Efficacy and Safety of Dapoxetine for the Treatment of Premature Ejaculation: Integrated Analysis of Results from Five Phase 3 Trials
Identifieur interne : 000265 ( Istex/Corpus ); précédent : 000264; suivant : 000266Efficacy and Safety of Dapoxetine for the Treatment of Premature Ejaculation: Integrated Analysis of Results from Five Phase 3 Trials
Auteurs : Chris G. Mcmahon ; Stanley E. Althof ; Joel M. Kaufman ; Jacques Buvat ; Stephen B. Levine ; Joseph W. Aquilina ; Fisseha Tesfaye ; Margaret Rothman ; David A. Rivas ; Hartmut PorstSource :
- The Journal of Sexual Medicine [ 1743-6095 ] ; 2011-02.
English descriptors
- KwdEn :
- Akathisia, Althof, American studies, American study, Aquilina, Average ielt, Baseline, Beck, Buvat, Cgic, Clin, Clin psychopharmacol, Dapoxetine, Dapoxetine treatment, Discontinuation, Discontinuation syndrome, Dysfunction, Ejaculation, Ejaculatory, Female partners, Fisseha, Fisseha tesfaye, Greater percentage, Hamilton anxiety scale, Hartmut porst, Ielt, Ielt intravaginal ejaculatory latency time, International study, Intravaginal, Issm, Issm criteria, Jacques buvat, Johnson johnson, Kaufman, Latency, Levine, Lifelong, Lpocf, Madrs, Margaret rothman, Mcmahon, Mental disorders, Personal distress, Placebo, Porst, Possible score range baseline, Premature, Premature ejaculation, Psychopharmacol, Randomized, Research development, Reuptake, Rivas, Rothman, Serotonin, Sexual dysfunction, Sexual intercourse, Sexual medicine, Ssri, Standard deviation, Study medication, Suicidal thoughts, Suicidality, Syndrome, Tesfaye, Treatment groups, Urol, Waldinger, Withdrawal assessment period.
- Teeft :
- Akathisia, Althof, American studies, American study, Aquilina, Average ielt, Baseline, Beck, Buvat, Cgic, Clin, Clin psychopharmacol, Dapoxetine, Dapoxetine treatment, Discontinuation, Discontinuation syndrome, Dysfunction, Ejaculation, Ejaculatory, Female partners, Fisseha, Fisseha tesfaye, Greater percentage, Hamilton anxiety scale, Hartmut porst, Ielt, Ielt intravaginal ejaculatory latency time, International study, Intravaginal, Issm, Issm criteria, Jacques buvat, Johnson johnson, Kaufman, Latency, Levine, Lifelong, Lpocf, Madrs, Margaret rothman, Mcmahon, Mental disorders, Personal distress, Placebo, Porst, Possible score range baseline, Premature, Premature ejaculation, Psychopharmacol, Randomized, Research development, Reuptake, Rivas, Rothman, Serotonin, Sexual dysfunction, Sexual intercourse, Sexual medicine, Ssri, Standard deviation, Study medication, Suicidal thoughts, Suicidality, Syndrome, Tesfaye, Treatment groups, Urol, Waldinger, Withdrawal assessment period.
Abstract
Introduction. 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.
