Portal de Periódicos da CAPES

Once Daily Trospium Chloride is Effective and Well Tolerated for the Treatment of Overactive Bladder: Results From a Multicenter Phase III Trial

2007; Lippincott Williams & Wilkins; Volume: 178; Issue: 3 Linguagem: Inglês

10.1016/j.juro.2007.05.058

1527-3792

David R. Staskin, Peter K. Sand, Norman R. Zinner, Roger R. Dmochowski,

Urinary Tract Infections Management

No AccessJournal of UrologyAdult urology1 Sep 2007Once Daily Trospium Chloride is Effective and Well Tolerated for the Treatment of Overactive Bladder: Results From a Multicenter Phase III Trial David Staskin, Peter Sand, Norman Zinner, Roger Dmochowski, and Trospium Study Group David StaskinDavid Staskin Department of Urology, New York Presbyterian Hospital, Weill-Cornell Medical College, New York, New York , Peter SandPeter Sand Division of Urogynecology and Reconstructive Pelvic Surgery, Evanston Continence Center, Northwestern University, Feinberg School of Medicine, Evanston, Illinois , Norman ZinnerNorman Zinner Western Clinical Research, Torrance, California , Roger DmochowskiRoger Dmochowski Department of Urology, Vanderbilt University, Nashville, Tennessee , and Trospium Study Group View All Author Informationhttps://doi.org/10.1016/j.juro.2007.05.058AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: An extended release formulation of trospium chloride was recently developed for the once daily treatment of overactive bladder. We investigated the safety, efficacy and tolerability of 60 mg trospium chloride once daily. Materials and Methods: Subjects with overactive bladder were randomized 1:1 to receive 60 mg trospium chloride once daily or placebo in this 12-week multicenter, parallel, double-blind, placebo controlled trial. Primary end points were calculated changes in diary recorded daily urinary frequency and daily urgency urinary incontinence episodes. Secondary end points were urgency severity, volume voided per void and the number of urgency voids per day. Safety was assessed by clinical examination, adverse event monitoring, clinical laboratory values and resting electrocardiograms. Results: Overall 601 subjects were prescribed trospium once daily (298) or placebo (303). Trospium once daily treatment resulted in significant improvements over placebo in all primary and key secondary efficacy outcomes at weeks 1 through 12. The most common adverse events were dry mouth (trospium 8.7% vs placebo 3%) and constipation (trospium 9.4% vs placebo 1.3%). Central nervous system adverse events were rare (headache with trospium 1.0% vs placebo 2.6%). No clinically meaningful changes in laboratory, physical examination or electrocardiogram parameters were noted. Conclusions: Trospium once daily provided significant improvements in overactive bladder symptoms (frequency, urgency urinary incontinence and urgency). Efficacy was similar to that seen previously with trospium chloride twice daily, while class effect anticholinergic adverse events occurred at comparatively low levels. Dry mouth was elicited at the lowest reported rate in the oral antimuscarinic drug class. References 1 : Multicenter phase III trial studying trospium chloride in patients with overactive bladder. Urology2006; 67: 275. Google Scholar 2 : Trospium chloride improves overactive bladder symptoms: a multicenter phase III trial. J Urol2004; 171: 2311. Link, Google Scholar 3 : Inhibitory effects of trospium chloride on cytochrome P450 enzymes in human liver microsomes. Pharmacol Toxicol1999; 85: 299. Google Scholar 4 : Clinical pharmacokinetics of trospium chloride. Clin Pharmacokinet2005; 44: 701. Google Scholar 5 Ditropan® XL (Oxybutynin Chloride) Prescribing Information. : 2004. Available at http://www.ditropanxl.com/active/janus/en_US/assets/common/company/pi/ditropanxl.pdf. Accessed January 24, 2007. Google Scholar 6 Detrol® LA (Tolterodine Tartrate) Prescribing Information. : 2005. Available at http://pfizer.com/pfizer/download/uspi_detrol_la.pdf. Accessed January 24, 2007. Google Scholar 7 VESIcare® (Solifenacin Succinate) Prescribing Information. : 2004. Available at http://www.vesicare.com/assets/vesicare_prescribing_info.pdf. Accessed January 24, 2007. Google Scholar 8 Enablex® (Darifenacin) Prescribing Information. : 2006. Available at http://www.enablex.com/content/prescribing.jsp. Accessed January 24, 2007. Google Scholar 9 : Central nervous system safety of anticholinergic drugs for the treatment of overactive bladder in the elderly. Clin Ther2005; 27: 144. Google Scholar 10 : Effect of trospium chloride on somnolence and sleepiness in patients with overactive bladder. Curr Sci2004; 5: 423. Google Scholar 11 : Intravesical instillation