Department of Urology, University Vita-Salute San Raffaele, Via Olgettina, 58, 20132 Milan, Italy.
Division of Experimental Oncology/Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Via Olgettina, 58, 20132 Milan, Italy.
J Sex Med. 2024 Aug 1;21(8):671-675. doi: 10.1093/jsxmed/qdae064.
Daily (once a day [OaD]) tadalafil intake is a valuable option for men favoring spontaneous over scheduled sexual intercourse.
The study sought to assess the rate of and the clinical factors associated with spontaneous, medication-free erectile function (EF) recovery after discontinuation of tadalafil 5 mg OaD in a cohort of young men seeking first medical help for psychogenic erectile dysfunction (ED) as their primary complaint.
Data from 96 consecutive patients <50 years of age seeking first medical help for ED and prescribed tadalafil 5 mg OaD were analyzed. Patients completed the International Index of Erectile Function (IIEF) and underwent baseline penile color Doppler ultrasound. Follow-up involved clinical assessments or phone interviews. Spontaneous medication-free EF recovery was defined as IIEF EF domain score >22 after tadalafil discontinuation, prompting cessation of follow-up. Descriptive statistics compared tadalafil OaD responders and nonresponders. Cox regression hazard models explored the association between baseline characteristics and EF recovery risk post-drug discontinuation. Kaplan-Meier analyses estimated EF recovery probability over time.
The primary outcome was EF recovery after discontinuation of tadalafil 5 mg OaD.
Overall, median age was 39 (interquartile range [IQR], 32-45) years. Of all, 82 (85.4%) patients achieved EF recovery after tadalafil OaD discontinuation, while 14 (14.6%) patients were identified as nonresponders. Median tadalafil usage time (from beginning to discontinuation) was 3 (IQR, 2-11) months. The most common treatment-emergent adverse event was headache in 9 (9.4%) patients. Nonresponders were older (43 [IQR, 42-45] years vs 38 [IQR, 31-44] years; P = .03), had higher body mass index (25.5 [IQR, 23.4-29.9] kg/m2 vs 23.6 [IQR, 21.8-25.9] kg/m2; P = .04), and reported lower baseline IIEF EF domain scores (12 [IQR, 7-15] vs 15 [IQR, 10-22]; P = .02) than responders. Nonresponders and responders did not differ in terms of baseline ED severity, Charlson comorbidity index, smoking, alcohol consumption, regular physical exercise, and color Doppler ultrasound parameters. Upon Cox regression analysis, younger age (hazard ratio, 0.95; 95% confidence interval, 0.92-0.99; P = .01) was associated to EF recovery, after adjusting for baseline ED severity, body mass index, smoking, and Charlson comorbidity index ≥1. The Kaplan-Meier analysis displays the probability of EF recovery over time, indicating rates of 43%, 60%, and 72% at 3-, 6-, and 12-month follow-up intervals, respectively.
Tadalafil 5 mg OaD is an effective short-term treatment for psychogenic ED, allowing its discontinuation after achieving a normal medication-free EF.
The main limitations are the limited number of participants and the potential neglect of confounding factors.
Almost 1 out of 2 young men with primary psychogenic ED who were prescribed with tadalafil 5 mg OaD recovered spontaneous medication-free EF after 3 months of treatment. Overall, the younger the patient was, the higher the chance there was of spontaneous EF recovery after drug discontinuation.
对于喜欢自发性而非计划性交的男性来说，每日（每天一次）服用他达拉非是一种有价值的选择。
本研究旨在评估在因原发性心理性勃起功能障碍（ED）而首次寻求医疗帮助的年轻男性中，停止每日一次 5 毫克他达拉非治疗后，自发、无需药物的勃起功能（EF）恢复的比例，以及与自发、无需药物的 EF 恢复相关的临床因素。
分析了 96 例年龄小于 50 岁的连续患者，这些患者因原发性 ED 而首次寻求医疗帮助，并接受了他达拉非 5 毫克每日一次的治疗。患者完成了国际勃起功能指数（IIEF）问卷调查，并进行了基线阴茎彩色多普勒超声检查。随访包括临床评估或电话访谈。自发、无需药物的 EF 恢复定义为停用他达拉非后 IIEF EF 域评分>22，提示停止随访。描述性统计比较了他达拉非每日一次治疗的应答者和无应答者。Cox 回归风险模型探讨了基线特征与停药后 EF 恢复风险之间的关系。Kaplan-Meier 分析估计了随时间推移的 EF 恢复概率。
主要结局是停用他达拉非 5 毫克每日一次治疗后的 EF 恢复。
总体而言，中位年龄为 39 岁（四分位距 [IQR]，32-45 岁）。所有患者中有 82 例（85.4%）在停用他达拉非后实现了 EF 恢复，而 14 例（14.6%）患者被确定为无应答者。中位他达拉非使用时间（从开始到停药）为 3 个月（IQR，2-11 个月）。最常见的治疗后不良事件是 9 例（9.4%）患者出现头痛。无应答者年龄较大（43 [IQR，42-45] 岁 vs 38 [IQR，31-44] 岁；P=0.03），体重指数（BMI）较高（25.5 [IQR，23.4-29.9] kg/m2 vs 23.6 [IQR，21.8-25.9] kg/m2；P=0.04），基线 IIEF EF 域评分较低（12 [IQR，7-15] vs 15 [IQR，10-22]；P=0.02）。无应答者和应答者在基线 ED 严重程度、Charlson 合并症指数、吸烟、饮酒、规律体育锻炼和彩色多普勒超声参数方面没有差异。Cox 回归分析显示，在调整基线 ED 严重程度、BMI、吸烟和 Charlson 合并症指数≥1 后，年龄较小（风险比，0.95；95%置信区间，0.92-0.99；P=0.01）与 EF 恢复相关。Kaplan-Meier 分析显示了随时间推移的 EF 恢复概率，表明在 3、6 和 12 个月随访间隔时，EF 恢复率分别为 43%、60%和 72%。
他达拉非 5 毫克每日一次是治疗原发性 ED 的有效短期治疗方法，可在实现正常无需药物的 EF 后停药。
主要局限性是参与者人数有限，可能忽略了混杂因素。
在因原发性心理性 ED 而接受他达拉非 5 毫克每日一次治疗的年轻男性中，近 2 人中就有 1 人在治疗 3 个月后自发恢复无需药物的 EF。总体而言，患者年龄越小，停药后自发 EF 恢复的机会就越高。
