Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double‐blind, multicentre study
Identifieur interne : 001D65 ( Istex/Corpus ); précédent : 001D64; suivant : 001D66Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double‐blind, multicentre study
Auteurs : M. Choo ; J. Z. Lee ; J. B. Lee ; Y. Kim ; H. C. Jung ; K. Lee ; J. C. Kim ; J. T. Seo ; J. Paick ; H. Kim ; Y. G. Na ; J. G. LeeSource :
- International Journal of Clinical Practice [ 1368-5031 ] ; 2008-11.
Abstract
Purpose: We assessed the efficacy and safety of solifenacin compared with tolterodine for treatment of overactive bladder (OAB) in Korean patients. Materials and methods: The study was randomised, double‐blind, tolterodine‐controlled trial in Korea. Patients had average frequency of ≥ 8 voids per 24 h and episodes of urgency or urgency incontinence ≥ 3 during 3‐day voiding diary period. Patients were randomised to 12‐week double‐blind treatment with either tolterodine immediate release (IR) 2 mg twice daily (TOL4) or solifenacin 5 mg (SOL5) or 10 mg (SOL10) once daily. The outcome measure was mean change in daily micturition frequency, volume, daily frequency of urgency incontinence, urgency and nocturia from baseline to week 12. Quality of life was assessed using the King’s Health Questionnaire. Results: A total of 357 were randomised and 329 were evaluated for efficacy. All voiding parameters recorded in micturition diary improved after treatment in all three groups. Mean changes in volume voided were 19.30 ml (26.69%) in TOL4, 30.37 ml (25.89%) in SOL5 and 37.12 ml (33.36%) in SOL10 group (p = 0.03). Speed of onset of SOL10 efficacy on urgency incontinence was faster than that of SOL5 and TOL4. Quality of life improved in all three groups. Dry mouth was the most common adverse event; its incidence was the lowest in SOL5 group (7.63%, compared with 19.49% and 18.64% in SOL10 and TOL4 groups respectively). Conclusions: Solifenacin succinate 5 and 10 mg once daily improve OAB symptoms with acceptable tolerability levels compared with tolterodine IR 4 mg. Solifenacin 5 mg is a recommended starting dose in Korean patients with OAB.
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DOI: 10.1111/j.1742-1241.2008.01898.x
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<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double‐blind, multicentre study</title><author><name sortKey="Choo, M" sort="Choo, M" uniqKey="Choo M" first="M." last="Choo">M. Choo</name><affiliation><mods:affiliation>Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea</mods:affiliation></affiliation></author><author><name sortKey="Lee, J Z" sort="Lee, J Z" uniqKey="Lee J" first="J. Z." last="Lee">J. Z. Lee</name><affiliation><mods:affiliation>Department of Urology, College of Medicine, Pusan National University, Busan, Korea</mods:affiliation></affiliation></author><author><name sortKey="Lee, J B" sort="Lee, J B" uniqKey="Lee J" first="J. B." last="Lee">J. B. Lee</name><affiliation><mods:affiliation>Department of Urology, National Medical Center, Seoul, Korea</mods:affiliation></affiliation></author><author><name sortKey="Kim, Y" sort="Kim, Y" uniqKey="Kim Y" first="Y." last="Kim">Y. Kim</name><affiliation><mods:affiliation>Department of Urology, Soonchunhyang University Bucheon Hospital, Bucheon, Korea</mods:affiliation></affiliation></author><author><name sortKey="Jung, H C" sort="Jung, H C" uniqKey="Jung H" first="H. C." last="Jung">H. C. Jung</name><affiliation><mods:affiliation>Department of Urology, Yeungnam University Hospital, Daegu, Korea</mods:affiliation></affiliation></author><author><name sortKey="Lee, K" sort="Lee, K" uniqKey="Lee K" first="K." last="Lee">K. Lee</name><affiliation><mods:affiliation>Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea</mods:affiliation></affiliation></author><author><name sortKey="Kim, J C" sort="Kim, J C" uniqKey="Kim J" first="J. C." last="Kim">J. C. Kim</name><affiliation><mods:affiliation>Department of Urology, College of Medicine, The Catholic University of Korea, Seoul, Korea</mods:affiliation></affiliation></author><author><name sortKey="Seo, J T" sort="Seo, J T" uniqKey="Seo J" first="J. T." last="Seo">J. T. Seo</name><affiliation><mods:affiliation>Department of Urology, Jeil Hospital, Kwandong University College of Medicine, Seoul, Korea</mods:affiliation></affiliation></author><author><name sortKey="Paick, J" sort="Paick, J" uniqKey="Paick J" first="J." last="Paick">J. Paick</name><affiliation><mods:affiliation>Department of Urology, Seoul National University College of Medicine, Seoul Korea</mods:affiliation></affiliation></author><author><name