Maximum efficacy of finasteride is obtained within 6 months and maintained over 6 years. Follow-up of the Scandinavian Open-Extension Study. The Scandinavian Finasteride Study Group.
OBJECTIVE
To study the long-term efficacy and safety of the drug finasteride (Proscar) for benign prostatic hyperplasia and to evaluate whether an improved effect beyond 1 year was due to continuous selection of 'responders'. We also wanted to investigate whether drop-outs differed in short-term responses to those completing the trial.


METHODS
A total of 182 patients were enrolled in a double-blind randomized multicenter study with the drug finasteride. After 6 months, all patients were treated with active drug for up to 6 years. Ninety-nine of the patients (54.5%) were still in the trial at its closure.


RESULTS
Patients treated with active drug had a decrease in prostate size of around 27% at 6 months, a figure reached by the ex-placebo group at 12 months. At 6 years, both groups had a reduction in prostate size of 21% as measured from baseline. At 6 months, urinary flow had improved by a mean of 2.4 ml/s in the finasteride group and reached an improvement of 2.8 ml/s in the ex-placebo group at 12 months. At 6 years, the flow had improved by 2.2 ml/s in both groups combined as compared to baseline data. The symptom score was improved by 3.4 points in the finasteride group at 6 months and by 2.6 points in the ex-placebo group at 12 months; both values were then maintained over 6 years.


CONCLUSIONS
In responders (those completing the 6-year trial), finasteride appeared to be a safe drug which reduced the prostate size by 20-25% within 6 months, with a simultaneous 30% improvement of objective and subjective symptoms and a 2.2 ml/s improvement in urinary flow rate. The improvements were maintained for at least 6 years; however, further improvement beyond 6 months of therapy was not likely to occur.
Ekman
P
P
Department of Urology, Karolinska Hospital, Stockholm, Sweden.
D058891:5-alpha Reductase Inhibitors; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D018120:Finasteride / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D011467:Prostate / Q000473:pathology; D011470:Prostatic Hyperplasia / Q000188:drug therapy* / Q000473:pathology / Q000503:physiopathology; D014563:Urodynamics
D058891:5-alpha Reductase Inhibitors; D004791:Enzyme Inhibitors; D018120:Finasteride