title: Long-term 6-year experience with finasteride in patients with benign prostatic hyperplasia.
abstract: OBJECTIVE
  To summarize the 6-year clinical trial data with finasteride. Benign prostatic hyperplasia is a chronic and progressive disease and therefore assessment of long-term safety and efficacy is important.
  
  
  METHODS
  The North American and International Phase III Finasteride trials enrolled symptomatic men with enlarged prostate glands. The initial 1-year placebo-controlled study was followed by a 5-year open-label extension. In total, 6-year finasteride data were available in 487 patients originally randomized to finasteride, and 5-year data were available on 238 patients originally randomized to placebo.
  
  
  RESULTS
  After 6 years of treatment with finasteride 5 mg, the mean quasi-American Urological Association Symptom Score improved by 4.0 points, the median prostate volume decreased by 24%, and the mean maximal urinary flow rate increased by 2.9 mL/s (P <0.001 for all parameters). Long-term finasteride treatment was well tolerated, with a low incidence of drug-related sexual adverse events occurring during the first year and even fewer occurrences during the 5-year open extension.
  
  
  CONCLUSIONS
  Treatment with finasteride leads to durable improvement in urinary tract symptoms, flow rate, and prostate volume, with no increase in the prevalence of drug-related adverse events over time.
authors.affiliation: Department of Urology, Saint Luke's-Roosevelt Hospital Center, New York, NY 10019, USA.
authors.forename: Franklin C
authors.initials: FC
authors.lastname: Lowe
authors.forename: John D
authors.initials: JD
authors.lastname: McConnell
authors.forename: Perry B
authors.initials: PB
authors.lastname: Hudson
authors.forename: Nicholas A
authors.initials: NA
authors.lastname: Romas
authors.forename: Rex
authors.initials: R
authors.lastname: Boake
authors.forename: Michael
authors.initials: M
authors.lastname: Lieber
authors.forename: Mostafa
authors.initials: M
authors.lastname: Elhilali
authors.forename: Jack
authors.initials: J
authors.lastname: Geller
authors.forename: Juliane
authors.initials: J
authors.lastname: Imperto-McGinely
authors.forename: Gerald L
authors.initials: GL
authors.lastname: Andriole
authors.forename: Reginald C
authors.initials: RC
authors.lastname: Bruskewitz
authors.forename: Patrick C
authors.initials: PC
authors.lastname: Walsh
authors.forename: Georg
authors.initials: G
authors.lastname: Bartsch
authors.forename: John N
authors.initials: JN
authors.lastname: Nacey
authors.forename: Sukrut
authors.initials: S
authors.lastname: Shah
authors.forename: Frances
authors.initials: F
authors.lastname: Pappas
authors.forename: Amy
authors.initials: A
authors.lastname: Ko
authors.forename: Thomas
authors.initials: T
authors.lastname: Cook
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Stoner
authors.forename: Joanne
authors.initials: J
authors.lastname: Waldstreicher
mesh_terms: D058891:5-alpha Reductase Inhibitors; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D007172:Erectile Dysfunction / Q000139:chemically induced; D018120:Finasteride / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011467:Prostate / Q000473:pathology; D011470:Prostatic Hyperplasia / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology; D020018:Sexual Dysfunctions, Psychological / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: D058891:5-alpha Reductase Inhibitors; D004791:Enzyme Inhibitors; D010919:Placebos; D018120:Finasteride