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Abstract

Volume 20, Issue 6 (November 2018) 20, 587–592; 10.4103/aja.aja_47_18

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

Hui Jiang1, Lian-Ming Zhao1, Hao-Cheng Lin1, Su Yan2, Ji-Hong Liu3, Zhao-Hui Zhu4, Jin-Dan Luo5, Yu-Tian Dai6, Fu-Biao Li7, Ying Lou8, Zhi-Chao Zhang9

1 Department of Urology, Peking University Third Hospital, Beijing 100191, China
2 Department of Urology, Peking Union Medical College Hospital, Beijing 100730, China
3 Department of Urology, Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China
4 Department of Urology, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China
5 Department of Urology, The First Affiliated Hospital, Zhejiang University, Hangzhou 310003, China
6 Department of Andrology, Nanjing Drum Tower Hospital, Nanjing 210008, China
7 Department of Andrology, The First Hospital of Jilin University, Changchun 130021, China
8 Lilly Suzhou Pharmaceutical Co., Ltd Shanghai Branch, Shanghai 200041, China
9 Peking University First Hospital, Institute of Urology, Peking University, Beijing 100034, China

Correspondence: Dr. ZC Zhang (zhangzhichao@bjmu.edu.cn) or Dr. HC Lin (haochenglin292@163.com)

Date of Submission 13-Feb-2018 Date of Acceptance 07-May-2018 Date of Web Publication 10-Jul-2018

Abstract

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.

Keywords: erectile dysfunction; long-term safety; once-daily dosing; tadalafil

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