0000000000558569

AUTHOR

Kempe T

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Results from a prospective observational study of men with premature ejaculation treated with dapoxetine or alternative care: The PAUSE study

2014

Abstract Background Dapoxetine hydrochloride is a selective serotonin reuptake inhibitor and the first drug approved for the on-demand treatment of premature ejaculation (PE). Its safety was established in a thorough clinical development program. Objective To characterize the safety profile of dapoxetine in PE treatment and to report the incidence, severity, and type of adverse events. Design, setting, and participants We conducted a 12-wk, open-label, observational study with a 4-wk, postobservational contact. A total of 10 028 patients were enrolled, with 6712 patients (67.6%) treated with dapoxetine 30–60mg (group A)and 3316 (32.4%) treated with alternative care/nondapoxetine (group B). …

AdultComplementary TherapiesMalemedicine.medical_specialtyBenzylaminesAdolescentNauseaUrologyNaphthalenesDapoxetine Safety Cardiovascular events SyncopeSyncopeCardiovascular eventsYoung AdultInternal medicinePremature ejaculationmedicine80 and overCardiovascular events; Dapoxetine; Safety; Syncope; Adolescent; Adult; Aged; Aged 80 and over; Benzylamines; Complementary Therapies; Humans; Male; Middle Aged; Naphthalenes; Premature Ejaculation; Prospective Studies; Serotonin Uptake Inhibitors; Young AdultHumansProspective StudiesPremature EjaculationAdverse effectProspective cohort studyCardiovascular events; Safety; DapoxetineAgedCardiovascular events; Dapoxetine; Safety; Syncope; UrologyAged 80 and overSertralinebusiness.industrySettore MED/24 - UROLOGIAIncidence (epidemiology)Cardiovascular events; Dapoxetine; Safety; Syncope; Adolescent; Adult; Aged; Aged 80 and over; Benzylamines; Complementary Therapies; Humans; Male; Middle Aged; Naphthalenes; Premature Ejaculation; Prospective Studies; Serotonin Uptake Inhibitors; Young Adult; UrologyMiddle AgedDapoxetineCardiovascular events; Dapoxetine; syncope; SafetyDapoxetineAnesthesiaSerotonin Uptake InhibitorsObservational studymedicine.symptomSafetybusinessSelective Serotonin Reuptake Inhibitorsmedicine.drugCardiovascular events Dapoxetine Safety Syncope
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