Url:
DOI: 10.1111/j.1743-6109.2010.02097.x
Links to Exploration step
ISTEX:0DCD7F0BE68642FAF7BCE4A0391E3BF454615DBCLe document en format XML
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McMahon MD</name><affiliations><json:string>Australian Centre for Sexual Health, St Leonards, New South Wales, Australia</json:string><json:string>E-mail: cmcmahon@acsh.com.au</json:string></affiliations></json:item><json:item><name>Stanley E. Althof PhD</name><affiliations><json:string>University of Miami Miller School of Medicine, West Palm Beach, FL, USA</json:string></affiliations></json:item><json:item><name>Joel M. Kaufman MD</name><affiliations><json:string>Advanced Urology, PC, Urology Research Options, Aurora, CO, USA</json:string></affiliations></json:item><json:item><name>Jacques Buvat MD</name><affiliations><json:string>CETPARP/Le grand Hunier, Lille, France</json:string></affiliations></json:item><json:item><name>Stephen B. Levine MD</name><affiliations><json:string>Case Western Reserve University School of Medicine, Center for Marital and Sexual Health and Department of Psychiatry, Beachwood, OH, USA</json:string></affiliations></json:item><json:item><name>Joseph W. Aquilina MD</name><affiliations><json:string>Johnson & Johnson Pharmaceutical Research & Development, Raritan, NJ, USA</json:string></affiliations></json:item><json:item><name>Fisseha Tesfaye PhD</name><affiliations><json:string>Johnson & Johnson Pharmaceutical Research & Development, Raritan, NJ, USA</json:string></affiliations></json:item><json:item><name>Margaret Rothman PhD</name><affiliations><json:string>Johnson & Johnson Pharmaceutical Services, Raritan, NJ, USA</json:string></affiliations></json:item><json:item><name>David A. Rivas MD</name><affiliations><json:string>Johnson & Johnson Pharmaceutical Services, Raritan, NJ, USA</json:string></affiliations></json:item><json:item><name>Hartmut Porst MD</name><affiliations><json:string>Private Urological Practice, Hamburg, Germany</json:string></affiliations></json:item></author><subject><json:item><lang><json:string>eng</json:string></lang><value>Dapoxetine</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Premature Ejaculation</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Intravaginal Ejaculatory Latency Time</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Control over Ejaculation</value></json:item><json:item><lang><json:string>eng</json:string></lang><value>Distress</value></json:item></subject><articleId><json:string>JSM2097</json:string></articleId><arkIstex>ark:/67375/WNG-PQ1SD7TQ-T</arkIstex><language><json:string>eng</json:string></language><originalGenre><json:string>article</json:string></originalGenre><abstract>Introduction. 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.</abstract><qualityIndicators><score>7.36</score><pdfWordCount>8471</pdfWordCount><pdfCharCount>56936</pdfCharCount><pdfVersion>1.3</pdfVersion><pdfPageCount>16</pdfPageCount><pdfPageSize>594 x 783 pts</pdfPageSize><refBibsNative>true</refBibsNative><abstractWordCount>30</abstractWordCount><abstractCharCount>212</abstractCharCount><keywordCount>5</keywordCount></qualityIndicators><title>Efficacy and Safety of Dapoxetine for the Treatment of Premature Ejaculation: Integrated Analysis of Results from Five Phase 3 Trials</title><pmid><json:string>21059176</json:string></pmid><genre><json:string>article</json:string></genre><host><title>The Journal of Sexual Medicine</title><language><json:string>unknown</json:string></language><doi><json:string>10.1111/(ISSN)1743-6109</json:string></doi><issn><json:string>1743-6095</json:string></issn><eissn><json:string>1743-6109</json:string></eissn><publisherId><json:string>JSM</json:string></publisherId><volume>8</volume><issue>2</issue><pages><first>524</first><last>539</last><total>16</total></pages><genre><json:string>journal</json:string></genre></host><namedEntities><unitex><date><json:string>2011</json:string></date><geogName></geogName><orgName><json:string>Argentina, Brazil, Canada, Israel, Mexico, and South Africa</json:string><json:string>Medicine, Center for Marital</json:string><json:string>Dapoxetine Study Group</json:string><json:string>Hamilton Anxiety Rating Scale (HAM‐A)</json:string><json:string>Society for Sexual Medicine</json:string><json:string>Case Western Reserve