Private Urological Practice, Hamburg, Germany.
J Sex Med. 2010 Oct;7(10):3487-94. doi: 10.1111/j.1743-6109.2010.01908.x.
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.
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.
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.
The primary measures for this analysis were changes in ED severity category as captured by the IIEF-EF domain score.
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.
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.
研究重点集中在使用磷酸二酯酶 5（PDE5）抑制剂治疗期间改善勃起功能，但对于治疗停止后会发生什么情况了解较少。
本回顾性分析的目的是检查勃起功能障碍（ED）患者长期接受每日他达拉非治疗后的反应持久性，即停止治疗后勃起益处的可持续性。
受试者（N=160）参加了一项为期 12 周的双盲试验，随后进行了为期一年的每日他达拉非 5mg 的开放标签扩展期。扩展期后进行了为期 4 周的无治疗随访期。共有 158 名受试者完成了国际勃起功能指数-勃起功能（IIEF-EF）域评分，并纳入本分析。
本分析的主要指标是 IIEF-EF 域评分所捕捉的 ED 严重程度类别的变化。
在为期 1 年的开放标签治疗期末，与基线相比，大多数（86.1%，n=136）受试者的 ED 严重程度至少改善了一个类别（例如，重度到中度）（n=128），或保持正常勃起功能（EF 域评分≥26）（n=8）。在 4 周的无治疗期后，与基线相比，其中 63 名受试者（136 名受试者中的 46.3%）继续改善至少一个 ED 严重程度类别（n=61）或保持正常类别评分（n=2）。表现出治疗持续获益的受试者被认为具有“持久反应”。停止治疗后，73 名受试者（53.7%）没有持久反应。一些患者特征与反应持久性相关。
在接受每日他达拉非 5mg 治疗 1 年后勃起功能改善的男性中，46.3%在 4 周无治疗期后与基线相比继续改善。反应持久性应成为未来研究的重点。
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