Evaluation of the long-term safety and effectiveness of tadalafil once daily in Chinese men with erectile dysfunction: interim results of a multicenter,randomized, open-label trial

• 来源期刊: 亚洲男性学杂志（英文版）
• 年，卷（期）: 2018,（6）
• 页码范围: 587-592
• 页数: 6页
• 语种: 英文

摘要

Once-daily tadalafil administration has been well established;however,studies about tadalafil once-daily treatment in the Chinese population are lacking.In this phase 4,postmarketing study,we ascertained the long-term safety and effectiveness of tadalafil 2.5 mg and 5.0 mg once daily in Chinese men with erectile dysfunction (n =635).The primary endpoint of the study was safety at 12 months as assessed by the proportion of patients experiencing at least one treatment-emergent adverse event (serious or nonserious).The secondary endpoints included safety and effectiveness,measured by the International Index of Erectile Function-Erectile Function (IIEF-EF) domain scores.Similar adverse events to the known safety profile of tadalafil,such as nasopharyngitis,upper respiratory tract infection,headache,and dizziness,were detected.No new cardiovascular safety concerns were observed.After 3 months of treatment,significant increases in IIEF-EF domain scores were detected for both 2.5-mg (least squares [LS] mean change:6.3;95％ confidence interval [Cl]:5.4-7.1;P ＜ 0.001) and 5.0-mg (LS mean change:7.4;95％ Cl:6.8-7.9;P ＜ 0.001) tadalafil doses,and significance was maintained up to 12 months.In addition,approximately 40％ of patients regained normal erectile function (IIEF-EF ＞26) following 1 year of tadalafil once-daily treatment.The findings in this study provide evidence for the extended effectiveness and tolerability of tadalafil,demonstrating no new safety concerns,in a Chinese population and make once-daily tadalafil administration a viable option for improving sexual performance and satisfaction in Chinese men with erectile dysfunction.