title: Efficacy and safety of long-term treatment with the dual 5 alpha-reductase inhibitor dutasteride in men with symptomatic benign prostatic hyperplasia.
abstract: OBJECTIVE
  Dutasteride, a dual inhibitor of Type 1 and Type 2 5 alpha-reductase, has been shown to improve disease measures in patients with symptomatic benign prostatic hyperplasia (BPH) in three randomised, placebo-controlled, large-scale, 2-year Phase III clinical studies. This paper reports the pooled results of a 2-year open-label extension of the three randomised studies assessing the long-term efficacy and safety of dutasteride.
  
  
  METHODS
  Patients randomised to dutasteride or placebo in the double-blind portion of the Phase III studies were eligible for a 2-year open-label extension, where all patients received dutasteride 0.5mg daily (dutasteride/dutasteride [D/D] group and placebo/dutasteride [P/D group]).
  
  
  RESULTS
  Significant improvements in AUA-SI score and Q(max) were observed from Month 24 to 48 in both study groups. At Month 48, patients in the D/D group had significantly greater improvements in AUA-SI score and Q(max), and significantly greater reductions in prostate volume, than those in the P/D group. Acute urinary retention and BPH-related surgery occurred in a small percentage of patients during the open-label phase. No new safety issues were noted with long-term therapy. Onset of new drug-related adverse events were reported most frequently at the start of therapy and declined over time in patients receiving dutasteride.
  
  
  CONCLUSIONS
  Long-term treatment with dutasteride results in continuing improvements in urinary symptoms and flow rate, and further reductions in TPV, in men with symptomatic BPH. The reduction in risk of AUR and BPH-related surgery, seen in the double-blind phase, was durable over 4-year treatment. Dutasteride was also well tolerated in long-term use.
authors.affiliation: 426 Department of Urology, University Hospital Nijmegen, Geert Grooteplein 10, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands. f.debruyne@uro.umcn.nl
authors.forename: Frans
authors.initials: F
authors.lastname: Debruyne
authors.forename: Jack
authors.initials: J
authors.lastname: Barkin
authors.forename: Peter
authors.initials: P
authors.lastname: van Erps
authors.forename: Mario
authors.initials: M
authors.lastname: Reis
authors.forename: Teuvo L J
authors.initials: TL
authors.lastname: Tammela
authors.forename: Claus
authors.initials: C
authors.lastname: Roehrborn
mesh_terms: D058891:5-alpha Reductase Inhibitors; D001378:Azasteroids / Q000009:adverse effects / Q000627:therapeutic use*; D013196:Dihydrotestosterone / Q000097:blood; D004311:Double-Blind Method; D000068538:Dutasteride; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D007172:Erectile Dysfunction / Q000139:chemically induced; D006177:Gynecomastia / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D011467:Prostate / Q000187:drug effects* / Q000473:pathology; D017430:Prostate-Specific Antigen / Q000097:blood; D011470:Prostatic Hyperplasia / Q000097:blood / Q000188:drug therapy*
chemical_list: D058891:5-alpha Reductase Inhibitors; D001378:Azasteroids; D004791:Enzyme Inhibitors; D013196:Dihydrotestosterone; D017430:Prostate-Specific Antigen; D000068538:Dutasteride