sortKey="Kim, H" sort="Kim, H" uniqKey="Kim H" first="H." last="Kim">H. Kim</name><affiliation><mods:affiliation>Department of Urology, Dankook University College of Medicine, Cheonan, Korea</mods:affiliation></affiliation></author><author><name sortKey="Na, Y G" sort="Na, Y G" uniqKey="Na Y" first="Y. G." last="Na">Y. G. Na</name><affiliation><mods:affiliation>Department of Urology, Chungnam National University College of Medicine, Daejeon, Korea</mods:affiliation></affiliation></author><author><name sortKey="Lee, J G" sort="Lee, J G" uniqKey="Lee J" first="J. G." last="Lee">J. G. Lee</name><affiliation><mods:affiliation>Department of Urology, College of Medicine, Korea University, Seoul, Korea</mods:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:09A500C4C70E8A462DC009A9C386CA27B81C751D</idno><date when="2008" year="2008">2008</date><idno type="doi">10.1111/j.1742-1241.2008.01898.x</idno><idno type="url">https://api.istex.fr/document/09A500C4C70E8A462DC009A9C386CA27B81C751D/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">001D65</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double‐blind, multicentre study</title><author><name sortKey="Choo, M" sort="Choo, M" uniqKey="Choo M" first="M." last="Choo">M. Choo</name><affiliation><mods:affiliation>Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea</mods:affiliation></affiliation></author><author><name sortKey="Lee, J Z" sort="Lee, J Z" uniqKey="Lee J" first="J. Z." last="Lee">J. Z. Lee</name><affiliation><mods:affiliation>Department of Urology, College of Medicine, Pusan National University, Busan, Korea</mods:affiliation></affiliation></author><author><name sortKey="Lee, J B" sort="Lee, J B" uniqKey="Lee J" first="J. B." last="Lee">J. B. Lee</name><affiliation><mods:affiliation>Department of Urology, National Medical Center, Seoul, Korea</mods:affiliation></affiliation></author><author><name sortKey="Kim, Y" sort="Kim, Y" uniqKey="Kim Y" first="Y." last="Kim">Y. Kim</name><affiliation><mods:affiliation>Department of Urology, Soonchunhyang University Bucheon Hospital, Bucheon, Korea</mods:affiliation></affiliation></author><author><name sortKey="Jung, H C" sort="Jung, H C" uniqKey="Jung H" first="H. C." last="Jung">H. C. Jung</name><affiliation><mods:affiliation>Department of Urology, Yeungnam University Hospital, Daegu, Korea</mods:affiliation></affiliation></author><author><name sortKey="Lee, K" sort="Lee, K" uniqKey="Lee K" first="K." last="Lee">K. Lee</name><affiliation><mods:affiliation>Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea</mods:affiliation></affiliation></author><author><name sortKey="Kim, J C" sort="Kim, J C" uniqKey="Kim J" first="J. C." last="Kim">J. C. Kim</name><affiliation><mods:affiliation>Department of Urology, College of Medicine, The Catholic University of Korea, Seoul, Korea</mods:affiliation></affiliation></author><author><name sortKey="Seo, J T" sort="Seo, J T" uniqKey="Seo J" first="J. T." last="Seo">J. T. Seo</name><affiliation><mods:affiliation>Department of Urology, Jeil Hospital, Kwandong University College of Medicine, Seoul, Korea</mods:affiliation></affiliation></author><author><name sortKey="Paick, J" sort="Paick, J" uniqKey="Paick J" first="J." last="Paick">J. Paick</name><affiliation><mods:affiliation>Department of Urology, Seoul National University College of Medicine, Seoul Korea</mods:affiliation></affiliation></author><author><name sortKey="Kim, H" sort="Kim, H" uniqKey="Kim H" first="H." last="Kim">H. Kim</name><affiliation><mods:affiliation>Department of Urology, Dankook University College of Medicine, Cheonan, Korea</mods:affiliation></affiliation></author><author><name sortKey="Na, Y G" sort="Na, Y G" uniqKey="Na Y" first="Y. G." last="Na">Y. G. Na</name><affiliation><mods:affiliation>Department of Urology, Chungnam National University College of Medicine, Daejeon, Korea</mods:affiliation></affiliation></author><author><name sortKey="Lee, J G" sort="Lee, J G" uniqKey="Lee J" first="J. G." last="Lee">J. G. Lee</name><affiliation><mods:affiliation>Department of Urology, College of Medicine, Korea University, Seoul, Korea</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">International Journal of Clinical Practice</title><idno type="ISSN">1368-5031</idno><idno type="eISSN">1742-1241</idno><imprint><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="2008-11">2008-11</date><biblScope unit="volume">62</biblScope><biblScope unit="issue">11</biblScope><biblScope unit="page" from="1675">1675</biblScope><biblScope unit="page" to="1683">1683</biblScope></imprint><idno type="ISSN">1368-5031</idno></series><idno type="istex">09A500C4C70E8A462DC009A9C386CA27B81C751D</idno><idno