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

6533b824fe1ef96bd12814ab

RESEARCH PRODUCT

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

Mirone V Davide Arcaniolo Rivas D Bull S Aquilina Jw Verze P Pause Study Team Berchart G Hass M Ludvik G Aalto J Hendolin N Lukkarinen O Multanen M Nurmenniemi V Lukkarinen O Multanen M Nurmenniemi V Piha J Aheimer C Alebrahim Dehkordy A Andreessen R Aust C Baer P Bath V Baumgrass H Beck C Beecken Wd Behre H Beitzinger M Belusa A Bermes Ur Berning T Bieringer La Roche D Blasko S Boehmer S Borchardt A Boerner T Brands F Braun Pm Braun R Breu D Briken P Brueske T Bueker R Buse A Carius A Christoph F Cuno M Dats E Degen N Denil J Dietrichs K Domnitz R Dorn B Dubiel J Eckert R Ehrenberg W Eichler S El Khadra S Engl T Esser O Faragallah Ea Farahmandi R Finke G Fleig P Fruehauf E Gerhardt U Girke Cg Glauche J Gleissner J Gnann R Gralla O Grandin A Grewe W Gronau E Gruber S Grunert S Guelbeyaz M Guelden H Haendel D Haefele J Haghighat M Hahne D Haschemi Schirazi R Hecker D Herzig J Hettmmer R Hitschfeld K Hofmann J Hohmuth H Hoelker D Huebner A Hudemann B Hung Wehmann D Huenninghaus K Hueter K Igde H Jaeger T Javadi P John G Ju M Kaisser G Kamann L Kastein A Kaup F Kellner T Kempe T Kempter F Kennerknecht M Kirschner P Koenig M Konert J Kowalik S Krieger Ju Kruppa Gl Kube U Kuehn F Kuefer R Kurt T Kwela M Laag R Langen L Lehmann J Linder C Loeber T Lock Uc Loebenau M Luberg Sievers G Luebbe R Lutz K Maier S Maletz C Mertins B Meschede E Meschi Mr Miersch Wd Misera A Muehlich S Mueller Hw Mueller D Muench Hc Nawka P Othman K Paiss T Peter K Peters T Petras T Petrischenko B Pfund A Plate H Ploss Hj Pohrt U Pooyeh S Potempa Aj Pusinelli Wd Rausch U Reinhardt F Rengel U Rietheimer W Rinnab L Rohrmann K Romahn E Romitan Baum R Roessler T Rudolph R Rueffer J Rug M Rueth J Ruettgers E Santiago Rb Schaefer A Schaefer T Schaetzle P Scheunpflug K Schlicht J Schmidt P Schneider J Schnitzler M Schonfelder R Schreier H Schroeder A Schulz Fm Schulze M Schumann M Seidler A Schroeder A Schulz Fm Schumann M Seidler A Seseke S Siebel Eggeling G Siebels M Sinner B Sippel F Soballa M Sommer F Spielhaupter A Steffen H Steinacker M Stiersdorfer A Stoehr C Sturm S Surrey Hw Swoboda A Szymula S Telle J Uththoff H Vierneisel C Vilmar W Wagner M Walhoefer F Warnack W Weiss J Weizert P Wicht A Wieland J Willgerodt J Wilski B Wilson E Wipfler G Wohn Hg Wolf J Zoehrlaut B Zuerner T Angeletti G Avolio A Baldassarre R Balercia G Balloni F Barba G Bartoletti R Basile Fasolo C Bassi Pf Beatrici V Bertozzi Ma Bocciardi Am Bondavalli C Bonini F Bonsanto M Branchi A Briganti A Calabrese M Calafiore R Calogero Ae Cantelmo P Caraceni E Carbone A Cardella A Carini M Carmignani L Carmignani G Carrino M Caviglia C Cecchi M Ceruti C Chiovato L Cicalese V Colpi G Corinti M Cormio L Cova G Cozzupoli P Ottavio G Damiano R De Ceglie G De Grande G De Lisa A Marco De Sio De Stefani S Dehò F Delsignore A Di Filippo A Di Lena S Di Trapani D Diambrini M Drei Gn Fabbri A Fasolis G Ferone D Ferrari G Foresta C Francavilla S Gadda F Galantini A Galì A Gentile V Giammusso B Giannubilo W Granata A Grasso M Iafrate M Ilacqua N Isidori A Italiano E Jallous Ha Jannini E La Pera G Laganà F Lauretti S Leonardi R Liguori G Loiero G Lombardi G Lombardo F Lusenti C Maffucci A Maggi M Maio G Mammana G Manieri C Marzotto Caotorta M Mastroeni F Mazzilli F Mazzone L Minervini M Mirone Vg Montorsi F Morelli G Morrone G Nicita G Nicola M Palmiotto F