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

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)e18-e27
JournalSexual Medicine
Volume4
Issue number1
DOIs
Publication statusPublished - 2016 Mar 1

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dapoxetine
Premature Ejaculation
Patient Satisfaction
Ejaculation
Therapeutics
Safety
Serotonin Uptake Inhibitors

Keywords

  • Dapoxetine
  • PASSION Study
  • Premature Ejaculation

ASJC Scopus subject areas

  • Reproductive Medicine
  • Dermatology
  • Urology
  • Behavioral Neuroscience

Cite this

The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy : The PASSION Study. / McMahon, Chris; Lee, Sung Won; Kim, Sae Woong; Moon, Du Geon; Kongkanand, Apichat; Tantiwongse, Kavirach.

In: Sexual Medicine, Vol. 4, No. 1, 01.03.2016, p. e18-e27.

Research output: Contribution to journalArticle

McMahon, Chris ; Lee, Sung Won ; Kim, Sae Woong ; Moon, Du Geon ; Kongkanand, Apichat ; Tantiwongse, Kavirach. / The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy : The PASSION Study. In: Sexual Medicine. 2016 ; Vol. 4, No. 1. pp. e18-e27.
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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.",
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AU - Moon, Du Geon

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N2 - 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.

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