type="DOI">10.1111/j.1742-1241.2008.01898.x</idno><idno type="ArticleID">IJCP1898</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">1368-5031</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purpose: We assessed the efficacy and safety of solifenacin compared with tolterodine for treatment of overactive bladder (OAB) in Korean patients. Materials and methods: The study was randomised, double‐blind, tolterodine‐controlled trial in Korea. Patients had average frequency of ≥ 8 voids per 24 h and episodes of urgency or urgency incontinence ≥ 3 during 3‐day voiding diary period. Patients were randomised to 12‐week double‐blind treatment with either tolterodine immediate release (IR) 2 mg twice daily (TOL4) or solifenacin 5 mg (SOL5) or 10 mg (SOL10) once daily. The outcome measure was mean change in daily micturition frequency, volume, daily frequency of urgency incontinence, urgency and nocturia from baseline to week 12. Quality of life was assessed using the King’s Health Questionnaire. Results: A total of 357 were randomised and 329 were evaluated for efficacy. All voiding parameters recorded in micturition diary improved after treatment in all three groups. Mean changes in volume voided were 19.30 ml (26.69%) in TOL4, 30.37 ml (25.89%) in SOL5 and 37.12 ml (33.36%) in SOL10 group (p = 0.03). Speed of onset of SOL10 efficacy on urgency incontinence was faster than that of SOL5 and TOL4. Quality of life improved in all three groups. Dry mouth was the most common adverse event; its incidence was the lowest in SOL5 group (7.63%, compared with 19.49% and 18.64% in SOL10 and TOL4 groups respectively). Conclusions: Solifenacin succinate 5 and 10 mg once daily improve OAB symptoms with acceptable tolerability levels compared with tolterodine IR 4 mg. Solifenacin 5 mg is a recommended starting dose in Korean patients with OAB.</div></front></TEI><istex><corpusName>wiley</corpusName><author><json:item><name>M.‐S Choo</name><affiliations><json:string>Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea</json:string></affiliations></json:item><json:item><name>J. Z. Lee</name><affiliations><json:string>Department of Urology, College of Medicine, Pusan National University, Busan, Korea</json:string></affiliations></json:item><json:item><name>J. B. Lee</name><affiliations><json:string>Department of Urology, National Medical Center, Seoul, Korea</json:string></affiliations></json:item><json:item><name>Y.‐H. Kim</name><affiliations><json:string>Department of Urology, Soonchunhyang University Bucheon Hospital, Bucheon, Korea</json:string></affiliations></json:item><json:item><name>H. C. Jung</name><affiliations><json:string>Department of Urology, Yeungnam University Hospital, Daegu, Korea</json:string></affiliations></json:item><json:item><name>K.‐S. Lee</name><affiliations><json:string>Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea</json:string></affiliations></json:item><json:item><name>J. C. Kim</name><affiliations><json:string>Department of Urology, College of Medicine, The Catholic University of Korea, Seoul, Korea</json:string></affiliations></json:item><json:item><name>J. T. Seo</name><affiliations><json:string>Department of Urology, Jeil Hospital, Kwandong University College of Medicine, Seoul, Korea</json:string></affiliations></json:item><json:item><name>J.‐S. Paick</name><affiliations><json:string>Department of Urology, Seoul National University College of Medicine, Seoul Korea</json:string></affiliations></json:item><json:item><name>H.‐J. Kim</name><affiliations><json:string>Department of Urology, Dankook University College of Medicine, Cheonan, Korea</json:string></affiliations></json:item><json:item><name>Y. G. Na</name><affiliations><json:string>Department of Urology, Chungnam National University College of Medicine, Daejeon, Korea</json:string></affiliations></json:item><json:item><name>J. G. Lee</name><affiliations><json:string>Department of Urology, College of Medicine, Korea University, Seoul, Korea</json:string></affiliations></json:item></author><articleId><json:string>IJCP1898</json:string></articleId><language><json:string>eng</json:string></language><abstract>Purpose: We assessed the efficacy and safety of solifenacin compared with tolterodine for treatment of overactive bladder (OAB) in Korean patients. Materials and methods: The study was randomised, double‐blind, tolterodine‐controlled trial in Korea. Patients had average frequency of ≥ 8 voids per 24 h and episodes of urgency or urgency incontinence ≥ 3 during 3‐day voiding diary period. Patients were randomised to 12‐week double‐blind treatment with either tolterodine