title: Efficacy of finasteride is maintained in patients with benign prostatic hyperplasia treated for 5 years. The North American Finasteride Study Group.
abstract: OBJECTIVE
  The purpose of this open-label study extension was to assess the long-term safety and efficacy of finasteride in the treatment of men with benign prostatic hyperplasia (BPH).
  
  
  METHODS
  A Phase III North American BPH trial originally enrolled 895 men, 297 of whom were randomized to receive finasteride 5 mg. An enlarged prostate gland by digital rectal examination, symptoms of urinary obstruction, and a maximal urinary flow rate of less than 15 mL/s were required for entry. Patients who completed the initial 12-month, double-blind, placebo-controlled study were invited to participate in an open-label extension for 4 additional years.
  
  
  RESULTS
  Of the 297 patients initially randomized to receive finasteride 5 mg, 259 completed 12 months in the double-blind period and 186 completed 48 months of open-label therapy. Prostate volume reached a nadir of -24.6% at month 24, and the effect was maintained through month 60. Compared with baseline values, month 60 prostate volume was decreased by 22.7% (P<0.001), the quasi-American Urological Association symptom score was decreased by 4.3 points, and maximal urinary flow was increased by 2.3 mL/s (P<0.001) on average. Finasteride was well tolerated, with no significant increase in the prevalence of sexual adverse events over time.
  
  
  CONCLUSIONS
  Patients treated with finasteride 5 mg maintained an initial decrease in prostate volume and improvement in symptom score and maximal urinary flow rate over 5 years.
authors: Tampa Bay Urological Institute, Seminole, Florida, USA.
authors: P B
authors: PB
authors: Hudson
authors: R
authors: R
authors: Boake
authors: J
authors: J
authors: Trachtenberg
authors: N A
authors: NA
authors: Romas
authors: S
authors: S
authors: Rosenblatt
authors: P
authors: P
authors: Narayan
authors: J
authors: J
authors: Geller
authors: M M
authors: MM
authors: Lieber
authors: M
authors: M
authors: Elhilali
authors: R
authors: R
authors: Norman
authors: L
authors: L
authors: Patterson
authors: J P
authors: JP
authors: Perreault
authors: G H
authors: GH
authors: Malek
authors: R C
authors: RC
authors: Bruskewitz
authors: J B
authors: JB
authors: Roy
authors: A
authors: A
authors: Ko
authors: C A
authors: CA
authors: Jacobsen
authors: E
authors: E
authors: Stoner
mesh_terms: D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D018120:Finasteride / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D010352:Patient Dropouts; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D013997:Time Factors
chemical_list: D004791:Enzyme Inhibitors; D018120:Finasteride