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      Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation: A 2-Year Prospective Observational Study

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          Abstract

          Introduction

          Although dapoxetine is the only oral pharmacologic agent approved for the treatment of premature ejaculation (PE) and is very effective, the discontinuation rate is high.

          Aim

          To assess the discontinuation rate of patients with PE and the reasons for discontinuation in real-world practice.

          Methods

          In total, 182 consecutive patients were enrolled. Type of PE, self-estimated intravaginal ejaculation latency time, and medical history were evaluated in all patients who also completed the erectile function domain of the International Index of Erectile Function (IIEF). Visits were scheduled 1, 3, 6, 12, and 24 months after initiation of therapy; treatment status and the reasons for discontinuation in those who did discontinue were checked. The relations of discontinuation rates were compared with various parameters and the time to discontinuation after treatment commencement.

          Results

          Of all patients, 9.9% continued treatment to 2 years. The cumulative discontinuation rates at 1, 3, 6, 12, and 24 months were 26.4%, 61.6%, 79.1%, 87.3%, and 90.1%, respectively. Moreover, 79.1% of all patients discontinued treatment within 6 months. After 12 months, the discontinuation rate decreased sharply. The reasons for discontinuation were cost (29.9%), disappointment that PE was not curable and that dapoxetine was required every time sexual intercourse was contemplated (25%), side effects (11.6%), perceived poor efficacy (9.8%), a search for other treatment options (5.5%), and unknown (18.3%). Patients with acquired PE (vs lifelong PE), with intravaginal ejaculation latency time longer than 2 minutes before treatment, on phosphodiesterase type 5 inhibitors, and with IIEF erectile function scores lower than 26 tended to discontinue early and thus exhibited high dropout rates.

          Conclusion

          The treatment discontinuation rate of dapoxetine was very high. The main reasons for discontinuation were the cost and disappointment that treatment was required every time adequate sexual function was required.

          Park HJ, Park NC, Kim TN, et al. Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation: A 2-Year Prospective Observational Study. Sex Med 2017;5:e99–e105.

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          An Update of the International Society of Sexual Medicine's Guidelines for the Diagnosis and Treatment of Premature Ejaculation (PE)

          Introduction In 2009, the International Society for Sexual Medicine (ISSM) convened a select panel of experts to develop an evidence-based set of guidelines for patients suffering from lifelong premature ejaculation (PE). That document reviewed definitions, etiology, impact on the patient and partner, assessment, and pharmacological, psychological, and combined treatments. It concluded by recognizing the continually evolving nature of clinical research and recommended a subsequent guideline review and revision every fourth year. Consistent with that recommendation, the ISSM organized a second multidisciplinary panel of experts in April 2013, which met for 2 days in Bangalore, India. This manuscript updates the previous guidelines and reports on the recommendations of the panel of experts. Aim The aim of this study was to develop clearly worded, practical, evidenced-based recommendations for the diagnosis and treatment of PE for family practice clinicians as well as sexual medicine experts. Method A comprehensive literature review was performed. Results This article contains the report of the second ISSM PE Guidelines Committee. It offers a new unified definition of PE and updates the previous treatment recommendations. Brief assessment procedures are delineated, and validated diagnostic and treatment questionnaires are reviewed. Finally, the best practices treatment recommendations are presented to guide clinicians, both familiar and unfamiliar with PE, in facilitating treatment of their patients. Conclusion Development of guidelines is an evolutionary process that continually reviews data and incorporates the best new research. We expect that ongoing research will lead to a more complete understanding of the pathophysiology as well as new efficacious and safe treatments for this sexual dysfunction. We again recommend that these guidelines be reevaluated and updated by the ISSM in 4 years. Althof SE, McMahon CG, Waldinger MD, Serefoglu EC, Shindel AW, Adaikan PG, Becher E, Dean J, Giuliano F, Hellstrom WJG, Giraldi A, Glina S, Incrocci L, Jannini E, McCabe M, Parish S, Rowland D, Segraves RT, Sharlip I, and Torres LO. An update of the International Society of Sexual Medicine's guidelines for the diagnosis and treatment of premature ejaculation (PE). Sex Med 2014;2:60–90.
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            Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials.

