The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy: The PASSION Study
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...
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| Format: | Article |
| Language: | English |
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Oxford University Press
2016-03-01
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| Series: | Sexual Medicine |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2050116116000088 |
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| author | Chris McMahon, MBBS, FAChSHM Sung Won Lee, MD, PhD Sae Woong Kim, MD, PhD Du Geon Moon, MD Apichat Kongkanand, MD Kavirach Tantiwongse, MD |
| author_facet | Chris McMahon, MBBS, FAChSHM Sung Won Lee, MD, PhD Sae Woong Kim, MD, PhD Du Geon Moon, MD Apichat Kongkanand, MD Kavirach Tantiwongse, MD |
| author_sort | Chris McMahon, MBBS, FAChSHM |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T08:16:37Z |
| format | Article |
| id | doaj.art-32db001ea1d84aabbbf6a65f497eb8bb |
| institution | Directory Open Access Journal |
| issn | 2050-1161 |
| language | English |
| last_indexed | 2024-03-12T08:16:37Z |
| publishDate | 2016-03-01 |
| publisher | Oxford University Press |
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| series | Sexual Medicine |
| spelling | doaj.art-32db001ea1d84aabbbf6a65f497eb8bb2023-09-02T18:45:49ZengOxford University PressSexual Medicine2050-11612016-03-0141e18e2710.1016/j.esxm.2015.12.006The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy: The PASSION StudyChris McMahon, MBBS, FAChSHM0Sung Won Lee, MD, PhD1Sae Woong Kim, MD, PhD2Du Geon Moon, MD3Apichat Kongkanand, MD4Kavirach Tantiwongse, MD5Australian Centre for Sexual Health, St. Leonards, NSW, AustraliaDepartment of Urology, Sungkyunkwan University School of Medicine, Seoul, Republic of KoreaDepartment of Urology, Catholic University, Seoul St. Mary's Hospital, Seoul, Republic of KoreaDepartment of Urology, Korea University College of Medicine, Seoul, Republic of KoreaDepartment of Urology, Bumrungrad International Hospital, Wattana, Bangkok, ThailandDepartment of Urology, Bumrungrad International Hospital, Wattana, Bangkok, ThailandIntroduction: 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.http://www.sciencedirect.com/science/article/pii/S2050116116000088DapoxetinePremature EjaculationPASSION Study |
| spellingShingle | Chris McMahon, MBBS, FAChSHM Sung Won Lee, MD, PhD Sae Woong Kim, MD, PhD Du Geon Moon, MD Apichat Kongkanand, MD Kavirach Tantiwongse, MD The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy: The PASSION Study Sexual Medicine Dapoxetine Premature Ejaculation PASSION Study |
| title | The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy: The PASSION Study |
| title_full | The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy: The PASSION Study |
| title_fullStr | The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy: The PASSION Study |
| title_full_unstemmed | The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy: The PASSION Study |
| title_short | The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy: The PASSION Study |
| title_sort | asia pacific flexible dose study of dapoxetine and patient satisfaction in premature ejaculation therapy the passion study |
| topic | Dapoxetine Premature Ejaculation PASSION Study |
| url | http://www.sciencedirect.com/science/article/pii/S2050116116000088 |
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