The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy: The PASSION Study
Autor: | Du Geon Moon, Apichat Kongkanand, Kavirach Tantiwongse, Sae Woong Kim, Chris McMahon, Sung Won Lee |
---|---|
Rok vydání: | 2016 |
Předmět: |
medicine.medical_specialty
Urology Endocrinology Diabetes and Metabolism media_common.quotation_subject Serotonin reuptake inhibitor 030232 urology & nephrology lcsh:Medicine Passion Dermatology 03 medical and health sciences Behavioral Neuroscience 0302 clinical medicine Endocrinology Asia pacific Patient satisfaction Premature ejaculation Medicine Premature Ejaculation Psychiatry PASSION Study Original Research media_common Ejaculation Disorder business.industry lcsh:R lcsh:Other systems of medicine Dapoxetine lcsh:RZ201-999 Data science Psychiatry and Mental health Reproductive Medicine 030220 oncology & carcinogenesis medicine.symptom business medicine.drug |
Zdroj: | Sexual Medicine, Vol 4, Iss 1, Pp e18-e27 (2016) Sexual Medicine |
ISSN: | 2050-1161 |
DOI: | 10.1016/j.esxm.2015.12.006 |
Popis: | 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. |
Databáze: | OpenAIRE |
Externí odkaz: |