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Tadalafil Relieves Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

2007; Lippincott Williams & Wilkins; Volume: 177; Issue: 4 Linguagem: Inglês

10.1016/j.juro.2006.11.037

1527-3792

Kevin T. McVary, Claus G. Roehrborn, Jed Kaminetsky, Stephen M. Auerbach, Barton Wachs, Jay M. Young, Anne Esler, Gregory D. Sides, Béla Dénes,

Sexual function and dysfunction studies

No AccessJournal of UrologyAdult urology1 Apr 2007Tadalafil Relieves Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasiais accompanied byUrodynamic Effects of a Novel EP1 Receptor Antagonist in Normal Rats and Rats With Bladder Outlet Obstruction Kevin T. McVary, Claus G. Roehrborn, Jed C. Kaminetsky, Stephen M. Auerbach, Barton Wachs, Jay M. Young, Anne Esler, Gregory D. Sides, and Bela S. Denes Kevin T. McVaryKevin T. McVary Department of Urology, Northwestern University Medical School, Chicago, Illinois , Claus G. RoehrbornClaus G. Roehrborn Department of Urology, University of Texas Southwestern Medical Center, Dallas, Texas , Jed C. KaminetskyJed C. Kaminetsky University Urology Associates, New York, New York , Stephen M. AuerbachStephen M. Auerbach California Professional Research, Newport Beach , Barton WachsBarton Wachs Atlantic Urology Medical Group, Laguna Woods, California , Jay M. YoungJay M. Young Long Beach and South Orange County Medical Research Center, Laguna Woods, California , Anne EslerAnne Esler ICOS Corp., Bothell, Washington , Gregory D. SidesGregory D. Sides Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana , and Bela S. DenesBela S. Denes ICOS Corp., Bothell, Washington View All Author Informationhttps://doi.org/10.1016/j.juro.2006.11.037AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We assessed the efficacy and safety of tadalafil dosed once daily for lower urinary tract symptoms secondary to benign prostatic hyperplasia. Materials and Methods: Following a 4-week, single-blind, placebo run-in 281 men were randomly assigned (1:1) to 5 mg tadalafil for 6 weeks, followed by dose escalation to 20 mg for 6 weeks or 12 weeks of placebo. Results: Tadalafil significantly improved the mean change from baseline in International Prostate Symptom Score at 6 weeks (5 mg tadalafil −2.8 vs placebo −1.2) and at 12 weeks (5/20 mg tadalafil −3.8 vs placebo −1.7). Larger changes were observed with inclusion of the placebo run-in at 12 weeks (5/20 mg tadalafil −7.1 vs placebo −4.5). Significant improvements were also seen in the International Prostate Symptom Score irritative and obstructive domains, the International Prostate Symptom Score quality of life index, a question about urinary symptom improvement and the Benign Prostatic Hyperplasia Impact Index (significant at 12 weeks) vs placebo. International Prostate Symptom Score and International Index of Erectile Function erectile function domain scores significantly improved in the 56% of men with lower urinary tract symptoms/benign prostatic hyperplasia who were sexually active and had erectile dysfunction. Changes in uroflowmetry parameters were similar in the placebo and tadalafil groups. Commonly reported (2% or greater) treatment emergent adverse events were "erection increased," dyspepsia, back pain, headache, nasopharyngitis and upper respiratory tract infection (each 5.1% or less). No change in post-void residual volume was seen with tadalafil treatment. Conclusions: Tadalafil once daily was well tolerated and demonstrated clinically meaningful and statistically significant symptomatic improvement for lower urinary tract symptoms/benign prostatic hyperplasia. Tadalafil also improved erectile function in men with lower urinary tract symptoms and erectile dysfunction. References 1 : Urologic diseases in America project: benign prostatic hyperplasia. J Urol2005; 173: 1256. Link, Google Scholar 2 : Lower urinary tract symptoms and male sexual dysfunction: the Multinational Survey of the Aging Male (MSAM-7). Eur Urol2003; 44: 637. 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Google Scholar © 2007 by American Urological AssociationFiguresReferencesRelatedDetailsCited byLerner L, McVary K, Barry M, Bixler B, Dahm P, Das A, Gandhi M, Kaplan S, Kohler T, Martin L, Parsons J, Roehrborn C, Stoffel J, Welliver C and Wilt T (2021) Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA GUIDELINE PART I—Initial Work-up and Medical ManagementJournal of Urology, VOL. 206, NO. 4, (806-817), Online publication date: 1-Oct-2021.Roehrborn C, Chapple C, Oelke M, Cox D, Esler A and Viktrup L (2013) Effects of Tadalafil Once Daily on Maximum Urinary Flow Rate in Men with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic HyperplasiaJournal of Urology, VOL. 191, NO. 4, (1045-1050), Online publication date: 1-Apr-2014.Dmochowski R (2013) Elucidation of Phosphodiesterase Type 5 Inhibitor Mechanism of ActionJournal of Urology, VOL. 190, NO. 4, (1161-1162), Online publication date: 1-Oct-2013.Füllhase C, Hennenberg M, Giese A, Schmidt M, Strittmatter F, Soler R, Gratzke C, Andersson K and Stief C (2013) Presence of Phosphodiesterase Type 5 in the Spinal Cord and its Involvement in Bladder Outflow Obstruction Related Bladder