The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy: The PASSION Study

Chris McMahon; Sung Won Lee; Sae Woong Kim; Du Geon Moon; Apichat Kongkanand; Kavirach Tantiwongse

doi:10.1016/j.esxm.2015.12.006

The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy: The PASSION Study

Sex Med. 2016 Mar;4(1):e18-27. doi: 10.1016/j.esxm.2015.12.006.

Authors

Chris McMahon¹, Sung Won Lee², Sae Woong Kim³, Du Geon Moon⁴, Apichat Kongkanand⁵, Kavirach Tantiwongse⁵

Affiliations

¹ Australian Centre for Sexual Health, St. Leonards, NSW, Australia. Electronic address: chrisgmcmahon@gmail.com.
² Department of Urology, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
³ Department of Urology, Catholic University, Seoul St. Mary's Hospital, Seoul, Republic of Korea.
⁴ Department of Urology, Korea University College of Medicine, Seoul, Republic of Korea.
⁵ Department of Urology, Bumrungrad International Hospital, Wattana, Bangkok, Thailand.

Abstract

Introduction: Dapoxetine is a short-acting selective serotonin reuptake inhibitor for treatment of premature ejaculation (PE).

Aim: To evaluate the efficacy and safety of dapoxetine 30 and 60 mg as needed in Asia-Pacific men with PE.

Methods: The study was a prospective, 12-week, open-label study to evaluate the efficacy and safety of flexible-dose dapoxetine in men with PE diagnosed by a Premature Ejaculation Diagnostic Tool score of at least 11, a self-estimated intravaginal ejaculation latency time (IELT) no longer than 2 minutes, and an International Index of Erectile Function erectile function domain score of at least 21.

Main outcome measures: Percentage of subjects reporting their PE as at least "slightly better" using the Clinical Global Impression of Change (CGIC) question.

Results: Two hundred eighteen of 285 randomized subjects completed the study. The mean subject age was 45.9 years and 57.7% were Korean. Dosages 1 (30 mg), 2 (30 → 60 mg), and 3 (30 → 60 → 30 mg) were used in 141, 124, and 13 subjects, respectively. At study end, a PE CGIC rating of at least "slightly better" was reported by 77.3%, 92.8%, and 100% of subjects for dosages 1, 2, and 3, respectively (P = .49). At study end, a CGIC rating of "slightly better" was reported by 85.2% and 85.3% of subjects with lifelong PE and acquired PE, respectively (P = .50). At study end, a CGIC rating of "slightly better" was reported by 84.1% and 86.4% of subjects with an estimated baseline IELT no longer than and at least ≤1 minute, respectively (P = .16). The incidence of a CGIC rating of at least "slightly better" was lower in subjects reporting an adverse event of moderate or severe severity and in subjects who increased to and maintained a dapoxetine dose of 60 mg and higher in subjects older than 50 years and in subjects with a baseline estimated IELT of at least 1 minute.

Conclusion: In this study, flexible dosing of dapoxetine (30 and 60 mg) appeared effective in the treatment of PE.

Keywords: Dapoxetine; PASSION Study; Premature Ejaculation.