared with those given placebo. The greatest improvements relative to placebo were noted in patients with more severe ED. The most common treatment-emergent adverse events were headache, flushing, rhinitis, dyspepsia, and were dose-related, mostly mild to moderate in intensity and consistent with the class.
CONCLUSIONS
Vardenafil improves EF in men with ED irrespective of investigator-determined classification and baseline ED severity.