Urology 2002 Sep;60(3):434
Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and
2(dutasteride) in men with benign prostatic hyperplasia.
Roehrborn C, Boyle P, Nickel J, Hoefner K, Andriole G.
Department of Urology, University of Texas Southwestern Medical Center
at Dallas, Dallas, Texas, USA
To study the efficacy and safety of dutasteride, a dual inhibitor of
the 5-alpha-reductase isoenzymes types I and II.Methods. A total of 4325
men (2951 completed) with clinical benign prostatic hyperplasia, moderate
to severe symptoms (American Urological Association-Symptom Index score
of 12 points or greater), a peak flow rate of 15 mL/s or less, a prostate
volume of 30 cm(3) or greater (as measured by transrectal ultrasonography),
and a serum prostate-specific antigen level of 1.5 to 10.0 ng/mL (inclusive)
were enrolled into three identical clinical trials and randomized to 0.5
mg dutasteride daily or placebo. After a 1-month, single-blind, placebo
lead-in, patients were followed up for 24 months in a double-blind trial
with multiple interval assessments.
At 24 months, serum dihydrotestosterone was reduced from baseline by
a mean of 90.2% (median -93.7%; P <0.001), and the total prostate and
transition zone volumes were reduced by a mean of 25.7% and 20.4%, respectively
(P <0.001). The symptom score was improved by as early as 3 months,
with pooled significance from 6 months onward (P <0.001) and a reduction
points (21.4%) at 24 months (P <0.001). The maximal flow rate improved
significantly from 1 month (P <0.01), with an increase of 2.2 mL/s
reported at 24 months (P <0.001). Hence, the risk reduction of acute
urinary retention was 57% and the risk reduction of benign prostatic hyperplasia-related
surgical intervention was 48% compared with placebo. The drug was well
Dutasteride is a potent inhibitor of dihydrotestosterone production
that is safe and effective in terms of the reduction of prostate volume
and symptoms, flow rate improvement, and the reduction of the risk of
acute urinary retention and surgery during a 24-month study period.
PMID: 12350480 [PubMed - in process]