Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study

Jing Peng; Lin Yang; Long Liu; Renyuan Zhou; Jihong Liu; Ningchen Li; Liming Li; Yongguang Jiang; Yuqiang Liu; Zhaohui Zhu; Xiaodong Zhang; Guowei Shi; Suyog Jain; Emmanuele A Jannini; Zhichao Zhang

doi:10.1016/j.esxm.2020.100296

Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study

Sex Med. 2021 Apr;9(2):100296. doi: 10.1016/j.esxm.2020.100296. Epub 2021 Jan 30.

Authors

Jing Peng¹, Lin Yang², Long Liu³, Renyuan Zhou⁴, Jihong Liu⁵, Ningchen Li⁶, Liming Li⁷, Yongguang Jiang⁸, Yuqiang Liu⁹, Zhaohui Zhu¹⁰, Xiaodong Zhang¹¹, Guowei Shi¹², Suyog Jain¹³, Emmanuele A Jannini¹⁴, Zhichao Zhang¹⁵

Affiliations

¹ Andrology Center, Department of Urology, Peking University First Hospital, Peking University, Beijing, China.
² Department of Urology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China.
³ Department of Urology, North Theater General Hospital, Shenyang, China.
⁴ Department of Urology, Shanghai Jingan District Central Hospital, Shanghai, China.
⁵ Department of Urology, Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
⁶ Department of Urology, Peking University Shougang Hospital, Beijing, China.
⁷ Department of Urology, General Hospital of Tianjin Medical University, Tianjin, China.
⁸ Department of Urology, Beijing Anzhen Hospital of Capital Medical University, Beijing, China.
⁹ Department of Urology, Second Hospital of Shandong University, Ji'nan, China.
¹⁰ Department of Urology, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.
¹¹ Department of Urology, Beijing Chaoyang Hospital of Capital Medical University, Beijing, China.
¹² Department of Urology, Shanghai Fifth People's Hospital of Fudan University, Shanghai, China.
¹³ Medical Department, A Menarini Asia Pacific, Singapore.
¹⁴ Chair of Endocrinology and Medical Sexology (ENDOSEX), Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy.
¹⁵ Andrology Center, Department of Urology, Peking University First Hospital, Peking University, Beijing, China. Electronic address: zhangzhichao@bjmu.edu.cn.

Abstract

Introduction: Dapoxetine on demand has been approved for premature ejaculation (PE) management in China; however, studies on the efficacy and safety of this treatment in the Chinese population are scarce.

Aim: The aim of this study was to evaluate the safety and effectiveness of dapoxetine 30 mg and 60 mg on demand in Chinese men with PE.

Methods: Phase IV real-world study on 1,252 patients with PE. If men reported no response to dapoxetine 30 mg after 4 weeks treatment, dapoxetine has been uptitrated at 60 mg for 4 weeks more.

Main outcome measure: Self-reported data were collected for demographics, general and sexual health characteristics, PE severity, and treatment safety and effectiveness, as measured by the PE profile questionnaire.

Results: Adverse events (AEs), such as nausea, thirst, headache, and dizziness, similarly to previous literature, were detected. The treatment-emergent AEs rate was higher in the patients treated with 30 and 60 mg (n = 192) compared with those treated with the dapoxetine 30 mg only (n = 1060) (34.4% vs 15.8%, respectively). No new safety concerns were observed. The overall effectiveness rates were 88.2% in subjects using 30 mg of dapoxetine, whereas a rescue from the previous failure was in 55.7% in the patients who received 60 mg after the initial 30 mg. Overall, 83.2% responded to dapoxetine at dosages equal to or lower than 60 mg.

Conclusion: The results in this study demonstrated in a large Chinese population that on-demand dapoxetine is a safe and effective symptomatic treatment in patients with PE. J Peng, L Yang, L Liu, et al. Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study. Sex Med 2021;9:100296.

Keywords: Dapoxetine; Effectiveness; Premature ejaculation; Safety; Sexual dysfunction; Treatment.