immediate release (IR) 2 mg twice daily (TOL4) or solifenacin 5 mg (SOL5) or 10 mg (SOL10) once daily. The outcome measure was mean change in daily micturition frequency, volume, daily frequency of urgency incontinence, urgency and nocturia from baseline to week 12. Quality of life was assessed using the King’s Health Questionnaire. Results: A total of 357 were randomised and 329 were evaluated for efficacy. All voiding parameters recorded in micturition diary improved after treatment in all three groups. Mean changes in volume voided were 19.30 ml (26.69%) in TOL4, 30.37 ml (25.89%) in SOL5 and 37.12 ml (33.36%) in SOL10 group (p = 0.03). Speed of onset of SOL10 efficacy on urgency incontinence was faster than that of SOL5 and TOL4. Quality of life improved in all three groups. Dry mouth was the most common adverse event; its incidence was the lowest in SOL5 group (7.63%, compared with 19.49% and 18.64% in SOL10 and TOL4 groups respectively). Conclusions: Solifenacin succinate 5 and 10 mg once daily improve OAB symptoms with acceptable tolerability levels compared with tolterodine IR 4 mg. Solifenacin 5 mg is a recommended starting dose in Korean patients with OAB.</abstract><qualityIndicators><score>7.541</score><pdfVersion>1.3</pdfVersion><pdfPageSize>595.276 x 782.362 pts</pdfPageSize><refBibsNative>true</refBibsNative><keywordCount>0</keywordCount><abstractCharCount>1661</abstractCharCount><pdfWordCount>4565</pdfWordCount><pdfCharCount>30855</pdfCharCount><pdfPageCount>9</pdfPageCount><abstractWordCount>248</abstractWordCount></qualityIndicators><title>Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double‐blind, multicentre study</title><genre><json:string>article</json:string></genre><host><volume>62</volume><publisherId><json:string>IJCP</json:string></publisherId><pages><total>9</total><last>1683</last><first>1675</first></pages><issn><json:string>1368-5031</json:string></issn><issue>11</issue><genre><json:string>Journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1742-1241</json:string></eissn><title>International Journal of Clinical Practice</title><doi><json:string>10.1111/(ISSN)1742-1241</json:string></doi></host><publicationDate>2008</publicationDate><copyrightDate>2008</copyrightDate><doi><json:string>10.1111/j.1742-1241.2008.01898.x</json:string></doi><id>09A500C4C70E8A462DC009A9C386CA27B81C751D</id><fulltext><json:item><original>true</original><mimetype>application/pdf</mimetype><extension>pdf</extension><uri>https://api.istex.fr/document/09A500C4C70E8A462DC009A9C386CA27B81C751D/fulltext/pdf</uri></json:item><json:item><original>false</original><mimetype>application/zip</mimetype><extension>zip</extension><uri>https://api.istex.fr/document/09A500C4C70E8A462DC009A9C386CA27B81C751D/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/09A500C4C70E8A462DC009A9C386CA27B81C751D/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double‐blind, multicentre study</title></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><availability><p>WILEY</p></availability><date>2008</date></publicationStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double‐blind, multicentre study</title><author><persName><forename type="first">M.‐S</forename><surname>Choo</surname></persName><affiliation>Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea</affiliation></author><author><persName><forename type="first">J. Z.</forename><surname>Lee</surname></persName><affiliation>Department of Urology, College of Medicine, Pusan National University, Busan, Korea</affiliation></author><author><persName><forename type="first">J. B.</forename><surname>Lee</surname></persName><affiliation>Department of Urology, National Medical Center, Seoul, Korea</affiliation></author><author><persName><forename type="first">Y.‐H.</forename><surname>Kim</surname></persName><affiliation>Department of Urology, Soonchunhyang University Bucheon Hospital, Bucheon, Korea</affiliation></author><author><persName><forename type="first">H. C.</forename><surname>Jung</surname></persName><affiliation>Department of Urology, Yeungnam University Hospital, Daegu, Korea</affiliation></author><author><persName><forename type="first">K.‐S.</forename><surname>Lee</surname></persName><affiliation>Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea</affiliation></author><author><persName><forename type="first">J. C.</forename><surname>Kim</surname></persName><affiliation>Department of Urology, College of Medicine, The Catholic University of Korea, Seoul, Korea</affiliation></author><author><persName><forename type="first">J. T.