Time to Onset of Action of Vardenafil: A Retrospective Analysis of the Pivotal Trials for the Orodispersible and Film-Coated Tablet Formulations
Time to Onset of Action of Vardenafil: A Retrospective Analysis of the Pivotal Trials for the Orodispersible and Film-Coated Tablet Formulations
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DOI：
10.1111/j.1743-6109.2011.02462.x
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发表时间：
2011-10-01
影响因子：
3.5
通讯作者：
Beneke, Manfred
中科院分区：
文献类型：
--
作者：
Debruyne, Frans M. J.;Gittelman, Marc;Beneke, Manfred
导论.患者和医生认为快速起效是口服药物治疗勃起功能障碍的一个重要属性。研究一种新的伐地那非口腔分散片（ODT）制剂的起效时间。对两项10 mg伐地那非ODT的12周、双盲、多中心、随机、平行组、安慰剂对照III期试验的数据进行了事后综合分析。伐地那非薄膜包衣片的数据来自4项双盲、多中心、随机、平行组、固定剂量、安慰剂对照III期试验第12周的回顾性综合分析。确定给药和开始性活动（有性交意图）之间的时间间隔（以15分钟、30分钟和60分钟为增量，直至研究药物摄入后>= 6小时）。计算每个时间间隔的性交尝试总数和性接触概况问题3（SEP 3）成功率。给药后15分钟内，每例患者的平均SEP 3成功率为62.5%（伐地那非ODT）vs. 29.4%（安慰剂），相应的总体SEP 3成功率为59.8%和38.2%。在这段时间内，分别有5.3%和2.8%的性活动尝试是由服用伐地那非口服治疗（n = 89）或安慰剂（n = 62）的受试者发起的。在给药后16-30分钟，SEP 3成功率分别为65.3%和32.6%。伐地那非ODT组与安慰剂组分别为70.2%和51.0%（总体），相应的10.4%和8.7%的所有性活动尝试是由服用伐地那非ODT（n = 170）或安慰剂（n = 118）的受试者进行的10 mg和20 mg伐地那非薄膜包衣片在相应时间点的结果具有可比性。伐地那非ODT起效快，与伐地那非薄膜包衣片相当。在给药后30分钟内开始性活动的男性中，大多数性尝试导致成功性交。Debruyne FMJ、Gittelman M、Sperling H、Borner M和Beneke M。伐地那非起效时间：口服分散片和薄膜包衣片关键试验的回顾性分析。J Sex Med 2011;8：2912-2923.
Introduction. Patients and physicians consider a rapid onset of action to be an important attribute of oral pharmacotherapy for erectile dysfunction.Aim. To investigate the time to onset of action of a new orodispersible tablet (ODT) formulation of vardenafil.Methods. A post hoc integrated analysis was performed on data from two 12-week, double-blind, multicenter, randomized, parallel-group, placebo-controlled phase III trials of 10 mg vardenafil ODT. Data for the vardenafil film-coated tablet were generated from a retrospective integrated analysis at week 12 of four double-blind, multicenter, randomized, parallel-group, fixed-dose, placebo-controlled phase III trials. Time intervals (in 15-, 30-, and 60-minute increments, up to >= 6 hours after study medication intake) were determined for the period between dosing and start of sexual activity (with the intention of intercourse).Main Outcome Measures. The total number of sexual intercourse attempts and Sexual Encounter Profile question 3 (SEP3) success rates were calculated per time interval.Results. Within 15 minutes postdosing, mean per-patient SEP3 success rates were 62.5% (vardenafil ODT) vs. 29.4% (placebo), with corresponding overall SEP3 success rates of 59.8% and 38.2%. In this time interval, 5.3% vs. 2.8% of all sexual activity attempts were initiated by subjects taking vardenafil ODT (n = 89) or placebo (n = 62), respectively.At 16-30 minutes postdosing, SEP3 success rates were 65.3% and 32.6% (mean per-patient) and 70.2% and 51.0% (overall) for vardenafil ODT vs. placebo, respectively, with a corresponding 10.4% and 8.7% of all sexual activity attempts being made by subjects taking vardenafil ODT (n = 170) or placebo (n = 118).Comparable results were observed for vardenafil 10 and 20 mg film-coated tablet at corresponding time intervals.Conclusions. Vardenafil ODT shows a rapid onset of action comparable with that of vardenafil film-coated tablet. In those men who begin sexual activity within 30 minutes after dosing, the majority of sexual attempts lead to successful intercourse. Debruyne FMJ, Gittelman M, Sperling H, Borner M, and Beneke M. Time to onset of action of vardenafil: A retrospective analysis of the pivotal trials for the orodispersible and film-coated tablet formulations. J Sex Med 2011;8:2912-2923.