University</json:string><json:string>North American, and Asia-Paci</json:string><json:string>Mayo Clinic staff</json:string><json:string>Urology Research Options, Aurora, CO, USA</json:string><json:string>ISSM</json:string><json:string>United States, Europe, China, Taiwan, Korean</json:string><json:string>Germany DOI</json:string><json:string>Sexual Health and Department of Psychiatry, Beachwood, OH, USA</json:string><json:string>American Psychiatric Association</json:string><json:string>The International Society for Sexual Medicine</json:string><json:string>Division of Psychiatry Products</json:string><json:string>World Health Organization</json:string><json:string>for the 3004 study group</json:string></orgName><orgName_funder></orgName_funder><orgName_provider></orgName_provider><persName><json:string>Jacques Buvat</json:string><json:string>Jason McDonough</json:string><json:string>Hartmut Porst</json:string><json:string>H. Ef</json:string><json:string>Subjects</json:string><json:string>Stephen B. Levine</json:string><json:string>Joseph W. Aquilina</json:string><json:string>Margaret Rothman</json:string><json:string>Joel M. Kaufman</json:string><json:string>Fisseha Tesfaye</json:string><json:string>David A. Rivas</json:string><json:string>Stanley E. Althof</json:string></persName><placeName><json:string>United States</json:string><json:string>Australia</json:string><json:string>American</json:string><json:string>Europe</json:string><json:string>America</json:string><json:string>Wales</json:string><json:string>Palm Beach</json:string><json:string>France</json:string><json:string>Lille</json:string></placeName><ref_url></ref_url><ref_bibl><json:string>McMahon et al.</json:string><json:string>[43,44]</json:string><json:string>[34]</json:string><json:string>[6]</json:string><json:string>[33]</json:string><json:string>[8]</json:string><json:string>[28]</json:string><json:string>[14,15]</json:string><json:string>[49,50]</json:string><json:string>[32]</json:string><json:string>[27]</json:string><json:string>[31]</json:string><json:string>[26]</json:string><json:string>[45,46]</json:string><json:string>[52]</json:string><json:string>[7]</json:string><json:string>[25]</json:string><json:string>[1,2]</json:string><json:string>[51]</json:string><json:string>[11,12]</json:string><json:string>[24]</json:string><json:string>[29,30]</json:string><json:string>[4,5]</json:string><json:string>[19]</json:string></ref_bibl><bibl></bibl></unitex></namedEntities><ark><json:string>ark:/67375/WNG-PQ1SD7TQ-T</json:string></ark><categories><wos><json:string>1 - science</json:string><json:string>2 - urology & nephrology</json:string></wos><scienceMetrix><json:string>1 - health sciences</json:string><json:string>2 - clinical medicine</json:string><json:string>3 - obstetrics & reproductive medicine</json:string></scienceMetrix><scopus><json:string>1 - Health Sciences</json:string><json:string>2 - Medicine</json:string><json:string>3 - Urology</json:string><json:string>1 - Health Sciences</json:string><json:string>2 - Medicine</json:string><json:string>3 - Obstetrics and Gynaecology</json:string><json:string>1 - Health Sciences</json:string><json:string>2 - Medicine</json:string><json:string>3 - Reproductive Medicine</json:string></scopus></categories><publicationDate>2011</publicationDate><copyrightDate>2011</copyrightDate><doi><json:string>10.1111/j.1743-6109.2010.02097.x</json:string></doi><id>0DCD7F0BE68642FAF7BCE4A0391E3BF454615DBC</id><score>1</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/document/0DCD7F0BE68642FAF7BCE4A0391E3BF454615DBC/fulltext/pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/document/0DCD7F0BE68642FAF7BCE4A0391E3BF454615DBC/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/0DCD7F0BE68642FAF7BCE4A0391E3BF454615DBC/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main">Efficacy and Safety of Dapoxetine for the Treatment of Premature Ejaculation: Integrated Analysis of Results from Five Phase 3 Trials</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Blackwell Publishing Inc</publisher><pubPlace>Malden, USA</pubPlace><availability><licence>© 2010 International Society for Sexual Medicine</licence></availability><date type="published" when="2011-02"></date></publicationStmt><notesStmt><note type="content-type" subtype="article" source="article" scheme="https://content-type.data.istex.fr/ark:/67375/XTP-6N5SZHKN-D">article</note><note type="publication-type" subtype="journal" scheme="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</note></notesStmt><sourceDesc><biblStruct type="article"><analytic><title level="a" type="main">Efficacy and Safety of Dapoxetine for the Treatment of Premature Ejaculation: Integrated Analysis of Results from Five Phase 3 Trials</title><title level="a" type="short">Dapoxetine for the Treatment of PE</title><author xml:id="author-0000" role="corresp"><persName><forename type="first">Chris G.