</forename><surname>Seo</surname></persName><affiliation>Department of Urology, Jeil Hospital, Kwandong University College of Medicine, Seoul, Korea</affiliation></author><author><persName><forename type="first">J.‐S.</forename><surname>Paick</surname></persName><affiliation>Department of Urology, Seoul National University College of Medicine, Seoul Korea</affiliation></author><author><persName><forename type="first">H.‐J.</forename><surname>Kim</surname></persName><affiliation>Department of Urology, Dankook University College of Medicine, Cheonan, Korea</affiliation></author><author><persName><forename type="first">Y. G.</forename><surname>Na</surname></persName><affiliation>Department of Urology, Chungnam National University College of Medicine, Daejeon, Korea</affiliation></author><author><persName><forename type="first">J. G.</forename><surname>Lee</surname></persName><affiliation>Department of Urology, College of Medicine, Korea University, Seoul, Korea</affiliation></author></analytic><monogr><title level="j">International Journal of Clinical Practice</title><idno type="pISSN">1368-5031</idno><idno type="eISSN">1742-1241</idno><idno type="DOI">10.1111/(ISSN)1742-1241</idno><imprint><publisher>Blackwell Publishing Ltd</publisher><pubPlace>Oxford, UK</pubPlace><date type="published" when="2008-11"></date><biblScope unit="volume">62</biblScope><biblScope unit="issue">11</biblScope><biblScope unit="page" from="1675">1675</biblScope><biblScope unit="page" to="1683">1683</biblScope></imprint></monogr><idno type="istex">09A500C4C70E8A462DC009A9C386CA27B81C751D</idno><idno type="DOI">10.1111/j.1742-1241.2008.01898.x</idno><idno type="ArticleID">IJCP1898</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>2008</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Purpose: We assessed the efficacy and safety of solifenacin compared with tolterodine for treatment of overactive bladder (OAB) in Korean patients. Materials and methods: The study was randomised, double‐blind, tolterodine‐controlled trial in Korea. Patients had average frequency of ≥ 8 voids per 24 h and episodes of urgency or urgency incontinence ≥ 3 during 3‐day voiding diary period. Patients were randomised to 12‐week double‐blind treatment with either tolterodine immediate release (IR) 2 mg twice daily (TOL4) or solifenacin 5 mg (SOL5) or 10 mg (SOL10) once daily. The outcome measure was mean change in daily micturition frequency, volume, daily frequency of urgency incontinence, urgency and nocturia from baseline to week 12. Quality of life was assessed using the King’s Health Questionnaire. Results: A total of 357 were randomised and 329 were evaluated for efficacy. All voiding parameters recorded in micturition diary improved after treatment in all three groups. Mean changes in volume voided were 19.30 ml (26.69%) in TOL4, 30.37 ml (25.89%) in SOL5 and 37.12 ml (33.36%) in SOL10 group (p = 0.03). Speed of onset of SOL10 efficacy on urgency incontinence was faster than that of SOL5 and TOL4. Quality of life improved in all three groups. Dry mouth was the most common adverse event; its incidence was the lowest in SOL5 group (7.63%, compared with 19.49% and 18.64% in SOL10 and TOL4 groups respectively). Conclusions: Solifenacin succinate 5 and 10 mg once daily improve OAB symptoms with acceptable tolerability levels compared with tolterodine IR 4 mg. Solifenacin 5 mg is a recommended starting dose in Korean patients with OAB.</p></abstract></profileDesc><revisionDesc><change when="2008-11">Published</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><original>false</original><mimetype>text/plain</mimetype><extension>txt</extension><uri>https://api.istex.fr/document/09A500C4C70E8A462DC009A9C386CA27B81C751D/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 Ltd</publisherName><publisherLoc>Oxford, UK</publisherLoc></publisherInfo><doi origin="wiley" registered="yes">10.1111/(ISSN)1742-1241</doi><issn type="print">1368-5031</issn><issn type="electronic">1742-1241</issn><idGroup><id type="product" value="IJCP"></id><id type="publisherDivision" value="ST"></id></idGroup><titleGroup><title type="main" sort="INTERNATIONAL JOURNAL OF CLINICAL PRACTICE">International Journal of Clinical Practice</title></titleGroup></publicationMeta><publicationMeta level="part" position="11011"><doi origin="wiley">10.1111/ijcp.2008.62.issue-11</doi><numberingGroup><numbering type="journalVolume" number="62">62</numbering><numbering type="journalIssue" number="11">11</numbering></numberingGroup><coverDate startDate="2008-11">November 2008</coverDate></publicationMeta><publicationMeta level="unit" type="article" position="9" status="forIssue" accessType="open"><doi origin="wiley">10.1111/j.1742-1241.2008.01898.x</doi><idGroup><id