of human urine after oral administration of trospium, tolterodine and oxybutynin in a rat model of detrusor overactivity. BJU Int2006; 97: 400. Google Scholar 12 : Time to onset of improvement in symptoms of overactive bladder using antimuscarinic treatment. BJU Int2006; 97: 540. Google Scholar 13 : A comparison of the pharmacokinetics of once-daily trospium chloride extended-release 60 mg in fasted, fasted with antacid, and high-fat meal conditions. : 2007. Presented at winter meeting of Society for Urodynamics and Female Urology, San Diego, California, February 21–24. Google Scholar 14 : Pharmacokinetics, metabolism, and saliva output during transdermal and extended-release oral oxybutynin administration in healthy subjects. Mayo Clin Proc2003; 78: 696. Google Scholar 15 : Tolterodine once-daily: superior efficacy and tolerability in the treatment of overactive bladder. Urology2001; 57: 414. Google Scholar 16 : A validated patient reported measure of urinary urgency severity in overactive bladder for use in clinical trials. J Urol2005; 174: 604. Link, Google Scholar 17 : The overactive bladder-symptom composite score: a composite symptom score of toilet voids, urgency severity and urge urinary incontinence in patients with overactive bladder. J Urol2005; 173: 1639. Link, Google Scholar 18 : Management of overactive bladder with transdermal oxybutynin. Rev Urol2006; 8: 93. Google Scholar 19 : Multiple dose pharmacokinetics of a new once daily extended release tolterodine formulation versus immediate release tolterodine. Clin Pharmacokinet2001; 40: 227. Google Scholar 20 Sanctura® (Trospium) Prescribing Information. : 2006. Available at http://www.sanctura.com/pdf/sanctura_pi.pdf. Accessed March 9, 2007. Google Scholar © 2007 by American Urological AssociationFiguresReferencesRelatedDetailsCited byTsubouchi K, Arima H, Abe M, Matsuzaki H, Tominaga K, Fujikawa A, Gunge N, Miyazaki T, Okabe Y, Nakamura N, Matsuoka H, Okutsu S, Tada K and Haga N (2023) Effect of Pharmacotherapy for Overactive Bladder on the Incidence of and Factors Related to Urinary Tract Infection: A Systematic Review and Meta-analysisJournal of Urology, VOL. 209, NO. 4, (665-674), Online publication date: 1-Apr-2023.Griebling T (2018) Re: Brain Penetration of the OAB Drug Trospium Chloride is Not Increased in Aged MiceJournal of Urology, VOL. 190, NO. 2, (622-623), Online publication date: 1-Aug-2013. Volume 178Issue 3September 2007Page: 978-984 Advertisement Copyright & Permissions© 2007 by American Urological AssociationKeywordsoveractiveurinary incontinenceurinary bladdertrospium chlorideAcknowledgmentsStudy involvement: James Bailen, Joel Bass, Louis Bauman, David Beccia, Robert Bradford, Roy Brown, Kevin Cline, David Cook, Barrett Cowan, Arthur Donovan, Robert Edelman, Mitchell Efros, Steven Gange, Gordon Gluckman, Evan Goldfischer, Micah Harris, Richard Harris, Lester Ho, Elizabeth Houser, Maury Jayson, Terry Jones, Jed Kaminetsky, Michael Kaplan, Joel Kaufman, Ira Klimberg, Leonid Kotkin, Mitchell Kotler, Christine Laramee, Cathie LeMaster, Phillip Levin, David Lipsitz, Laura MacLean, Raj Mahey, John McGettigan, James McMurray, George Middleton, David Mitcheson, Albert Odom, Richard Pearson, William Porter, Anthony Riccotone, LuAnn Sabounjian, Bobby Sandage, Ute Schwiderski, Michael Scott, Charles Secrest, James Shipley, Jose Sotolongo, Thomas Stavoy, Mark Swierzewski and Troy Williams. The Interactive Voice Response System was administered by Kronos Communicated Data.MetricsAuthor Information David Staskin Department of Urology, New York Presbyterian Hospital, Weill-Cornell Medical College, New York, New York Financial interest and/or other relationship with Esprit Pharma, Astellas, Novartis, Watson and Pfizer. More articles by this author Peter Sand Division of Urogynecology and Reconstructive Pelvic Surgery, Evanston Continence Center, Northwestern University, Feinberg School of Medicine, Evanston, Illinois Financial interest and/or other relationship with Esprit Pharma, Indevus, Ortho, Allergan, Watson, GlaxoSmithKline, Astellas and Schwartz Pharmaceuticals. More articles by this author Norman Zinner Western Clinical Research, Torrance, California Financial interest and/or other relationship with Esprit Pharma, Indevus, Novartis, Watson, Eli Lilly, GlaxoSmithKline, Allergan, Astellas and Medtronics. More articles by this author Roger Dmochowski Department of Urology, Vanderbilt University, Nashville, Tennessee Financial interest and/or other relationship with Esprit Pharma, Indevus, Allergan, Novartis, Pfizer and Watson. More articles by this author Trospium Study Group More articles by this author Expand All Advertisement PDF downloadLoading ...