</forename><surname>McMahon</surname><roleName type="degree">MD</roleName></persName><affiliation>Australian Centre for Sexual Health, St Leonards, New South Wales, Australia<address><country key="AU"></country></address></affiliation><affiliation>Chris G. McMahon, MD, University of Sydney, Australian Center for Sexual Health, Suite 2‐4, Berry Road Medical Center, 1a Berry Road, St Leonards, New South Wales 2071, Australia. Tel: +61 (02) 9437‐3906; Fax: +61 (02) 9906‐5900; E‐mail: cmcmahon@acsh.com.au</affiliation></author><author xml:id="author-0001"><persName><forename type="first">Stanley E.</forename><surname>Althof</surname><roleName type="degree">PhD</roleName></persName><affiliation>University of Miami Miller School of Medicine, West Palm Beach, FL, USA<address><country key="US"></country></address></affiliation></author><author xml:id="author-0002"><persName><forename type="first">Joel M.</forename><surname>Kaufman</surname><roleName type="degree">MD</roleName></persName><affiliation>Advanced Urology, PC, Urology Research Options, Aurora, CO, USA<address><country key="US"></country></address></affiliation></author><author xml:id="author-0003"><persName><forename type="first">Jacques</forename><surname>Buvat</surname><roleName type="degree">MD</roleName></persName><affiliation>CETPARP/Le grand Hunier, Lille, France<address><country key="FR"></country></address></affiliation></author><author xml:id="author-0004"><persName><forename type="first">Stephen B.</forename><surname>Levine</surname><roleName type="degree">MD</roleName></persName><affiliation>Case Western Reserve University School of Medicine, Center for Marital and Sexual Health and Department of Psychiatry, Beachwood, OH, USA<address><country key="US"></country></address></affiliation></author><author xml:id="author-0005"><persName><forename type="first">Joseph W.</forename><surname>Aquilina</surname><roleName type="degree">MD</roleName></persName><affiliation>Johnson & Johnson Pharmaceutical Research & Development, Raritan, NJ, USA<address><country key="US"></country></address></affiliation></author><author xml:id="author-0006"><persName><forename type="first">Fisseha</forename><surname>Tesfaye</surname><roleName type="degree">PhD</roleName></persName><affiliation>Johnson & Johnson Pharmaceutical Research & Development, Raritan, NJ, USA<address><country key="US"></country></address></affiliation></author><author xml:id="author-0007"><persName><forename type="first">Margaret</forename><surname>Rothman</surname><roleName type="degree">PhD</roleName></persName><affiliation>Johnson & Johnson Pharmaceutical Services, Raritan, NJ, USA<address><country key="US"></country></address></affiliation></author><author xml:id="author-0008"><persName><forename type="first">David A.</forename><surname>Rivas</surname><roleName type="degree">MD</roleName></persName><affiliation>Johnson & Johnson Pharmaceutical Services, Raritan, NJ, USA<address><country key="US"></country></address></affiliation></author><author xml:id="author-0009"><persName><forename type="first">Hartmut</forename><surname>Porst</surname><roleName type="degree">MD</roleName></persName><affiliation>Private Urological Practice, Hamburg, Germany<address><country key="DE"></country></address></affiliation></author><idno type="istex">0DCD7F0BE68642FAF7BCE4A0391E3BF454615DBC</idno><idno type="ark">ark:/67375/WNG-PQ1SD7TQ-T</idno><idno type="DOI">10.1111/j.1743-6109.2010.02097.x</idno><idno type="unit">JSM2097</idno><idno type="toTypesetVersion">file:JSM.JSM2097.pdf</idno></analytic><monogr><title level="j" type="main">The Journal of Sexual Medicine</title><title level="j" type="alt">JOURNAL OF SEXUAL MEDICINE</title><idno