type="unit" value="IJCP1898"></id><id type="supplier" value="1898"></id></idGroup><countGroup><count type="pageTotal" number="9"></count></countGroup><titleGroup><title type="tocHeading1">Overactive Bladder</title></titleGroup><copyright>© 2008 The Authors. Journal compilation © 2008 Blackwell Publishing Ltd</copyright><eventGroup><event type="firstOnline" date="2008-10-15"></event><event type="publishedOnlineFinalForm" date="2008-10-15"></event><event type="xmlConverted" agent="Converter:BPG_TO_WML3G version:2.3.2 mode:FullText source:FullText result:FullText" date="2010-03-06"></event><event type="xmlConverted" agent="Converter:WILEY_ML3G_TO_WILEY_ML3GV2 version:4.0.1" date="2014-03-13"></event><event type="xmlConverted" agent="Converter:WML3G_To_WML3G version:4.1.7 mode:FullText,remove_FC" date="2014-10-24"></event></eventGroup><numberingGroup><numbering type="pageFirst" number="1675">1675</numbering><numbering type="pageLast" number="1683">1683</numbering></numberingGroup><correspondenceTo>Jeong Gu Lee,
Department of Urology, Korea University Anam Hospital, 126‐1, 5‐ga, anam‐dong, Seongbuk‐gu, Seoul 136‐705, Korea
Tel.: + 82 2 920 5683
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Email: <email>jeongkl@kumc.or.kr</email></correspondenceTo><linkGroup><link type="toTypesetVersion" href="file:IJCP.IJCP1898.pdf"></link></linkGroup></publicationMeta><contentMeta><unparsedEditorialHistory>Paper received April 2008, accepted August 2008</unparsedEditorialHistory><countGroup><count type="figureTotal" number="2"></count><count type="tableTotal" number="5"></count></countGroup><titleGroup><title type="main">Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double‐blind, multicentre study</title><title type="short">Solifenacin succinate in Korean patients with OAB</title></titleGroup><creators><creator creatorRole="author" xml:id="cr1" affiliationRef="#a1"><personName><givenNames>M.‐S</givenNames><familyName>Choo</familyName></personName></creator><creator creatorRole="author" xml:id="cr2" affiliationRef="#a2"><personName><givenNames>J. Z.</givenNames><familyName>Lee</familyName></personName></creator><creator creatorRole="author" xml:id="cr3" affiliationRef="#a3"><personName><givenNames>J. B.</givenNames><familyName>Lee</familyName></personName></creator><creator creatorRole="author" xml:id="cr4" affiliationRef="#a4"><personName><givenNames>Y.‐H.</givenNames><familyName>Kim</familyName></personName></creator><creator creatorRole="author" xml:id="cr5" affiliationRef="#a5"><personName><givenNames>H. C.</givenNames><familyName>Jung</familyName></personName></creator><creator creatorRole="author" xml:id="cr6" affiliationRef="#a6"><personName><givenNames>K.‐S.</givenNames><familyName>Lee</familyName></personName></creator><creator creatorRole="author" xml:id="cr7" affiliationRef="#a7"><personName><givenNames>J. C.</givenNames><familyName>Kim</familyName></personName></creator><creator creatorRole="author" xml:id="cr8" affiliationRef="#a8"><personName><givenNames>J. T.</givenNames><familyName>Seo</familyName></personName></creator><creator creatorRole="author" xml:id="cr9" affiliationRef="#a9"><personName><givenNames> J.‐S.</givenNames><familyName>Paick</familyName></personName></creator><creator creatorRole="author" xml:id="cr10" affiliationRef="#a10"><personName><givenNames>H.‐J.</givenNames><familyName>Kim</familyName></personName></creator><creator creatorRole="author" xml:id="cr11" affiliationRef="#a11"><personName><givenNames>Y. G.</givenNames><familyName>Na</familyName></personName></creator><creator creatorRole="author" xml:id="cr12" affiliationRef="#a12"><personName><givenNames>J. G.</givenNames><familyName>Lee</familyName></personName></creator></creators><affiliationGroup><affiliation xml:id="a1" countryCode="KR"><unparsedAffiliation>Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea</unparsedAffiliation></affiliation><affiliation xml:id="a2"><unparsedAffiliation>Department of Urology, College of Medicine, Pusan National University, Busan, Korea</unparsedAffiliation></affiliation><affiliation xml:id="a3" countryCode="KR"><unparsedAffiliation>Department of Urology, National Medical Center, Seoul, Korea</unparsedAffiliation></affiliation><affiliation xml:id="a4"><unparsedAffiliation>Department of Urology, Soonchunhyang University Bucheon Hospital, Bucheon, Korea</unparsedAffiliation></affiliation><affiliation xml:id="a5"><unparsedAffiliation>Department of Urology, Yeungnam University Hospital, Daegu, Korea</unparsedAffiliation></affiliation><affiliation