Document Detail

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.
MedLine Citation:
PMID:  9555559     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: 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. CONCLUSION: 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.
P Ekman
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  European urology     Volume:  33     ISSN:  0302-2838     ISO Abbreviation:  Eur. Urol.     Publication Date:  1998  
Date Detail:
Created Date:  1998-06-04     Completed Date:  1998-06-04     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  7512719     Medline TA:  Eur Urol     Country:  SWITZERLAND    
Other Details:
Languages:  eng     Pagination:  312-7     Citation Subset:  IM    
Department of Urology, Karolinska Hospital, Stockholm, Sweden.
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MeSH Terms
Double-Blind Method
Enzyme Inhibitors / adverse effects,  therapeutic use*
Finasteride / adverse effects,  therapeutic use*
Prostate / pathology
Prostatic Hyperplasia / drug therapy*,  pathology,  physiopathology
Testosterone 5-alpha-Reductase / antagonists & inhibitors
Reg. No./Substance:
0/Enzyme Inhibitors; 98319-26-7/Finasteride; EC 5-alpha-Reductase

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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