            No drugs are approved for treatment of premature ejaculation. Our aim was to determine the efficacy and tolerability of on-demand dapoxetine in patients with severe premature ejaculation. We determined the efficacy of dapoxetine in a prospectively predefined integrated analysis of two 12-week randomised, double-blind, placebo-controlled, phase III trials of identical design done independently, in parallel, at 121 sites in the USA. Men with moderate-to-severe premature ejaculation in stable, heterosexual relationships took placebo (n=870), 30 mg dapoxetine (874), or 60 mg dapoxetine (870) on-demand (as needed, 1-3 h before anticipated sexual activity). The primary endpoint was intravaginal ejaculatory latency time (IELT) measured by stopwatch. Safety and tolerability were assessed. All analyses were done on an intention-to-treat basis. The trials are registered at ClinicalTrials.gov, numbers NCT00211107 and NCT00211094. 672, 676, and 610 patients completed in the placebo, 30 mg dapoxetine, and 60 mg dapoxetine groups, respectively. Dapoxetine significantly prolonged IELT (p<0.0001, all doses vs placebo). Mean IELT at baseline was 0.90 (SD 0.47) minute, 0.92 (0.50) minute, and 0.91 (0.48) minute, and at study endpoint (week 12 or final visit) was 1.75 (2.21) minutes for placebo, 2.78 (3.48) minutes for 30 mg dapoxetine, and 3.32 (3.68) minutes for 60 mg dapoxetine. Both dapoxetine doses were effective on the first dose. Common adverse events (30 mg and 60 mg dapoxetine, respectively) were nausea (8.7%, 20.1%), diarrhoea (3.9%, 6.8%), headache (5.9%, 6.8%), and dizziness (3.0%, 6.2%). On-demand dapoxetine is an effective and generally well tolerated treatment for men with moderate-to-severe premature ejaculation.
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              Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials.

              Dapoxetine has been evaluated for the on-demand treatment of premature ejaculation (PE) in five phase 3 studies in various populations worldwide and has recently been approved in several countries. To present integrated efficacy and safety data from phase 3 trials of dapoxetine. Data were from five randomized, multicenter, double-blind, placebo-controlled studies conducted in over 25 countries. Men (N=6,081)≥18 years who met the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision criteria for PE; four studies required a baseline intravaginal ejaculatory latency time (IELT) of ≤2 minutes. Dapoxetine 30 and 60 mg on demand (prn; 1-3 hours before intercourse) were evaluated for either 12 or 24 weeks in four studies; one study evaluated dapoxetine 60 mg daily (qd; included in safety assessments only) or prn for 9 weeks. End points included stopwatch-measured IELT, Premature Ejaculation Profile (PEP) items, clinical global impression of change (CGIC) in PE, and adverse events (AEs). Average IELT (mean [standard deviation], geometric mean [standard error]) increased from baseline (across groups, 0.9 [0.49] minutes, 0.8 [1.01] minutes) to a significantly greater extent with dapoxetine 30 (3.1 [3.91] minutes, 2.0 [1.03] minutes) and 60 mg (3.6 [3.85] minutes, 2.3 [1.03] minutes) vs. placebo (1.9 [2.43] minutes, 1.3 [1.02] minutes; P<0.001 for all) at week 12 (geometric mean fold increase, 2.5, 3.0, and 1.6, respectively). All PEP items and CGIC improved significantly with both doses of dapoxetine vs. placebo (P<0.001 for all). The most common AEs included nausea, dizziness, and headache, and evaluation of validated instruments demonstrated no anxiety, akathisia, suicidality, or changes in mood with dapoxetine use and no discontinuation syndrome following abrupt withdrawal. In this diverse population, dapoxetine significantly improved all aspects of PE and was generally well tolerated. © 2010 International Society for Sexual Medicine.
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                Author and article information

                Contributors
                Journal
                Sex Med
                Sex Med
                Sexual Medicine
                Elsevier
                2050-1161
                05 April 2017
                June 2017
                05 April 2017
                : 5
                : 2
                : e99-e105
                Affiliations
                [1 ]Department of Urology and Medical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Busan, Korea
                [2 ]Department of Clinical Pharmacology and Therapeutics, Pusan National University Hospital, Busan, Korea
                Author notes
                [] Corresponding Author: Hyun Jun Park, Department of Urology, Pusan National University Hospital, 1-10, Ami-dong, Seo-gu Busan 602-739, Republic of KoreaDepartment of UrologyPusan National University Hospital1-10, Ami-dongSeo-gu Busan602-739Republic of Korea joon501@ 123456naver.com
                Article
                S2050-1161(17)30019-3
                10.1016/j.esxm.2017.02.003
                5440632
                28395997
                ca1e5a2c-dda7-4e0f-8bf2-4602862a6bc9
                © 2017 The Authors

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

                History
                : 14 January 2017
                : 28 February 2017
                Categories
                Original Research
                Ejaculation Disorders

                premature ejaculation,serotonin uptake inhibitors,compliance

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