xml:id="a6" countryCode="KR"><unparsedAffiliation>Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea</unparsedAffiliation></affiliation><affiliation xml:id="a7" countryCode="KR"><unparsedAffiliation>Department of Urology, College of Medicine, The Catholic University of Korea, Seoul, Korea</unparsedAffiliation></affiliation><affiliation xml:id="a8" countryCode="KR"><unparsedAffiliation>Department of Urology, Jeil Hospital, Kwandong University College of Medicine, Seoul, Korea</unparsedAffiliation></affiliation><affiliation xml:id="a9"><unparsedAffiliation>Department of Urology, Seoul National University College of Medicine, Seoul Korea</unparsedAffiliation></affiliation><affiliation xml:id="a10"><unparsedAffiliation>Department of Urology, Dankook University College of Medicine, Cheonan, Korea</unparsedAffiliation></affiliation><affiliation xml:id="a11"><unparsedAffiliation>Department of Urology, Chungnam National University College of Medicine, Daejeon, Korea</unparsedAffiliation></affiliation><affiliation xml:id="a12" countryCode="KR"><unparsedAffiliation>Department of Urology, College of Medicine, Korea University, Seoul, Korea</unparsedAffiliation></affiliation></affiliationGroup><abstractGroup><abstract type="main" xml:lang="en"><title type="main">Summary</title><p><b>Purpose: </b> We assessed the efficacy and safety of solifenacin compared with tolterodine for treatment of overactive bladder (OAB) in Korean patients.</p><p><b>Materials and methods: </b> The study was randomised, double‐blind, tolterodine‐controlled trial in Korea. Patients had average frequency of ≥ 8 voids per 24 h and episodes of urgency or urgency incontinence ≥ 3 during 3‐day voiding diary period. Patients were randomised to 12‐week double‐blind treatment with either tolterodine immediate release (IR) 2 mg twice daily (TOL4) or solifenacin 5 mg (SOL5) or 10 mg (SOL10) once daily. The outcome measure was mean change in daily micturition frequency, volume, daily frequency of urgency incontinence, urgency and nocturia from baseline to week 12. Quality of life was assessed using the King’s Health Questionnaire.</p><p><b>Results: </b> A total of 357 were randomised and 329 were evaluated for efficacy. All voiding parameters recorded in micturition diary improved after treatment in all three groups. Mean changes in volume voided were 19.30 ml (26.69%) in TOL4, 30.37 ml (25.89%) in SOL5 and 37.12 ml (33.36%) in SOL10 group (p = 0.03). Speed of onset of SOL10 efficacy on urgency incontinence was faster than that of SOL5 and TOL4. Quality of life improved in all three groups. Dry mouth was the most common adverse event; its incidence was the lowest in SOL5 group (7.63%, compared with 19.49% and 18.64% in SOL10 and TOL4 groups respectively).</p><p><b>Conclusions: </b> Solifenacin succinate 5 and 10 mg once daily improve OAB symptoms with acceptable tolerability levels compared with tolterodine IR 4 mg. Solifenacin 5 mg is a recommended starting dose in Korean patients with OAB.</p></abstract></abstractGroup></contentMeta><noteGroup><note xml:id="fn1" numbered="no"><p>Disclosures The authors have nothing to disclose.</p></note><note xml:id="fn2" numbered="no"><p>Trial registration Clinicaltrials.gov identifier: NCT00189800. <url href="http://clinicaltrials.gov/ct2/show/NCT00189800?term=solifenacin&rank=14">http://clinicaltrials.gov/ct2/show/NCT00189800?term=solifenacin&rank=14</url></p></note><note xml:id="fn3" numbered="no"><p>Re‐use of this article is permitted in accordance with the Creative Commons Deed, Attribution 2.5, which does not permit commercial exploitation.</p></note></noteGroup></header></component></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double‐blind, multicentre study</title></titleInfo><titleInfo type="abbreviated"><title>Solifenacin succinate in Korean patients with OAB</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Efficacy and safety of solifenacin succinate in Korean patients with overactive bladder: a randomised, prospective, double‐blind, multicentre study</title></titleInfo><name type="personal"><namePart type="given">M.‐S</namePart><namePart type="family">Choo</namePart><affiliation>Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J. Z.</namePart><namePart type="family">Lee</namePart><affiliation>Department of Urology, College of Medicine, Pusan National University, Busan, Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J. B.</namePart><namePart type="family">Lee</namePart><affiliation>Department of Urology, National Medical Center, Seoul, Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Y.‐H.</namePart><namePart type="family">Kim</namePart><affiliation>Department of Urology, Soonchunhyang University Bucheon Hospital, Bucheon, Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H. C.