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Durability of response following cessation of tadalafil taken once daily as treatment for erectile dysfunction.

机译:他达拉非停止后应答的耐久性,每天服用一次以治疗勃起功能障碍。

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INTRODUCTION: Research has focused on improvement of erectile function during treatment with phosphodiesterase type 5 (PDE5) inhibitors, but less is known about what occurs after treatment cessation. AIM: The aim of this retrospective analysis was to examine durability of response, defined as sustainability of erectogenic benefits following treatment cessation, in men with erectile dysfunction (ED) following long-term treatment with daily tadalafil. METHODS: The subjects (N=160) had participated in a 12-week double-blind trial followed by a one-year, open-label extension of tadalafil 5mg once daily. The extension was followed by a 4-week, treatment-free follow-up period. A total of 158 subjects completed International Index of Erectile Function-Erectile Function (IIEF-EF) domain score and were included in this analysis. MAIN OUTCOME MEASURES: The primary measures for this analysis were changes in ED severity category as captured by the IIEF-EF domain score. RESULTS: At the end of the 1-year open-label treatment period, a majority (86.1%, n=136) of subjects had either improved by at least one ED severity category (e.g., Severe to Moderate) (n=128), or maintained Normal erectile function (EF domain score >/=26) (n=8), compared to baseline. Following the 4-week, treatment-free period, 63 of those subjects (46.3% of the 136 subjects) had continued improvement of at least one ED severity category (n=61) or maintained scores in the Normal category (n=2) compared with baseline. Subjects who showed a sustained benefit of treatment were considered to have demonstrated a "durable response." Seventy-three subjects (53.7%) did not have a durable response following treatment cessation. A few patient characteristics were associated with durability of response. CONCLUSIONS: Of those men who demonstrated improved erectile function while taking tadalafil 5mg once daily for 1 year, 46.3% continued to show improvement compared with baseline following a 4-week treatment free period. Durability of response should be a focus of future research.
机译:简介:研究集中在用5型磷酸二酯酶(PDE5)抑制剂治疗期间改善勃起功能,但对停药后发生的情况知之甚少。目的:这项回顾性分析的目的是检查长期接受每日他达拉非治疗的勃起功能障碍(ED)男性的反应持久性,定义为停药后勃起益处的可持续性。方法:受试者(N = 160)参加了一项为期12周的双盲试验,随后每天一次对他达拉非5mg进行为期一年的开放标签扩展。延长之后是4周的无治疗随访期。共有158位受试者完成了国际勃起功能指数-勃起功能指数(IIEF-EF)领域评分,并纳入了该分析。主要观察指标:这项分析的主要指标是通过IIEF-EF域评分捕获的ED严重程度类别的变化。结果:在1年开放标签治疗期结束时,大多数(86.1%,n = 136)的受试者至少改善了一种ED严重程度类别(例如,严重至中度)(n = 128) ,或与基线相比维持正常的勃起功能(EF域得分> / = 26)(n = 8)。在为期4周的免治疗期后,其中63名受试者(136名受试者中的46.3%)持续改善了至少一种ED严重程度类别(n = 61)或维持了正常类别(n = 2)的评分与基线相比。表现出持续治疗益处的受试者被认为表现出“持久的反应”。 73名受试者(53.7%)在停止治疗后没有持久反应。一些患者的特征与反应的持久性有关。结论:在每天服用他达拉非5mg连续1年同时表现出勃起功能改善的男性中,有46.3%的患者在4周的无治疗期后继续表现出与基线相比有所改善。反应的耐久性应成为未来研究的重点。

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