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Tolerability of 5 mg Solifenacin Once Daily Versus 5 mg Oxybutynin Immediate Release 3 Times Daily: Results of the VECTOR Trial

2010; Lippincott Williams & Wilkins; Volume: 183; Issue: 5 Linguagem: Inglês

10.1016/j.juro.2010.01.012

1527-3792

Sender Herschorn, Lynn Stothers, Kevin Carlson, Blair Egerdie, Jerzy B. Gajewski, Peter Pommerville, Jane Schulz, Sidney B. Radomski, Harold P. Drutz, Jack Barkin, Fran L. Paradiso‐Hardy,

Pelvic floor disorders treatments

No AccessJournal of UrologyAdult Urology1 May 2010Tolerability of 5 mg Solifenacin Once Daily Versus 5 mg Oxybutynin Immediate Release 3 Times Daily: Results of the VECTOR Trial Sender Herschorn, Lynn Stothers, Kevin Carlson, Blair Egerdie, Jerzy B. Gajewski, Peter Pommerville, Jane Schulz, Sidney Radomski, Harold Drutz, Jack Barkin, and Fran Paradiso-Hardy Sender HerschornSender Herschorn Department of Surgery/Urology, University of Toronto, Toronto, Ontario, Canada , Lynn StothersLynn Stothers University of British Columbia, Bladder Care Centre, Victoria, British Columbia, Canada , Kevin CarlsonKevin Carlson Division of Urology, University of Calgary, Calgary, Alberta, Canada , Blair EgerdieBlair Egerdie Urology Associates/Urologic Medical Research, Markham, Ontario, Canada , Jerzy B. GajewskiJerzy B. Gajewski Department of Urology, Dalhousie University, Halifax, Nova Scotia, Canada , Peter PommervillePeter Pommerville Can-Med Clinical Research, Inc., Victoria, British Columbia, Canada , Jane SchulzJane Schulz Department of Obstetrics and Gynecology, Royal Alexandra Hospital, University of Alberta, Edmonton, Alberta, Canada , Sidney RadomskiSidney Radomski Department of Surgery/Urology, University of Toronto, Toronto, Ontario, Canada , Harold DrutzHarold Drutz Department of Obstetrics and Gynecology, University of Toronto, Toronto, Ontario, Canada , Jack BarkinJack Barkin Department of Surgery, University of Toronto, Toronto, Ontario, Canada , and Fran Paradiso-HardyFran Paradiso-Hardy Kitchener and Astellas Pharma Canada, Markham, Ontario, Canada View All Author Informationhttps://doi.org/10.1016/j.juro.2010.01.012AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Although antimuscarinic treatment is indicated for overactive bladder, many patients discontinue it because of dry mouth. Of available antimuscarinics oxybutynin is associated with the highest dry mouth rate. We compared the safety and tolerability of 5 mg solifenacin vs 15 mg oxybutynin immediate release. Materials and Methods: At 12 Canadian centers a total of 132 patients with overactive bladder symptoms (greater than 1 urgency episode per 24 hours, and 8 or greater micturitions per 24 hours) were randomized to 5 mg solifenacin once daily or 5 mg oxybutynin 3 times daily for 8 weeks. The primary end point was the incidence and severity of dry mouth reported after direct questioning. Efficacy end points (3-day diary documented changes in urgency, frequency, incontinence, nocturia and voided volume), and changes on the Patient Perception of Bladder Condition scale and the Overactive Bladder Questionnaire were evaluated secondarily. Results: Of patients on solifenacin vs oxybutynin immediate release 35% vs 83% reported dry mouth (p <0.0001). Of patients reporting dry mouth severity was graded moderate by 13% and 42% of those on solifenacin and oxybutynin immediate release, and severe by 13% and 28%, respectively (p = 0.001). Patients in each group showed improvements in efficacy end points, and Patient Perception of Bladder Condition scale and Overactive Bladder Questionnaire scores from baseline to treatment end. Conclusions: Significantly fewer patients on 5 mg solifenacin once daily reported dry mouth vs those receiving 5 mg oxybutynin immediate release 3 times daily. Significantly fewer patients on solifenacin reported moderate/severe dry mouth. Significantly fewer patients on solifenacin withdrew from study due to dry mouth and there were significantly fewer overall adverse events. Solifenacin and oxybutynin immediate release were efficacious in decreasing efficacy end points, and improved Patient Perception of Bladder Condition scale and Overactive Bladder Questionnaire results from baseline to treatment end. 