Long-term therapy with the dual 5alpha-reductase inhibitor dutasteride is well tolerated in men with symptomatic benign prostatic hyperplasia.
OBJECTIVE
To examine the long-term (4-year) safety and tolerability of dutasteride in the treatment of symptomatic benign prostatic hyperplasia (BPH).


METHODS
Patients who completed the double-blind phase of three dutasteride Phase III studies were eligible to enter a 2-year open-label extension, during which all patients received dutasteride 0.5 mg. Safety was assessed, including adverse-event reporting, clinical laboratory assessments, yearly physical examinations, and vital sign assessments.


RESULTS
In all, 2340 patients entered the open-label phase, 1188 of whom previously received dutasteride during the double-blind phase of the study. The most common drug-related adverse events (occurring in > or = 1%) were effects on sexual function, which decreased with a longer duration of therapy. Gynaecomastia was reported in a small percentage of men throughout the 4-year study period. The incidence of individual sexual functional adverse events that led to withdrawal was < or = 1% (0.3-1.0%) during the 4-year study period. Dutasteride had no relevant effects on vital signs or clinical laboratory variables.


CONCLUSIONS
These data show that dutasteride is well tolerated during long-term use for the treatment of symptomatic BPH.
Schulman
Claude
C
Department of Urology, University Clinics of Brussels, Erasme Hospital, Brussels, Belgium. claude.schulman@ulb.ac.be
Pommerville
Peter
P
Höfner
Klaus
K
Wachs
Barton
B
D058891:5-alpha Reductase Inhibitors; D000368:Aged; D001378:Azasteroids / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D000068538:Dutasteride; D004791:Enzyme Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D006177:Gynecomastia / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000188:drug therapy*
D058891:5-alpha Reductase Inhibitors; D001378:Azasteroids; D004791:Enzyme Inhibitors; D000068538:Dutasteride