The long-term safety and effectiveness of once-daily tadalafil is crucial, but limited data are available in Chinese patients with erectile dysfunction (ED). In this post-marketing, multicenter, randomized, open-label trial with 2-year follow-up, 635 ED cases were randomized to receive daily oral tadalafil 2. 5 mg or 5 mg for 3 months, of whom 580 continued once-daily tadalafil 5 mg for 21 months. Treatment-emergent adverse events in the 12-month and 24-month period were similar, with the most common being viral upper respiratory tract infection, upper respiratory tract infection, and headache. Significant improvement from baseline in the International Index of Erectile Function-Erectile Function (IIEF-EF) score was detected at month 12 (least squares mean [LSM] change: 7.9, 95% confidence interval [CI]: 7.5-8.4, P < 0.001) and was maintained to month 24 (LSM change: 8.6, 95% CI: 8.1-9.0, P < 0.001). The proportions of patients regaining normal erectile function (IIEF-EF score ≥26) were 43.7% and 48.0% at months 12 and 24, respectively. Global Assessment Questionnaire results showed improved erection function in 97.5% of patients and improved ability to engage in sexual activity in 95.9% of patients at month 12; these values were 96.1% and 95.0% at month 24, respectively. The quality of sexual life score based on the Sexual Life Quality Questionnaire (SLQQ) was increased by 52.2% at month 12 and by 55.3% at month 24 (both P < 0.001). The treatment satisfaction score determined by SLQQ (mean ± standard deviation) was 62.4 ± 21.0 at month 12 versus 65.9 ± 20.2 at month 24. Two-year daily application of tadalafil 5 mg in Chinese men with ED showed a favorable safety profile and durable improvement in sexual performance and satisfaction.
Asian journal of andrology. 2024 Jan 26 [Epub ahead of print]
Hui Jiang, Lian-Ming Zhao, Su Yan, Ji-Hong Liu, Zhao-Hui Zhu, Jin-Dan Luo, Yu-Tian Dai, Fu-Biao Li, Hao-Cheng Lin, Zhi-Chao Zhang
Department of Urology, Peking University First Hospital, Beijing 100000, China., Department of Urology, Peking University Third Hospital, Beijing 100191, China., Department of Urology, Peking Union Medical College Hospital, Beijing 100730, China., Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430030, China., Department of Urology, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China., Department of Urology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, China., Department of Andrology, Nanjing Drum Tower Hospital, Nanjing 210008, China., Department of Andrology, The First Hospital of Jilin University, Changchun 130021, China., Andrology Center, Department of Urology, Peking University First Hospital, Beijing 100034, China.