Paradiso M Paulis G Pavone C Pescatori Es Petterle V Piazza N Pittaluga P Piubello G Polito M Ponchietti R Porena M Rago R Risi O Roggia A Salzano L Sanseverino R Ferdinando Carlo Sasso Savoca G Scarano P Schips L Serao A Sforza A Sidari V Silvani M Sinisi A Sorrentino F Spera E Strada G Tenaglia R Terrone C Titta M Tracia A Turchi P Ughi G Vecchio D Veneziano Ia Vicini P Vita A Vitti P Volpi R Zago T Zenico T Zito Ar Apolinario M Carvalho Ap Corte Real J Matos Cabeca J Mendes Leal A Monteiro Pereira N Palma Dos Reis J Patricio A Patricio A Prisco R Rocha Mendes J Santos A Vieira R Abad Gairín C Abascal García Jm Adot Zurbano Jm ÁLvarez De La Red Pl Al Wattar W Antón Saiz C Aranda Doncel N Arrosagaray Pm Arteaga Serrano F Barberán Soriano J Bataller Perello V Beltrán Persiva J Benejam Gual J Blanco Díez A Blasco Casares Fj Blasco Villalonga M Blázquez Izquierdo J Boladeras Sabater J Borrás Jj Bouchi Bakrim Ar Bucar Terrades S Burgués Gasión Jp Busto Castañón L Caballero Jm Cabello Santamaría F Cabreja López E Carrasco Aznar Jc Casasola Chamorro J Castellanos González L Cimadevila García A Closas Capdevila M Concepción Masip T Conde C Conde Santos G Cortada I. Robert J Cos Calvet Jm Crespi Martínez F Cruz N De La Rosa Khermann M Delgado Martín Ja Devesa Mújica M Doganis Peppas C Domínguez Freire F Donderis Guastavino C Duarte Vázquez Jj El Khoury Yacob R Escobal Tamayo V Farré Martí Jm Fernández Fernández A Fernández Lozano A Fernández Viñas Ja Fiter Gómez L Fleitas Asencio E Frago Valls Sm Galiana ÁLvarez A García Bayo I García Contreras J García Cruz E García De Jalón Martín A García Giralda L García Marco Ma García Navas R García Reboll L Garrido Insúa S Giner Santamaría C Giner Santamaría C Gómez Berjón F Gómez Gil E Gómez Lanza E Gómez Pérez L Gómez Rodríguez A González Sala Jl González Sala Mj Gonzalvo Ybarra A Guerrero Martínez V Gutiérrez González Ma Gutierrez Mínguez E Hidalgo Arroyo J Hmeidan M Idígora I. Planas X Jara Rascón J Jiménez Verdejo J Lledó García E Lliteras Arañi M López Almansa M López Palacios Má López Tello J Lorenzo Gómez Mf Luque Gálvez P Luque López Aj Mallafré Sala Jm Martí Cebrián Jm Martín Clos J Martín Huescar A Martín Morales A Martín Rodríguez A Martínez Rodríguez R Martínez Salamanca Ji Mascarós Balaguer E Mejide Manresa R Molero Rodríguez F Molina Carranza A Moncada Iribarren I Montagud Moncho Jb Montesino Semper M Mosteiro Ponce Ja Mouaffak Tatari N Navarro Gil Jm Novás Castro S Ortiz Del Corral Ml Ortiz Gamiz A Osca García Jm Padilla León M Palomino García A Pascual Mateo C Peinado Ibarra F Pérez Mestre M Portillo Martín Ja Poyato Galán Jm Prats De Puig J Prieto Castro R Puigvert Martínez A Quintana De La Rosa Jl Ramada Benlloch Fj Reyes Martínez F Rigabert M Ríos Espuny Af Robles Iniesta A Rodrigo Aliaga M Rodríguez Alba Jl Rodríguez Bethencourt F Rodríguez Jiménez Fj Rodríguez Leal Da Rodríguez Rubio F Rodríguez Tolrá J Rodríguez Vallejo Jm Romero Otero J Roselló Barbará M Rubio Briones J Ruíz Moriana O Sampol Company J San Martín Blanco C Sánchez Encinas M Sánchez Sánchez F Sancho Serrano C Santandreu Puifros J Santisteban González M Santos Ascarza Tabares Jl Sanz Lahoz I Sapiña Ortola F Sarquella Geli J Segarra Tomás J Soler Fernández J Tato Rodríguez J Tesedo Cubedo J Traid Sender V Valbuena ÁLvarez R Valverde Rubio Jm Varela Salgado M Vargas Rugeles M Vilches Cocovi E Virto Bajo Fj Andius P Anker Hansen O Arver S Bosson P Brattberg A Grenabo L Hanning J Hassler L Paradis Aå Wang E.

