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

一次每日的 tadalafil 管理很好被建立了；然而，关于在中国人口的一次每日的治疗正在缺乏的 tadalafil 学习。在这分阶段执行 4， postmarketing 学习，我们查明了 tadalafil 的长期的安全和有效性 2.5 mg 和在有可勃起的机能障碍的中国人从前每日的 5.0 mg (n = 635 ) 。学习的主要端点是在由经历至少一个处理突现的不利事件的病人的比例估计了的 12 个月的安全(严肃或 nonserious ) 。第二等的端点包括了安全和有效性，由可勃起的功能可勃起的功能(IIEF-EF ) 领域分数的国际索引测量了。到 tadalafil 的已知的安全侧面的类似的不利事件例如鼻咽炎，上面的呼吸的道感染，头疼，和头昏，被检测。没有新心血管的安全担心被观察。在 3 月治疗以后， IIEF-EF 领域分数的重要增加为两 2.5-mg 被检测(最少的广场[LS ] 吝啬的变化：6.3；95% 信心间隔[CI ] ：5.4-7.1；P < 0.001 ) 并且 5.0-mg (LS 吝啬的变化：7.4；95% CI：6.8-7.9；P < 0.001 ) tadalafil 剂量，和意义被维持直到 12 个月。另外，约 40% 病人重获跟随 1 年 tadalafil 的正常可勃起的功能(IIEF-EF 26 ) 一次每日的治疗。在这研究的调查结果为 tadalafil 的扩大有效性和 tolerability 提供证据，示威不新的安全担心，在一张中国人口并且为与可勃起的机能障碍在中国人改进性性能和满足使一次每日的 tadalafil 管理成为一种可行选择。

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 [CI]： 5.4-7.1; P 〈 0.001） and 5.0-mg （LS mean change： 7.4; 95% CI： 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.