1385 EFFECTS OF FINASTERIDE AND TADALAFIL COMBINATION THERAPY ON LOWER URINARY TRACT SYMPTOMS AND ERECTILE FUNCTION IN MEN WITH PROSTATIC ENLARGEMENT: A RANDOMIZED, PLACEBO-CONTROLLED 6-MONTH STUDY

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You have accessJournal of UrologyBenign Prostatic Hyperlasia: Medical and Hormonal Therapy1 Apr 20131385 EFFECTS OF FINASTERIDE AND TADALAFIL COMBINATION THERAPY ON LOWER URINARY TRACT SYMPTOMS AND ERECTILE FUNCTION IN MEN WITH PROSTATIC ENLARGEMENT: A RANDOMIZED, PLACEBO-CONTROLLED 6-MONTH STUDY Sidney Glina, Claus Roehrborn, Ketan Kapadia, Alexey Plekhanov, Adil Esen, Sebastian Sorsaburu, Carsten Henneges, Hartwig Buettner, and Lars Viktrup Sidney GlinaSidney Glina Sao Paolo, Brazil More articles by this author , Claus RoehrbornClaus Roehrborn Dallas, TX More articles by this author , Ketan KapadiaKetan Kapadia St. Petersburg, FL More articles by this author , Alexey PlekhanovAlexey Plekhanov St Petersburg, Russian Federation More articles by this author , Adil EsenAdil Esen Konak, Turkey More articles by this author , Sebastian SorsaburuSebastian Sorsaburu Indianapolis, IN More articles by this author , Carsten HennegesCarsten Henneges Bad Homburg, Germany More articles by this author , Hartwig BuettnerHartwig Buettner Bad Homburg, Germany More articles by this author , and Lars ViktrupLars Viktrup Indianapolis, IN More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2739AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The 5-alpha reductase inhibitor (5-ARI) finasteride is indicated for symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. 5-ARIs may reduce long-term risk of urinary retention but increase risk of sexual dysfunction. Tadalafil, a phosphodiesterase 5 inhibitor, is indicated for erectile dysfunction (ED) and for signs and symptoms of BPH (lower urinary tract symptoms suggestive of BPH, LUTS/BPH). Effects of once daily tadalafil 5 mg or placebo coadministered with finasteride 5 mg were assessed over 26 weeks. METHODS Men ≥45 years old and naïve to 5-ARIs, with International Prostate Symptom Score (IPSS) ≥13, Qmax ≥4 to ≤15 mL/sec and prostate volume ≥30mL, were randomized to finasteride/placebo (N=350) or finasteride/tadalafil (N=346) following a 4-week placebo run-in. Efficacy measures were assessed using mixed models for repeated measures. RESULTS Baseline mean (SD) age was 63.7 (7.7) years, mean prostate volume was 49.4 (20.4) mL, and mean prostate-specific antigen was 2.4 (2.0) ng/ml. IPSS improved significantly (p<0.05) at 4, 12 (primary endpoint, trt. diff. -1.41, p=0.001), and 26 weeks for finasteride/tadalafil vs. finasteride/placebo. In sexually active men, the International Index of Erectile Function-Erectile Function (IIEF-EF) domain score improved significantly with finasteride/tadalafil vs. finasteride/placebo at each visit in both men with and without (post hoc analysis) baseline ED (Figure). Most adverse events (AEs) with finasteride/tadalafil were mild or moderate in severity, and there were few discontinuations due to AEs. In the finasteride/placebo and finasteride/tadalafil treatment groups, 5 vs. 0 patients reported decrease/loss of libido and 5 vs. 1 patient reported ED, respectively. CONCLUSIONS Urinary symptoms were reduced significantly more at each study visit with finasteride/tadalafil vs. finasteride/placebo. In sexually active men, erectile function improved significantly with tadalafil in men with ED and those without ED prior to starting finasteride. Finasteride/tadalafil was generally well tolerated, with fewer events of reduced libido or ED vs. finasteride/placebo. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e566-e567 Peer Review Report Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Sidney Glina Sao Paolo, Brazil More articles by this author Claus Roehrborn Dallas, TX More articles by this author Ketan Kapadia St. Petersburg, FL More articles by this author Alexey Plekhanov St Petersburg, Russian Federation More articles by this author Adil Esen Konak, Turkey More articles by this author Sebastian Sorsaburu Indianapolis, IN More articles by this author Carsten Henneges Bad Homburg, Germany More articles by this author Hartwig Buettner Bad Homburg, Germany More articles by this author Lars Viktrup Indianapolis, IN More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...