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Volume 183Issue 5May 2010Page: 1892-1898 Advertisement Copyright & Permissions© 2010 by American Urological Association Education and Research, Inc.KeywordsCanadaquinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinateoxybutyninoveractivexerostomiaurinary bladderAcknowledgmentsSt. Clare Chung, Ann Leung and Joon Foo, SciAn Services, Inc. provided the statistical analysis. Fanny Lee, Principal Clinical Research Associate, Astellas Canada managed the study. Sue Cooper, Envision Scientific Solutions assisted with the manuscript. SciAn Services, Inc. provided the patient computerized randomization list.MetricsAuthor Information Sender Herschorn Department of Surgery/Urology, University of Toronto, Toronto, Ontario, Canada Financial interest and/or other relationship with Astellas, Pfizer, Allergan, American Medical Systems, Johnson & Johnson and Coloplast. More articles by this author Lynn Stothers University of British Columbia, Bladder Care Centre, Victoria, British Columbia, Canada Financial interest and/or other relationship with Astellas Canada, Merck, Urodynamix, Allergan, UBC. More articles by this author Kevin Carlson Division of Urology, University of Calgary, Calgary, Alberta, Canada Financial interest and/or other relationship with Astellas Canada, Pfizer Canada, GlaxoSmithKline, American Medical Systems, BR Capital Inc. and Health Education United Partnership Inc. More articles by this author Blair Egerdie Urology Associates/Urologic Medical Research, Markham, Ontario, Canada Financial interest and/or other relationship with Astellas Canada, Amgen, Bayer, Protox Therapeutics and Pfizer. More articles by this author Jerzy B. Gajewski Department of Urology, Dalhousie University, Halifax, Nova Scotia, Canada Financial interest and/or other relationship with Astellas Canada, Allergan, Pfizer, Sanofi-Aventis, Johnson & Johnson and Medtronic. More articles by this author Peter Pommerville Can-Med Clinical Research, Inc., Victoria, British Columbia, Canada Financial interest and/or other relationship with Astellas Canada, Aeterna Zentralis, American Medical Systems, Amgen, AstraZeneca, Dendreon, Eli Lilly, Ferring, Pfizer, Protox Therapeutics, Spectrum, Uromedica, Bioniche Inc., Sanofi-Aventis, GlaxoSmithKline, Schering Plough, Amgen and Abbott. More articles by this author Jane Schulz Department of Obstetrics and Gynecology, Royal Alexandra Hospital, University of Alberta, Edmonton, Alberta, Canada Financial interest and/or other relationship with Astellas, Gynecare, Pfizer and Triton. More articles by this author Sidney Radomski Department of Surgery/Urology, University of Toronto, Toronto, Ontario, Canada Financial interest and/or other relationship with Astellas Canada, Pfizer, Bayer and Lilly. More articles by this author Harold Drutz Department of Obstetrics and Gynecology, University of Toronto, Toronto, Ontario, Canada Financial interest and/or other relationship with Astellas, Lilly, Pfizer, Calladion, Gynecare, Triton and Watson. More articles by this author Jack Barkin Department of Surgery, University of Toronto, Toronto, Ontario, Canada Financial interest and/or other relationship with Astellas, GlaxoSmithKline, Merck, AstraZeneca and Pfizer. More articles by this author Fran Paradiso-Hardy Kitchener and Astellas Pharma Canada, Markham, Ontario, Canada Financial interest and/or other relationship with Astellas Pharma Canada. More articles by this author Expand All Advertisement PDF downloadLoading ...