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Getur fínasteríð hamið aukningu einkenna góðkynja blöðruhálskirtilsstækkunar? : tveggja ára lyfleysu samanburðarrannsókn

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Authors
Guðmundur Vikar Einarsson
Andersen, Jens Thorup
Þorsteinn Gíslason
Wolf, Hans
Ekman, Peter
Beisland, Hans Olav
Johansson, Jan-Erik
Kontturi, Matti
Lehtonen, Tímo
Tveter, Kjell
Issue Date
1996-12-01

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Can finasteride reverse the progress of benign prostatic hyperplasia? A two-year placebo-controlled study
Citation
Læknablaðið 1996, 82(12):859-66
Abstract
Objective: To study if placebo-induced improvement in men with symptomatic benign prostatic hyperplasia (BPH) is maintained over two years, and to study the efficacy and safety from intervention with finasteride 5 mg for 24 months. Methods: This was a multicenter, double-blind, placeba-controlled study involving 707 patients with moderate symptoms of BPH enrolled at 59 centers in five Scandinavian countries. Following enrollment and a four-week single-blind placebo run-in period, patients were randomized to receive finasteride 5 mg once daily or placebo for 24 months. Urinary symptoms, urinary flow rate, prostate volume, postvoiding residual urinary volume, and serum concentrations of prostate-specific antigen together with laboratory safety parameters were measured at entry and at months 12 and 24. Interim physical and laboratory examinations were performed when indicated clinically. Results: In finasteride-treated patients the total symptom score improved throughout the study, with a significant difference between the two groups at 24 months (p<0.01) whereas in placebo-treated patients, there was an initial improvement in the symptom score but no change from baseline at 24 months. The maximum urinary flow rate decreased in the placebo group, but improved in the finasteride group, resulting in a between-group difference of 1.8 mL/s at 24 months (p<0.01). The mean change in prostate volume was +12% in the placebo group versus —19% in the finasteride-treated group (p<0.01). Finasteride was generally well tolerated throughout the two-year study period. Conclusions: The efficacy of therapy with finasteride 5 mg in improving both symptoms and maximum urinary flow rate and reducing prostate volume has been shown to be maintained during 24 months while patients receiving placebo experienced a return to baseline or deterioration of these parameters during the study. These results demonstrate that finasteride can reverse the natural progression of BPH.
Markmið: Leitað var svara við því hvort bati haldist hjá karlmönnum með einkenni vegna góðkynja stækkunar á blöðruhálskirtli (benign prostatic hyperplasia, BPH) sem fá lyfleysu? Könnuð voru áhrif og öryggisþættir með notkun 5 mg af fínasteríði í 24 mánuði. Aðferðir: Rannsóknin var tvíblind samanburðarrannsókn með lyfleysu á 707 sjúklingum með miðlungseinkenni vegna góðkynja stækkunar á blöðruhálskirtli og fór rannsóknin fram á 59 stöðum á Norðurlöndunum. Sjúklingar sem uppfylltu skilyrðin og höfðu verið á eins mánaðar blindu lyfleysutímabili voru samkvæmt slembiúrtaki settir á 5 mg af fínasteríði einu sinni á dag eða lyfleysu í 24 mánuði. Þvagvegaeinkenni, þvagflæði, stærð blöðruhálskirtils, eftirhreytuþvag og sértækt blöðruhálskirt-ilsmótefni í sermi (prostatic specific antigen, PSA) ásamt öðrum öryggismælingum var mælt í byrjun og í lok 12. og 24. mánaðar. Þess á milli voru sjúklingar athugaðir og blóð- og þvag-prufur teknar þegar ástæða þótti til vegna einkenna. Niðurstöður: Einkennaskorið (symptom score) batnaði meðan á rannsókn stóð hjá sjúklingum sem fengu fínasteríð, auk þess sem marktækur munur reyndist milli hópanna tveggja í lok 24. mánaðar (p<0,01). Einkennaskor sjúklinga í lyfleysuhópnum batnaði í byrjun en engin breyting frá grunnlínu reyndist hjá þeim á 24. mánuði. Hámarksþvagflæði minnkaði í lyfleysuhópnum en lagaðist í fínasteríðhópnum þar sem munurinn á milli hópanna var 1,8 ml á sekúndu í lok 24. mánaðar (p<0,01). Meðalbreyting á rúmmáli blöðruhálskirtils var +12% í lyfleysuhópnum en -19% í fínasteríðhópnum (p<0,01). Fínasteríð þoldist yfirleitt vel þau tvö ár sem rannsóknin stóð. Ályktun: Það sýnir sig að bati í einkennum, hámarksflæði og minna rúmmál blöðruhálskirtils við fínasteríðmeðferð helst í 24 mánuði, en ástand sjúklinga sem fá lyfleysu heist óbreytt og versnar jafnvel hvað þessa þætti varðar. Niðurstöðurnar sýna að fínasteríð getur snúið við eðlilegri þróun góðkynja stækkunar á blöðruhálskirtli.
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