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

Sexual Medicine (Apr 2021)

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

Affiliations

Jing Peng, MD: Andrology Center, Department of Urology, Peking University First Hospital, Peking University, Beijing, China
Lin Yang, MD: Department of Urology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, China
Long Liu, MD: Department of Urology, North Theater General Hospital, Shenyang, China
Renyuan Zhou, MD: Department of Urology, Shanghai Jingan District Central Hospital, Shanghai, China
Jihong Liu, MD: Department of Urology, Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
Ningchen Li, MD: Department of Urology, Peking University Shougang Hospital, Beijing, China
Liming Li, MD: Department of Urology, General Hospital of Tianjin Medical University, Tianjin, China
Yongguang Jiang, MD: Department of Urology, Beijing Anzhen Hospital of Capital Medical University, Beijing, China
Yuqiang Liu, MD: Department of Urology, Second Hospital of Shandong University, Ji'nan, China
Zhaohui Zhu, MD: Department of Urology, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China
Xiaodong Zhang, MD: Department of Urology, Beijing Chaoyang Hospital of Capital Medical University, Beijing, China
Guowei Shi, MD: Department of Urology, Shanghai Fifth People's Hospital of Fudan University, Shanghai, China
Suyog Jain, MD: Medical Department, A Menarini Asia Pacific, Singapore
Emmanuele A. Jannini, MD: Chair of Endocrinology and Medical Sexology (ENDOSEX), Department of Systems Medicine, University of Rome Tor Vergata, Rome, Italy
Zhichao Zhang, MD: Andrology Center, Department of Urology, Peking University First Hospital, Peking University, Beijing, China; Corresponding Author: Zhichao Zhang, MD, Andrology Center, Peking University First Hospital, Peking University, Beijing 100034, China.Tel: 86-10-83222368; Fax: 86-10-83222822

Journal volume & issue: Vol. 9, no. 2
p. 100296

Abstract

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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.

Published in Sexual Medicine

ISSN: 2050-1161 (Online)
Publisher: Oxford University Press
Country of publisher: United Kingdom
LCC subjects: Medicine
Website: https://academic.oup.com/smoa

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