Læknablaðið - 15.12.1996, Page 35

LÆKNABLAÐIÐ 1996; 82
859
Getur fínasteríð hamið aukningu
einkenna góðkynja blöðruhálskirtils-
stækkunar?
Tveggja ára lyfleysu samanburðarrannsókn
Guðmundur Vikar Einarsson, Jens Thorup Andersen, Þorsteinn Gíslason, Hans Wolf, Peter Ekman,
Hans Olav Beisland, Jan-Erik Johansson, Matti Kontturi, Timo Lehtonen, Kjell Tveter og skandinav-
íski rannsóknarhópurinn um góðkynja stækkun á blöðruhálskirtli*
Can finasteride reverse the progress of benign pros-
tatic hyperplasia? A two-year placebo-controllcd
study
Einarsson GV, Andersen JT, Gíslason Þ, Wolf H,
Ekman P, Beisland HO, Johansson J-E, Kontturi M,
Lehtonen T, Tveter K and the Scandinavian BPH
study group
Læknablaðið 1996; 82 : 859-66
Objective: To study if placebo-induced improve-
ment in men with symptomatic benign prostatic hy-
perplasia (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, pla-
cebo-controlled study involving 707 patients with
moderate symptoms of BPH enrolled at 59 centers
in five Scandinavian countries. Following enroll-
ment and a four-week single-blind placebo run-in
period, patients were randomized to receive finaste-
ride 5 mg once daily or placebo for 24 months.
Fyrirspurnir, bréfaskipti: Guðmundur Vikar Einarsson,
þvagfæraskurðdeild Landspítalans, 101 Reykjavík. Tölvu-
póstur: gudmein@rsp.is
Meðfylgjandi grein hefur áður birst í tímaritinu Urology (Can
finasteride reverse the progress of benign prostatic hyper-
plasia? A two-year placebo-controlled study. Urology 1995;
46: 631-7) og er birt hér með góðfúslegu leyfi tímaritsins.
* Sjáviðauka
Urinary symptoms, urinary flow rate, prostate vol-
ume, postvoiding residual urinary volume, and ser-
um concentrations of prostate-specific antigen to-
gether with laboratory safety parameters were
measured at entry and at months 12 and 24. Interim
physical and laboratory examinations were perform-
ed 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 pa-
tients, there was an initial improvement in the symp-
tom 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 re-
turn to baseline or deterioration of these parameters
during the study. These results demonstrate that
finasteride can reverse the natural progression of
BPH.
Ágrip
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?