Efficacy of finasteride is maintained in patients with benign prostatic hyperplasia treated for 5 years. The North American Finasteride Study Group.
OBJECTIVE
The purpose of this open-label study extension was to assess the long-term safety and efficacy of finasteride in the treatment of men with benign prostatic hyperplasia (BPH).


METHODS
A Phase III North American BPH trial originally enrolled 895 men, 297 of whom were randomized to receive finasteride 5 mg. An enlarged prostate gland by digital rectal examination, symptoms of urinary obstruction, and a maximal urinary flow rate of less than 15 mL/s were required for entry. Patients who completed the initial 12-month, double-blind, placebo-controlled study were invited to participate in an open-label extension for 4 additional years.


RESULTS
Of the 297 patients initially randomized to receive finasteride 5 mg, 259 completed 12 months in the double-blind period and 186 completed 48 months of open-label therapy. Prostate volume reached a nadir of -24.6% at month 24, and the effect was maintained through month 60. Compared with baseline values, month 60 prostate volume was decreased by 22.7% (P<0.001), the quasi-American Urological Association symptom score was decreased by 4.3 points, and maximal urinary flow was increased by 2.3 mL/s (P<0.001) on average. Finasteride was well tolerated, with no significant increase in the prevalence of sexual adverse events over time.


CONCLUSIONS
Patients treated with finasteride 5 mg maintained an initial decrease in prostate volume and improvement in symptom score and maximal urinary flow rate over 5 years.
Hudson
P B
PB
Tampa Bay Urological Institute, Seminole, Florida, USA.
Boake
R
R
Trachtenberg
J
J
Romas
N A
NA
Rosenblatt
S
S
Narayan
P
P
Geller
J
J
Lieber
M M
MM
Elhilali
M
M
Norman
R
R
Patterson
L
L
Perreault
J P
JP
Malek
G H
GH
Bruskewitz
R C
RC
Roy
J B
JB
Ko
A
A
Jacobsen
C A
CA
Stoner
E
E
D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D018120:Finasteride / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D010352:Patient Dropouts; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D013997:Time Factors
D004791:Enzyme Inhibitors; D018120:Finasteride