Burns Patrick R, Rosen Raymond C, Dunn Marian, Baygani Simin K, Perelman Michael A
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA.
J Sex Med. 2015 Mar;12(3):720-7. doi: 10.1111/jsm.12818. Epub 2015 Jan 23.
Treatment satisfaction of men receiving phosphodiesterase 5 inhibitors (PDE5) for erectile dysfunction (ED) and their partners is essential to successful long-term therapy.
This study aims to assess treatment satisfaction, in men with a partial response to on-demand (PRN) PDE5 and their female partners, following tadalafil 5 mg once daily or placebo.
The study was randomized, double-blind, parallel, and placebo-controlled in men primarily with mild to moderate ED. Treatment satisfaction was assessed following a 4-week maximum dose PRN lead-in, 4-week nondrug washout, and treatment through 12 weeks. Men were ≥18 years old with ED for ≥3 months and International Index of Erectile Function Erectile Function score of ≥17 and <26 at screening and <26 following PRN lead-in.
Treatment satisfaction was assessed using the Treatment Satisfaction Scale (TSS) for patients and partners. TSS domain scores range from 0 to 100, with higher values indicating greater satisfaction. Statistical comparisons were made using analysis of covariance.
Treatment satisfaction was significantly greater with tadalafil once daily vs. placebo across all TSS domains for both patients and their partners (all P < 0.001). For patients, mean scores for the TSS domains Confidence to Complete Sexual Activity and Satisfaction with Orgasm ranged from 53.7 to 57.8 after the PRN lead-in and 26.7 to 31.9 following the nondrug washout. Following randomized treatment, scores for tadalafil and placebo were 55.4 and 32.6, respectively, for Confidence to Complete Sexual Activity and 57.5 and 37.9, respectively, for Satisfaction with Orgasm. Results were comparable for other TSS domains and between men and their partners.
Treatment satisfaction was comparable for tadalafil 5 mg once daily and PRN PDE5 for both patients and female partners, suggesting that tadalafil once daily is a viable therapy option for men with ED who had a partial response to PRN PDE5 therapy.
接受磷酸二酯酶5抑制剂（PDE5）治疗勃起功能障碍（ED）的男性及其伴侣的治疗满意度对于长期治疗的成功至关重要。
本研究旨在评估按需（PRN）使用PDE5治疗反应欠佳的男性及其女性伴侣在服用他达拉非5毫克每日一次或安慰剂后的治疗满意度。
该研究为随机、双盲、平行且安慰剂对照试验，主要纳入轻度至中度ED男性。在进行为期4周的最大剂量PRN导入、4周的非药物洗脱期以及持续12周的治疗后，评估治疗满意度。男性年龄≥18岁，患有ED≥3个月，筛查时国际勃起功能指数（IIEF）勃起功能评分≥17且<26，PRN导入后<26。
使用患者及伴侣治疗满意度量表（TSS）评估治疗满意度。TSS领域评分范围为0至100，分数越高表明满意度越高。采用协方差分析进行统计学比较。
在所有TSS领域，患者及其伴侣每日一次服用他达拉非的治疗满意度均显著高于安慰剂（所有P<0.001）。对于患者，PRN导入后TSS领域“完成性活动的信心”和“性高潮满意度”的平均评分范围为53.7至57.8，非药物洗脱期后为26.7至31.9。随机治疗后，他达拉非组和安慰剂组在“完成性活动的信心”方面的评分分别为55.4和32.6，在“性高潮满意度”方面的评分分别为57.5和37.9。其他TSS领域以及男性与伴侣之间的结果具有可比性。
对于患者及其女性伴侣而言，每日一次服用5毫克他达拉非与PRN使用PDE5的治疗满意度相当，这表明每日一次服用他达拉非对于对PRN PDE5治疗反应欠佳的ED男性是一种可行的治疗选择。