type="pISSN">1743-6095</idno><idno type="eISSN">1743-6109</idno><idno type="book-DOI">10.1111/(ISSN)1743-6109</idno><idno type="book-part-DOI">10.1111/jsm.2011.8.issue-2</idno><idno type="product">JSM</idno><idno type="publisherDivision">ST</idno><imprint><biblScope unit="vol">8</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="524">524</biblScope><biblScope unit="page" to="539">539</biblScope><biblScope unit="page-count">16</biblScope><publisher>Blackwell Publishing Inc</publisher><pubPlace>Malden, USA</pubPlace><date type="published" when="2011-02"></date></imprint></monogr></biblStruct></sourceDesc></fileDesc><profileDesc><abstract xml:lang="en" style="main"><head>ABSTRACT</head><p><hi rend="bold">Introduction. </hi> 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.</p><p><hi rend="bold">Aim. </hi> To present integrated efficacy and safety data from phase 3 trials of dapoxetine.</p><p><hi rend="bold">Methods. </hi> 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 <hi rend="italic">Diagnostic and Statistical Manual of Mental Disorders</hi>, <hi rend="italic">fourth edition, text revision</hi> 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.</p><p><hi rend="bold">Main Outcome Measures. </hi> End points included stopwatch‐measured IELT, Premature Ejaculation Profile (PEP) items, clinical global impression of change (CGIC) in PE, and adverse events (AEs).</p><p><hi rend="bold">Results. </hi> 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; <hi rend="italic">P</hi> < 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 (<hi rend="italic">P</hi> < 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.</p><p><hi rend="bold">Conclusions. </hi> In this diverse population, dapoxetine significantly improved all aspects of PE and was generally well tolerated. <hi rend="bold">McMahon CG, Althof SE, Kaufman JM, Buvat J, Levine SB, Aquilina JW, Tesfaye F, Rothman M, Rivas DA, Porst H. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: Integrated analysis of results from five phase 3 trials. J Sex Med 2011;8:524–539.</hi></p></abstract><textClass><keywords xml:lang="en"><term xml:id="k1">Dapoxetine</term><term xml:id="k2">Premature Ejaculation</term><term xml:id="k3">Intravaginal Ejaculatory Latency Time</term><term xml:id="k4">Control over Ejaculation</term><term xml:id="k5">Distress</term></keywords><keywords rend="tocHeading1"><term>ORIGINAL RESEARCH</term></keywords><keywords rend="tocHeading2"><term>EJACULATORY DISORDERS</term></keywords></textClass><langUsage><language ident="en"></language></langUsage></profileDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/0DCD7F0BE68642FAF7BCE4A0391E3BF454615DBC/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Wiley, elements deleted: body"><istex:xmlDeclaration>version="1.0" encoding="UTF-8" standalone="yes"</istex:xmlDeclaration><istex:document><component version="2.0" type="serialArticle" xml:lang="en"><header><publicationMeta level="product"><publisherInfo><publisherName>Blackwell Publishing Inc</publisherName><publisherLoc>Malden, USA</publisherLoc></publisherInfo><doi origin="wiley" registered="yes">10.1111/(ISSN)1743-6109</doi><issn type="print">1743-6095</issn><issn type="electronic">1743-6109</issn><idGroup><id type="product" value="JSM"></id><id type="publisherDivision" value="ST"></id></idGroup><titleGroup><title type="main" sort="JOURNAL OF SEXUAL MEDICINE">The Journal of Sexual Medicine</title></titleGroup></publicationMeta><publicationMeta level="part" position="02102"><doi origin="wiley">10.1111/jsm.2011.8.issue-2</doi><numberingGroup><numbering type="journalVolume" number="8">8</numbering><numbering type="journalIssue" number="2">2</numbering></numberingGroup><coverDate startDate="2011-02">February 2011</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="28" status="forIssue"><doi origin="wiley">10.1111/j.1743-6109.2010.02097.x</doi><idGroup><id type="unit" value="JSM2097"></id></idGroup><countGroup><count type="pageTotal" number="16"></count></countGroup><titleGroup><title type="tocHeading1">ORIGINAL RESEARCH</title><title type="tocHeading2">EJACULATORY DISORDERS</title></titleGroup><copyright>© 2010 International Society for Sexual Medicine</copyright><eventGroup><event type="xmlConverted" agent="Converter:BPG_TO_WML3G version:2.4.4 mode:FullText" date="2011-02-01"></event><event