title: Dutasteride is associated with reduced risk of transrectal prostate biopsy-associated urinary tract infection and related hospitalizations.
abstract: OBJECTIVE
  To evaluate whether the use of dutasteride is associated with a lower risk of transrectal prostate biopsy-associated urinary tract infection (TPBA-UTI) among men in the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) study.
  
  
  METHODS
  Retrospective analysis of 6045 men undergoing 2-year repeat prostate biopsy in REDUCE. Participants were randomized to receive dutasteride 0.5 mg or placebo daily. TPBA-UTI was defined as the presence of urinary symptoms and the prescription of antibiotics by the treating physician within 30 days after biopsy. Severe TPBA-UTI was defined as TPBA-UTI requiring hospitalization. Comparison of TPBA-UTI between treatment arms was done using Chi-square test and logistic regression adjusting for participant characteristics.
  
  
  RESULTS
  Of the subjects included in the study, 3067 (50.7%) were randomized to the placebo arm and 2978 (49.3%) to the dutasteride arm. A total 51 (0.8%) men had TPBA-UTI, including 38 (1.2%) in the placebo arm and 13 (0.4%) in the dutasteride arm (univariable relative risk [RR] = 0.35, P = 0.001; multivariable odds ratio [OR] = 0.34, P = 0.003). The number needed to treat (NNT) to prevent one TPBA-UTI was 125 subjects. Of these, 14 (28%) had severe TPBA-UTI, including 12 (0.4%) in the placebo arm and only 2 (0.07%) in the dutasteride arm (univariable RR = 0.17, P = 0.021; multivariable OR = 0.17, P = 0.031). The NNT to prevent one severe TPBA-UTI was 309 subjects.
  
  
  CONCLUSIONS
  Among men undergoing a 2-year repeat prostate biopsy, the use of dutasteride for 2 years was associated with a reduced the risk of overall and severe TBPA-UTI. CLINICALTRIALS.
  NCT00056407.
authors.affiliation: Department of Urology, University of Illinois at Chicago, 820 S Wood Street, CSN Suite 515, Chicago, IL, 60612, USA. moreira@uic.edu.
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Moreira
authors.affiliation: Division of Urologic Surgery, Department of Surgery, Washington University School of Medicine, St. Louis, MO, USA.
authors.forename: Gerald L
authors.initials: GL
authors.lastname: Andriole
authors.affiliation: Department of Urology, Queen's University, Kingston, ON, Canada.
authors.forename: J Curtis
authors.initials: JC
authors.lastname: Nickel
authors.affiliation: Department of Urology, University of Texas Southwestern Medical Center, Dallas, TX, USA.
authors.forename: Claus G
authors.initials: CG
authors.lastname: Roehrborn
authors.affiliation: GlaxoSmithKline Inc., Global R&D, King of Prussia, PA, USA.
authors.forename: Ramiro
authors.initials: R
authors.lastname: Castro-Santamaria
authors.affiliation: Division of Urology, Department of Surgery, Cedars Sinai Medical Center, Los Angeles, CA, USA.
authors.forename: Stephen J
authors.initials: SJ
authors.lastname: Freedland
mesh_terms: D058891:5-alpha Reductase Inhibitors / Q000008:administration & dosage; D000368:Aged; D001706:Biopsy / Q000009:adverse effects* / Q000379:methods; D018890:Chemoprevention / Q000379:methods; D000068538:Dutasteride / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011467:Prostate / Q000473:pathology*; D011470:Prostatic Hyperplasia / Q000473:pathology; D011471:Prostatic Neoplasms / Q000473:pathology*; D020379:Risk Adjustment; D016896:Treatment Outcome; D014552:Urinary Tract Infections / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control
chemical_list: D058891:5-alpha Reductase Inhibitors; D000068538:Dutasteride
keywords: 5-Alpha-reductase inhibitors; Biopsy; Double-blind method; Dutasteride; Humans; Male; Middle aged; Urinary tract infection