Division of Urology, Maimonides Medical Center, New York, NY 11219, USA.
J Sex Med. 2013 Mar;10(3):844-56. doi: 10.1111/j.1743-6109.2012.02898.x. Epub 2012 Oct 4.
Tadalafil is efficacious and well tolerated for erectile dysfunction (ED), but effects in men with "complete ED" are unclear.
To investigate effects of once-daily tadalafil in men with no successful intercourse attempts at baseline.
Through a post hoc, pooled-data analysis of four randomized, double-blind trials on the effects of tadalafil 2.5 or 5 mg (vs. placebo) in men with ED, we evaluated efficacy and safety in subjects with 0 "yes" responses to Sexual Encounter Profile question 3 (SEP3) during an initial 4-week treatment-free run-in period.
Changes from baseline in the SEP diary and the International Index of Erectile Function-erectile function (IIEF-EF) domain were subjected to analysis of covariance models.
Five hundred ninety-five subjects with no successful attempts at baseline were included in the analysis. The mean (± standard deviation) age was 58.2 ± 10.7 years; and most subjects had ED for ≥ 1 year (95.0%). ED was severe in 61.5% and moderate in 26.4%. Approximately 45% had diabetes mellitus or hypertension. After 12 weeks, the mean per-patient SEP3 percentage increased from 0% to 32.4% with tadalafil 2.5 mg and to 46.4% with tadalafil 5 mg (each P < 0.001 vs. placebo). Corresponding data for successful penetration (SEP2) were increases from 21.1% to 48.2% with tadalafil 2.5 mg and from 24.4% to 66.2% with 5 mg (each P < 0.001 vs. placebo). Mean IIEF-EF increased from 9.7 to 15.7 with tadalafil 2.5 mg and from 10.7 to 19.2 with 5 mg (each P < 0.001 vs. placebo). Tadalafil also significantly improved the intercourse-satisfaction and overall-satisfaction domains (vs. placebo). Both doses of tadalafil were generally well tolerated, with adverse event rates similar to placebo.
The posttreatment intercourse success rate was 32% and 46% for tadalafil 2.5 mg and 5 mg, respectively, in men with no successful intercourse attempts at baseline.
他达拉非对勃起功能障碍（ED）有效且耐受性良好，但对“完全 ED”男性的疗效尚不清楚。
研究每日一次他达拉非对基线时无成功性交尝试的男性的疗效。
通过对四项关于他达拉非 2.5 或 5mg（与安慰剂相比）治疗 ED 的随机、双盲试验的事后、汇总数据分析，我们评估了初始 4 周无治疗洗脱期内 SEP3 问题回答为 0“是”的受试者的疗效和安全性。
SE 日记和国际勃起功能指数-勃起功能（IIEF-EF）域的变化采用协方差模型进行分析。
共纳入 595 名基线时无成功尝试的受试者进行分析。平均（±标准差）年龄为 58.2±10.7 岁；大多数受试者 ED 持续时间≥1 年（95.0%）。ED 严重程度为 61.5%，中度为 26.4%。约 45%的受试者患有糖尿病或高血压。治疗 12 周后，他达拉非 2.5mg 组 SEP3 百分比从基线时的 0%增加到 32.4%，5mg 组增加到 46.4%（均 P＜0.001 与安慰剂相比）。相应的成功插入（SEP2）数据显示，他达拉非 2.5mg 组从 21.1%增加到 48.2%，5mg 组从 24.4%增加到 66.2%（均 P＜0.001 与安慰剂相比）。他达拉非 2.5mg 组 IIEF-EF 从 9.7 增加到 15.7，5mg 组从 10.7 增加到 19.2（均 P＜0.001 与安慰剂相比）。他达拉非还显著改善了性交满意度和总体满意度领域（与安慰剂相比）。两种剂量的他达拉非均具有良好的耐受性，不良事件发生率与安慰剂相似。
基线时无成功性交尝试的男性中，他达拉非 2.5mg 和 5mg 的治疗后性交成功率分别为 32%和 46%。