type="publishedOnlineEarlyUnpaginated" date="2010-11-08"></event><event type="firstOnline" date="2010-11-08"></event><event type="publishedOnlineFinalForm" date="2011-02-01"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:3.8.8" date="2014-02-01"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.1.7 mode:FullText,remove_FC" date="2014-11-04"></event></eventGroup><numberingGroup><numbering type="pageFirst" number="524">524</numbering><numbering type="pageLast" number="539">539</numbering></numberingGroup><correspondenceTo>Chris G. McMahon, MD, University of Sydney, Australian Center for Sexual Health, Suite 2‐4, Berry Road Medical Center, 1a Berry Road, St Leonards, New South Wales 2071, Australia. Tel: +61 (02) 9437‐3906; Fax: +61 (02) 9906‐5900; E‐mail: <email>cmcmahon@acsh.com.au</email></correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:JSM.JSM2097.pdf"></link></linkGroup></publicationMeta><contentMeta><countGroup><count type="figureTotal" number="3"></count><count type="tableTotal" number="7"></count><count type="formulaTotal" number="0"></count><count type="referenceTotal" number="52"></count><count type="wordTotal" number="10312"></count><count type="linksPubMed" number="0"></count><count type="linksCrossRef" number="0"></count></countGroup><titleGroup><title type="main">Efficacy and Safety of Dapoxetine for the Treatment of Premature Ejaculation: Integrated Analysis of Results from Five Phase 3 Trials</title><title type="shortAuthors">McMahon et al.</title><title type="short">Dapoxetine for the Treatment of PE</title></titleGroup><creators><creator creatorRole="author" xml:id="cr1" affiliationRef="#a1" corresponding="yes"><personName><givenNames>Chris G.</givenNames><familyName>McMahon</familyName><degrees>MD</degrees></personName></creator><creator creatorRole="author" xml:id="cr2" affiliationRef="#a2"><personName><givenNames>Stanley E.</givenNames><familyName>Althof</familyName><degrees>PhD</degrees></personName></creator><creator creatorRole="author" xml:id="cr3" affiliationRef="#a3"><personName><givenNames>Joel M.</givenNames><familyName>Kaufman</familyName><degrees>MD</degrees></personName></creator><creator creatorRole="author" xml:id="cr4" affiliationRef="#a4"><personName><givenNames>Jacques</givenNames><familyName>Buvat</familyName><degrees>MD</degrees></personName></creator><creator creatorRole="author" xml:id="cr5" affiliationRef="#a5"><personName><givenNames>Stephen B.</givenNames><familyName>Levine</familyName><degrees>MD</degrees></personName></creator><creator creatorRole="author" xml:id="cr6" affiliationRef="#a6"><personName><givenNames>Joseph W.</givenNames><familyName>Aquilina</familyName><degrees>MD</degrees></personName></creator><creator creatorRole="author" xml:id="cr7" affiliationRef="#a6"><personName><givenNames>Fisseha</givenNames><familyName>Tesfaye</familyName><degrees>PhD</degrees></personName></creator><creator creatorRole="author" xml:id="cr8" affiliationRef="#a7"><personName><givenNames>Margaret</givenNames><familyName>Rothman</familyName><degrees>PhD</degrees></personName></creator><creator creatorRole="author" xml:id="cr9" affiliationRef="#a7"><personName><givenNames>David A.</givenNames><familyName>Rivas</familyName><degrees>MD</degrees></personName></creator><creator creatorRole="author" xml:id="cr10" affiliationRef="#a8"><personName><givenNames>Hartmut</givenNames><familyName>Porst</familyName><degrees>MD</degrees></personName></creator></creators><affiliationGroup><affiliation xml:id="a1" countryCode="AU"><unparsedAffiliation>Australian Centre for Sexual Health, St Leonards, New South Wales, Australia</unparsedAffiliation></affiliation><affiliation xml:id="a2" countryCode="US"><unparsedAffiliation>University of Miami Miller School of Medicine, West Palm Beach, FL, USA</unparsedAffiliation></affiliation><affiliation xml:id="a3" countryCode="US"><unparsedAffiliation>Advanced Urology, PC, Urology Research Options, Aurora, CO, USA</unparsedAffiliation></affiliation><affiliation xml:id="a4" countryCode="FR"><unparsedAffiliation>CETPARP/Le grand Hunier, Lille, France</unparsedAffiliation></affiliation><affiliation xml:id="a5" countryCode="US"><unparsedAffiliation>Case Western Reserve University School of Medicine, Center for Marital and Sexual Health and Department of