subject

Adult Complementary Therapies Male medicine.medical_specialty Benzylamines Adolescent Nausea Urology Naphthalenes Dapoxetine Safety Cardiovascular events Syncope Syncope Cardiovascular events Young Adult Internal medicine Premature ejaculation medicine 80 and over 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 Humans Prospective Studies Premature Ejaculation Adverse effect Prospective cohort study Cardiovascular events; Safety; Dapoxetine Aged Cardiovascular events; Dapoxetine; Safety; Syncope; Urology Aged 80 and over Sertraline business.industry Settore MED/24 - UROLOGIA Incidence (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; Urology Middle Aged Dapoxetine Cardiovascular events; Dapoxetine; syncope; Safety Dapoxetine Anesthesia Serotonin Uptake Inhibitors Observational study medicine.symptom Safety business Selective Serotonin Reuptake Inhibitors medicine.drug Cardiovascular events Dapoxetine Safety Syncope

description

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). Interventions Treatment with dapoxetine or alternative care/nondapoxetine. Outcome measurements and statistical analysis Treatment-emergent adverse events (TEAEs) and concomitant therapy use during the 12-wk observational and the postobservational period were reported. Results and limitations The mean age for all patients was 40.5 yr. In group A, 93.0% of the patients were initially prescribed dapoxetine 30mg. Treatment options for group B patients included clomipramine, paroxetine, fluoxetine, sertraline, topical drugs, condoms, and behavioral counseling. Both treatment regimens were well tolerated. TEAEs were reported by 12.0% and 8.9% of group A and group B, respectively, with the highest incidence observed in patients aged >65 yr for group A (21.4%) and 30–39 yr (9.8%) for group B. The most commonly reported TEAEs were nausea, headache, and vertigo, with a higher incidence in group A (3.1%, 2.6%, and 1.0%, respectively) than in group B (oral drugs: 2.3%, 1.3%, and 0.9%, respectively). There were no cases of syncope in group A and one case in group B. A major limitation is that this was a nonrandomized, open-label, short-term study lacking efficacy data. Conclusions The results of this postmarketing observational study demonstrated that dapoxetine for treatment of PE has a good safety profile and low prevalence of TEAEs. Syncope and major cardiovascular adverse events were not reported. The high level of adherence by healthcare providers to the contraindications, special warnings, and precautions for dapoxetine minimizes the risk for its use in routine clinical practice. The current risk minimization measures for its identified and potential risks are effective.

year	journal	country	edition	language
2014-01-01

10.1016/j.eururo.2013.08.018 http://hdl.handle.net/2318/1665710