| 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. | |
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MedLine Citation:
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PMID: 9555559 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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P Ekman |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial |
Journal Detail:
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Title: European urology Volume: 33 ISSN: 0302-2838 ISO Abbreviation: Eur. Urol. Publication Date: 1998 |
Date Detail:
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Created Date: 1998-06-04 Completed Date: 1998-06-04 Revised Date: 2004-11-17 |
Medline Journal Info:
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Nlm Unique ID: 7512719 Medline TA: Eur Urol Country: SWITZERLAND |
Other Details:
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Languages: eng Pagination: 312-7 Citation Subset: IM |
Affiliation:
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Department of Urology, Karolinska Hospital, Stockholm, Sweden. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Double-Blind Method Enzyme Inhibitors / adverse effects, therapeutic use* Finasteride / adverse effects, therapeutic use* Humans Male Prostate / pathology Prostatic Hyperplasia / drug therapy*, pathology, physiopathology Testosterone 5-alpha-Reductase / antagonists & inhibitors Urodynamics |
| Chemical | |
Reg. No./Substance:
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0/Enzyme Inhibitors; 98319-26-7/Finasteride; EC 1.3.99.5/Testosterone 5-alpha-Reductase |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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