1250 THE ROLE OF DUTASTERIDE IN PREVENTING BPH CLINICAL PROGRESSION IN ASYMPTOMATIC MEN WITH AN ENLARGED PROSTATE

You have accessJournal of UrologyBenign Prostatic Hyperplasia: Medical and Hormonal Therapy1 Apr 20121250 THE ROLE OF DUTASTERIDE IN PREVENTING BPH CLINICAL PROGRESSION IN ASYMPTOMATIC MEN WITH AN ENLARGED PROSTATE Paul Toren, David Margel, Girish Kulkarni, Antonio Finelli, Alexandre Zlotta, and Neil Fleshner Paul TorenPaul Toren Toronto, Canada More articles by this author , David MargelDavid Margel Toronto, Canada More articles by this author , Girish KulkarniGirish Kulkarni Toronto, Canada More articles by this author , Antonio FinelliAntonio Finelli Toronto, Canada More articles by this author , Alexandre ZlottaAlexandre Zlotta Toronto, Canada More articles by this author , and Neil FleshnerNeil Fleshner Toronto, Canada More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.1568AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Benign prostatic hypertrophy (BPH) commonly causes lower urinary tract symptoms (LUTS) among men as they age. Treatment with 5-alpha reductase inhibitors has been studied in men with moderate-severe LUTS. Although a relationship exists between prostate size and LUTS, it is not absolute and variability exists. Prostatic enlargement, however, is a risk factor for events such as acute urinary retention (AUR) and need for surgery, as well as development of clinical symptoms. Our study aims to assess the role of dutasteride in preventing clinical progression in asymptomatic or mildly symptomatic men with larger prostates using data obtained from the REDUCE study. METHODS Using data obtained from the REDUCE study, we assessed the outcomes of men with a prostate size >40 mL and baseline International Prostate Symptom Score (IPSS) <8. Men treated with any medications for BPH at time of study entry or who did not complete the end-of-study IPSS questionnaire were excluded. We compared the risk of BPH clinical progression at four years between those randomized to dutasteride versus placebo. BPH clinical progression was defined as a >4 point worsening on IPSS, AUR related to BPH, urinary tract infection, or BPH related surgery. A multivariable logistic regression assessed the effect of dutasteride on BPH clinical progression adjusting for age and baseline variables (IPSS, prostate volume, post-void residual, and peak urinary flow rate). Adverse effects were assessed. RESULTS Our study cohort consisted of 1617 men; 825 on placebo, 792 on dutasteride. A total of 464 patients (29%) experienced BPH clinical progression; 297(36%) on placebo, 167(21%) on dutasteride (P<0.001). The relative risk reduction was 44% and the absolute risk reduction was 15%, with a number needed to treat(NNT) of 7. Seventy-six patients (4.7%) had AUR: 63 on placebo and 13 on dutasteride (P<0.001). Forty-six patients had BPH related surgery: 29 on placebo and 7 on dutasteride (P<0.001). On multivariable logistic regression analysis, dutasteride significantly reduced BPH clinical progression with an odds ratio of 0.47(95% CI 0.37-0.59, P<0.001). The most common drug-related adverse effects were erectile dysfunction, at 5.1% and 9.0%(P=0.02) and decreased or no libido, at 2.3% and 6.8% (P<0.001) in the placebo and dutasteride arms, respectively. CONCLUSIONS This study is the first to explore the benefit of treating asymptomatic or mildly symptomatic men with enlarged prostates. In this cohort, dutasteride significantly decreased the incidence of BPH clinical progression over 4 years, with a NNT of 7. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e505 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Paul Toren Toronto, Canada More articles by this author David Margel Toronto, Canada More articles by this author Girish Kulkarni Toronto, Canada More articles by this author Antonio Finelli Toronto, Canada More articles by this author Alexandre Zlotta Toronto, Canada More articles by this author Neil Fleshner Toronto, Canada More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...