</namePart><namePart type="family">Jung</namePart><affiliation>Department of Urology, Yeungnam University Hospital, Daegu, Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">K.‐S.</namePart><namePart type="family">Lee</namePart><affiliation>Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J. C.</namePart><namePart type="family">Kim</namePart><affiliation>Department of Urology, College of Medicine, The Catholic University of Korea, Seoul, Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J. T.</namePart><namePart type="family">Seo</namePart><affiliation>Department of Urology, Jeil Hospital, Kwandong University College of Medicine, Seoul, Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.‐S.</namePart><namePart type="family">Paick</namePart><affiliation>Department of Urology, Seoul National University College of Medicine, Seoul Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.‐J.</namePart><namePart type="family">Kim</namePart><affiliation>Department of Urology, Dankook University College of Medicine, Cheonan, Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">Y. G.</namePart><namePart type="family">Na</namePart><affiliation>Department of Urology, Chungnam National University College of Medicine, Daejeon, Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J. G.</namePart><namePart type="family">Lee</namePart><affiliation>Department of Urology, College of Medicine, Korea University, Seoul, Korea</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="article" displayLabel="article"></genre><originInfo><publisher>Blackwell Publishing Ltd</publisher><place><placeTerm type="text">Oxford, UK</placeTerm></place><dateIssued encoding="w3cdtf">2008-11</dateIssued><edition>Paper received April 2008, accepted August 2008</edition><copyrightDate encoding="w3cdtf">2008</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType><extent unit="figures">2</extent><extent unit="tables">5</extent></physicalDescription><abstract lang="en">Purpose: We assessed the efficacy and safety of solifenacin compared with tolterodine for treatment of overactive bladder (OAB) in Korean patients. Materials and methods: The study was randomised, double‐blind, tolterodine‐controlled trial in Korea. Patients had average frequency of ≥ 8 voids per 24 h and episodes of urgency or urgency incontinence ≥ 3 during 3‐day voiding diary period. Patients were randomised to 12‐week double‐blind treatment with either tolterodine immediate release (IR) 2 mg twice daily (TOL4) or solifenacin 5 mg (SOL5) or 10 mg (SOL10) once daily. The outcome measure was mean change in daily micturition frequency, volume, daily frequency of urgency incontinence, urgency and nocturia from baseline to week 12. Quality of life was assessed using the King’s Health Questionnaire. Results: A total of 357 were randomised and 329 were evaluated for efficacy. All voiding parameters recorded in micturition diary improved after treatment in all three groups. Mean changes in volume voided were 19.30 ml (26.69%) in TOL4, 30.37 ml (25.89%) in SOL5 and 37.12 ml (33.36%) in SOL10 group (p = 0.03). Speed of onset of SOL10 efficacy on urgency incontinence was faster than that of SOL5 and TOL4. Quality of life improved in all three groups. Dry mouth was the most common adverse event; its incidence was the lowest in SOL5 group (7.63%, compared with 19.49% and 18.64% in SOL10 and TOL4 groups respectively). Conclusions: Solifenacin succinate 5 and 10 mg once daily improve OAB symptoms with acceptable tolerability levels compared with tolterodine IR 4 mg. Solifenacin 5 mg is a recommended starting dose in Korean patients with OAB.</abstract><relatedItem type="host"><titleInfo><title>International Journal of Clinical Practice</title></titleInfo><genre type="Journal">journal</genre><identifier type="ISSN">1368-5031</identifier><identifier type="eISSN">1742-1241</identifier><identifier type="DOI">10.1111/(ISSN)1742-1241</identifier><identifier type="PublisherID">IJCP</identifier><part><date>2008</date><detail type="volume"><caption>vol.</caption><number>62</number></detail><detail type="issue"><caption>no.</caption><number>11</number></detail><extent unit="pages"><start>1675</start><end>1683</end><total>9</total></extent></part></relatedItem><identifier type="istex">09A500C4C70E8A462DC009A9C386CA27B81C751D</identifier><identifier type="DOI">10.1111/j.1742-1241.2008.01898.x</identifier><identifier type="ArticleID">IJCP1898</identifier><accessCondition type="use and reproduction" contentType="copyright">© 2008 The Authors. 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