Psychiatry, Beachwood, OH, USA</unparsedAffiliation></affiliation><affiliation xml:id="a6" countryCode="US"><unparsedAffiliation>Johnson & Johnson Pharmaceutical Research & Development, Raritan, NJ, USA</unparsedAffiliation></affiliation><affiliation xml:id="a7" countryCode="US"><unparsedAffiliation>Johnson & Johnson Pharmaceutical Services, Raritan, NJ, USA</unparsedAffiliation></affiliation><affiliation xml:id="a8" countryCode="DE"><unparsedAffiliation>Private Urological Practice, Hamburg, Germany</unparsedAffiliation></affiliation></affiliationGroup><keywordGroup xml:lang="en"><keyword xml:id="k1">Dapoxetine</keyword><keyword xml:id="k2">Premature Ejaculation</keyword><keyword xml:id="k3">Intravaginal Ejaculatory Latency Time</keyword><keyword xml:id="k4">Control over Ejaculation</keyword><keyword xml:id="k5">Distress</keyword></keywordGroup><abstractGroup><abstract type="main" xml:lang="en"><title type="main">ABSTRACT</title><p><b>Introduction. </b> 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.</p><p><b>Aim. </b> To present integrated efficacy and safety data from phase 3 trials of dapoxetine.</p><p><b>Methods. </b> 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 <i>Diagnostic and Statistical Manual of Mental Disorders</i>, <i>fourth edition, text revision</i> 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.</p><p><b>Main Outcome Measures. </b> End points included stopwatch‐measured IELT, Premature Ejaculation Profile (PEP) items, clinical global impression of change (CGIC) in PE, and adverse events (AEs).</p><p><b>Results. </b> 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; <i>P</i> < 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 (<i>P</i> < 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.</p><p><b>Conclusions. </b> In this diverse population, dapoxetine significantly improved all aspects of PE and was generally well tolerated. <b>McMahon CG, Althof SE, Kaufman JM, Buvat J, Levine SB, Aquilina JW, Tesfaye F, Rothman M, Rivas DA, Porst H. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: Integrated analysis of results from five phase 3 trials. J Sex Med 2011;8:524–539.</b></p></abstract></abstractGroup></contentMeta></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Efficacy and Safety of Dapoxetine for the Treatment of Premature Ejaculation: Integrated Analysis of Results from Five Phase 3 Trials</title></titleInfo><titleInfo type="abbreviated" lang="en"><title>Dapoxetine for the Treatment of PE</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Efficacy and Safety of Dapoxetine for the Treatment of Premature Ejaculation: Integrated Analysis of Results from Five Phase 3 Trials</title></titleInfo><name type="personal"><namePart type="given">Chris G.</namePart><namePart type="family">McMahon</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Australian Centre for Sexual Health, St Leonards, New South Wales, Australia</affiliation><affiliation>E-mail: cmcmahon@acsh.com.au</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Stanley E.</namePart><namePart type="family">Althof</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>University of Miami Miller School of Medicine, West Palm Beach, FL, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Joel M.</namePart><namePart type="family">Kaufman</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Advanced Urology, PC, Urology Research Options, Aurora, CO, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Jacques</namePart><namePart type="family">Buvat</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>CETPARP/Le grand Hunier, Lille, France</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Stephen B.</namePart><namePart type="family">Levine</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Case Western Reserve University School of Medicine, Center for Marital and Sexual Health and Department of Psychiatry, Beachwood, OH, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Joseph W.</namePart><namePart type="family">Aquilina</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Johnson & Johnson Pharmaceutical Research & Development, Raritan, NJ, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Fisseha</namePart><namePart type="family">Tesfaye</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Johnson & Johnson Pharmaceutical Research & Development, Raritan, NJ, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Margaret</namePart><namePart type="family">Rothman</namePart><namePart type="termsOfAddress">PhD</namePart><affiliation>Johnson & Johnson Pharmaceutical Services, Raritan, NJ, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">David A.