Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study
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...
Main Authors: | , , , , , , , , , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Elsevier
2021-04-01
|
Series: | Sexual Medicine |
Subjects: | |
Online Access: | http://www.sciencedirect.com/science/article/pii/S2050116120301835 |
id |
doaj-97b135e75c454052b5ead674441b4ee6 |
---|---|
record_format |
Article |
spelling |
doaj-97b135e75c454052b5ead674441b4ee62021-04-12T04:22:34ZengElsevierSexual Medicine2050-11612021-04-0192100296Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV StudyJing Peng, MD0Lin Yang, MD1Long Liu, MD2Renyuan Zhou, MD3Jihong Liu, MD4Ningchen Li, MD5Liming Li, MD6Yongguang Jiang, MD7Yuqiang Liu, MD8Zhaohui Zhu, MD9Xiaodong Zhang, MD10Guowei Shi, MD11Suyog Jain, MD12Emmanuele A. Jannini, MD13Zhichao Zhang, MD14Andrology Center, Department of Urology, Peking University First Hospital, Peking University, Beijing, ChinaDepartment of Urology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, ChinaDepartment of Urology, North Theater General Hospital, Shenyang, ChinaDepartment of Urology, Shanghai Jingan District Central Hospital, Shanghai, ChinaDepartment of Urology, Tongji Hospital Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaDepartment of Urology, Peking University Shougang Hospital, Beijing, ChinaDepartment of Urology, General Hospital of Tianjin Medical University, Tianjin, ChinaDepartment of Urology, Beijing Anzhen Hospital of Capital Medical University, Beijing, ChinaDepartment of Urology, Second Hospital of Shandong University, Ji'nan, ChinaDepartment of Urology, Union Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, ChinaDepartment of Urology, Beijing Chaoyang Hospital of Capital Medical University, Beijing, ChinaDepartment of Urology, Shanghai Fifth People's Hospital of Fudan University, Shanghai, ChinaMedical Department, A Menarini Asia Pacific, SingaporeChair of Endocrinology and Medical Sexology (ENDOSEX), Department of Systems Medicine, University of Rome Tor Vergata, Rome, ItalyAndrology 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: 86-10-83222822Introduction: 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.http://www.sciencedirect.com/science/article/pii/S2050116120301835Premature ejaculationDapoxetineTreatmentEffectivenessSafetySexual dysfunction |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
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 |
spellingShingle |
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 Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study Sexual Medicine Premature ejaculation Dapoxetine Treatment Effectiveness Safety Sexual dysfunction |
author_facet |
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 |
author_sort |
Jing Peng, MD |
title |
Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study |
title_short |
Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study |
title_full |
Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study |
title_fullStr |
Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study |
title_full_unstemmed |
Safety and Effectiveness of Dapoxetine On Demand in Chinese Men With Premature Ejaculation: Results of a Multicenter, Prospective, Open-Label Phase IV Study |
title_sort |
safety and effectiveness of dapoxetine on demand in chinese men with premature ejaculation: results of a multicenter, prospective, open-label phase iv study |
publisher |
Elsevier |
series |
Sexual Medicine |
issn |
2050-1161 |
publishDate |
2021-04-01 |
description |
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. |
topic |
Premature ejaculation Dapoxetine Treatment Effectiveness Safety Sexual dysfunction |
url |
http://www.sciencedirect.com/science/article/pii/S2050116120301835 |
work_keys_str_mv |
AT jingpengmd safetyandeffectivenessofdapoxetineondemandinchinesemenwithprematureejaculationresultsofamulticenterprospectiveopenlabelphaseivstudy AT linyangmd safetyandeffectivenessofdapoxetineondemandinchinesemenwithprematureejaculationresultsofamulticenterprospectiveopenlabelphaseivstudy AT longliumd safetyandeffectivenessofdapoxetineondemandinchinesemenwithprematureejaculationresultsofamulticenterprospectiveopenlabelphaseivstudy AT renyuanzhoumd safetyandeffectivenessofdapoxetineondemandinchinesemenwithprematureejaculationresultsofamulticenterprospectiveopenlabelphaseivstudy AT jihongliumd safetyandeffectivenessofdapoxetineondemandinchinesemenwithprematureejaculationresultsofamulticenterprospectiveopenlabelphaseivstudy AT ningchenlimd safetyandeffectivenessofdapoxetineondemandinchinesemenwithprematureejaculationresultsofamulticenterprospectiveopenlabelphaseivstudy AT liminglimd safetyandeffectivenessofdapoxetineondemandinchinesemenwithprematureejaculationresultsofamulticenterprospectiveopenlabelphaseivstudy AT yongguangjiangmd safetyandeffectivenessofdapoxetineondemandinchinesemenwithprematureejaculationresultsofamulticenterprospectiveopenlabelphaseivstudy AT yuqiangliumd safetyandeffectivenessofdapoxetineondemandinchinesemenwithprematureejaculationresultsofamulticenterprospectiveopenlabelphaseivstudy AT zhaohuizhumd safetyandeffectivenessofdapoxetineondemandinchinesemenwithprematureejaculationresultsofamulticenterprospectiveopenlabelphaseivstudy AT xiaodongzhangmd safetyandeffectivenessofdapoxetineondemandinchinesemenwithprematureejaculationresultsofamulticenterprospectiveopenlabelphaseivstudy AT guoweishimd safetyandeffectivenessofdapoxetineondemandinchinesemenwithprematureejaculationresultsofamulticenterprospectiveopenlabelphaseivstudy AT suyogjainmd safetyandeffectivenessofdapoxetineondemandinchinesemenwithprematureejaculationresultsofamulticenterprospectiveopenlabelphaseivstudy AT emmanueleajanninimd safetyandeffectivenessofdapoxetineondemandinchinesemenwithprematureejaculationresultsofamulticenterprospectiveopenlabelphaseivstudy AT zhichaozhangmd safetyandeffectivenessofdapoxetineondemandinchinesemenwithprematureejaculationresultsofamulticenterprospectiveopenlabelphaseivstudy |
_version_ |
1721530384961765376 |