OveractivityJournal of Urology, VOL. 190, NO. 4, (1430-1435), Online publication date: 1-Oct-2013.Chung J, Kang D, Oh C, Chung J, Lee K, Kim T, Moon K, Lee W, Cho J and Lee S (2012) Safety and Efficacy of Once Daily Administration of 50 mg Mirodenafil in Patients with Erectile Dysfunction: a Multicenter, Double-Blind, Placebo Controlled TrialJournal of Urology, VOL. 189, NO. 3, (1006-1013), Online publication date: 1-Mar-2013.Nomiya M, Burmeister D, Sawada N, Campeau L, Zarifpour M, Keys T, Peyton C, Yamaguchi O and Andersson K (2012) Prophylactic Effect of Tadalafil on Bladder Function in a Rat Model of Chronic Bladder IschemiaJournal of Urology, VOL. 189, NO. 2, (754-761), Online publication date: 1-Feb-2013.Kupelian V, McVary K, Kaplan S, Hall S, Link C, Aiyer L, Mollon P, Tamimi N, Rosen R and McKinlay J (2018) Association of Lower Urinary Tract Symptoms and the Metabolic Syndrome: Results From the Boston Area Community Health SurveyJournal of Urology, VOL. 189, NO. 1S, (S107-S116), Online publication date: 1-Jan-2013.Dmochowski R, Roehrborn C, Klise S, Xu L, Kaminetsky J and Kraus S (2018) Urodynamic Effects of Once Daily Tadalafil in Men With Lower Urinary Tract Symptoms Secondary to Clinical Benign Prostatic Hyperplasia: A Randomized, Placebo Controlled 12-Week Clinical TrialJournal of Urology, VOL. 189, NO. 1S, (S135-S140), Online publication date: 1-Jan-2013.Dmochowski R, Roehrborn C, Klise S, Xu L, Kaminetsky J and Kraus S (2010) Urodynamic Effects of Once Daily Tadalafil in Men With Lower Urinary Tract Symptoms Secondary to Clinical Benign Prostatic Hyperplasia: A Randomized, Placebo Controlled 12-Week Clinical TrialJournal of Urology, VOL. 183, NO. 3, (1092-1097), Online publication date: 1-Mar-2010.Kupelian V, McVary K, Kaplan S, Hall S, Link C, Aiyer L, Mollon P, Tamimi N, Rosen R and McKinlay J (2009) Association of Lower Urinary Tract Symptoms and the Metabolic Syndrome: Results From the Boston Area Community Health SurveyJournal of Urology, VOL. 182, NO. 2, (616-625), Online publication date: 1-Aug-2009.Roehrborn C, McVary K, Elion-Mboussa A and Viktrup L (2008) Tadalafil Administered Once Daily for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Dose Finding StudyJournal of Urology, VOL. 180, NO. 4, (1228-1234), Online publication date: 1-Oct-2008.Andersson K (2008) How Many Drugs for LUTS Due to BPH are Too Many?Journal of Urology, VOL. 180, NO. 3, (811-812), Online publication date: 1-Sep-2008.Ng C, Wong A, Cheng C, Chan E, Wong H and Hou S (2008) Effect of Vardenafil on Blood Pressure Profile of Patients With Erectile Dysfunction Concomitantly Treated With Doxazosin Gastrointestinal Therapeutic System for Benign Prostatic HyperplasiaJournal of Urology, VOL. 180, NO. 3, (1042-1046), Online publication date: 1-Sep-2008.Giuliano F (2007) Editorial CommentJournal of Urology, VOL. 178, NO. 5, (2044-2044), Online publication date: 1-Nov-2007. (2007) Reply by AuthorsJournal of Urology, VOL. 178, NO. 3, (1122-1123), Online publication date: 1-Sep-2007.Related articlesJournal of Urology9 Nov 2018Urodynamic Effects of a Novel EP1 Receptor Antagonist in Normal Rats and Rats With Bladder Outlet Obstruction Volume 177Issue 4April 2007Page: 1401-1407 Advertisement Copyright & Permissions© 2007 by American Urological AssociationKeywordsurination disorderstadalafilprostatic hyperplasiaimpotenceprostateAcknowledgmentsKate Loughney, ICOS Corp. provided medical writing assistance and David Goodkin, ICOS Corp. reviewed the manuscript.MetricsAuthor Information Kevin T. McVary Department of Urology, Northwestern University Medical School, Chicago, Illinois Financial interest and/or other relationship with Pfizer, Lilly ICOS, GlaxoSmithKline, Boston Scientific, Merck and Sanofi. More articles by this author Claus G. Roehrborn Department of Urology, University of Texas Southwestern Medical Center, Dallas, Texas Financial interest and/or other relationship with Lilly ICOS. More articles by this author Jed C. Kaminetsky University Urology Associates, New York, New York Financial interest and/or other relationship with Lilly ICOS, Pfizer, GlaxoSmithKline, Boehringer-Ingelheim, Astellas and Auxilium. More articles by this author Stephen M. Auerbach California Professional Research, Newport Beach Financial interest and/or other relationship with Lilly ICOS, Indevus, Pfizer, GlaxoSmithKline, Novartis and Yamanouchi. More articles by this author Barton Wachs Atlantic Urology Medical Group, Laguna Woods, California Financial interest and/or other relationship with Pfizer, ICOS, Bayer and Schering. More articles by this author Jay M. Young Long Beach and South Orange County Medical Research Center, Laguna Woods, California Financial interest and/or other relationship with Pfizer, Lilly ICOS, GlaxoSmithKline and Palatin. More articles by this author Anne Esler ICOS Corp., Bothell, Washington More articles by this author Gregory D. Sides Lilly Research Laboratories, Eli Lilly and Co., Indianapolis, Indiana Financial interest and/or other relationship with Eli Lilly. More articles by this author Bela S. Denes ICOS Corp., Bothell, Washington More articles by this author Expand All Advertisement PDF downloadLoading ...