</namePart><namePart type="family">Rivas</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Johnson & Johnson Pharmaceutical Services, Raritan, NJ, USA</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Hartmut</namePart><namePart type="family">Porst</namePart><namePart type="termsOfAddress">MD</namePart><affiliation>Private Urological Practice, Hamburg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article" authority="ISTEX" authorityURI="https://content-type.data.istex.fr" valueURI="https://content-type.data.istex.fr/ark:/67375/XTP-6N5SZHKN-D">article</genre><originInfo><publisher>Blackwell Publishing Inc</publisher><place><placeTerm type="text">Malden, USA</placeTerm></place><dateIssued encoding="w3cdtf">2011-02</dateIssued><copyrightDate encoding="w3cdtf">2011</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><extent unit="figures">3</extent><extent unit="tables">7</extent><extent unit="formulas">0</extent><extent unit="references">52</extent><extent unit="linksCrossRef">0</extent><extent unit="words">10312</extent></physicalDescription><abstract>Introduction. 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.</abstract><abstract>Aim. To present integrated efficacy and safety data from phase 3 trials of dapoxetine.</abstract><abstract>Methods. 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.</abstract><abstract>Main Outcome Measures. End points included stopwatch‐measured IELT, Premature Ejaculation Profile (PEP) items, clinical global impression of change (CGIC) in PE, and adverse events (AEs).</abstract><abstract>Results. 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.</abstract><abstract>Conclusions. In this diverse population, dapoxetine significantly improved all aspects of PE and was generally well tolerated. McMahon CG, Althof SE, Kaufman JM, Buvat J, Levine SB, Aquilina JW, Tesfaye F, Rothman M, Rivas DA, Porst H. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: Integrated analysis of results from five phase 3 trials. J Sex Med 2011;8:524–539.</abstract><subject lang="en"><genre>keywords</genre><topic>Dapoxetine</topic><topic>Premature Ejaculation</topic><topic>Intravaginal Ejaculatory Latency Time</topic><topic>Control over Ejaculation</topic><topic>Distress</topic></subject><relatedItem type="host"><titleInfo><title>The Journal of Sexual Medicine</title></titleInfo><genre type="journal" authority="ISTEX" authorityURI="https://publication-type.data.istex.fr" valueURI="https://publication-type.data.istex.fr/ark:/67375/JMC-0GLKJH51-B">journal</genre><identifier type="ISSN">1743-6095</identifier><identifier type="eISSN">1743-6109</identifier><identifier type="DOI">10.1111/(ISSN)1743-6109</identifier><identifier type="PublisherID">JSM</identifier><part><date>2011</date><detail type="volume"><caption>vol.</caption><number>8</number></detail><detail type="issue"><caption>no.</caption><number>2</number></detail><extent unit="pages"><start>524</start><end>539</end><total>16</total></extent></part></relatedItem><identifier type="istex">0DCD7F0BE68642FAF7BCE4A0391E3BF454615DBC</identifier><identifier type="ark">ark:/67375/WNG-PQ1SD7TQ-T</identifier><identifier type="DOI">10.1111/j.1743-6109.2010.02097.x</identifier><identifier type="ArticleID">JSM2097</identifier><accessCondition type="use and reproduction" contentType="copyright">© 2010 International Society for Sexual Medicine</accessCondition><recordInfo><recordContentSource authority="ISTEX" authorityURI="https://loaded-corpus.data.istex.fr" valueURI="https://loaded-corpus.data.istex.fr/ark:/67375/XBH-L0C46X92-X">wiley</recordContentSource><recordOrigin>Blackwell Publishing Inc</recordOrigin></recordInfo></mods><json:item><extension>json</extension><original>false</original><mimetype>application/json</mimetype><uri>https://api.istex.fr/document/0DCD7F0BE68642FAF7BCE4A0391E3BF454615DBC/metadata/json</uri></json:item></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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