Long-term 6-year experience with finasteride in patients with benign prostatic hyperplasia.
OBJECTIVE
To summarize the 6-year clinical trial data with finasteride. Benign prostatic hyperplasia is a chronic and progressive disease and therefore assessment of long-term safety and efficacy is important.


METHODS
The North American and International Phase III Finasteride trials enrolled symptomatic men with enlarged prostate glands. The initial 1-year placebo-controlled study was followed by a 5-year open-label extension. In total, 6-year finasteride data were available in 487 patients originally randomized to finasteride, and 5-year data were available on 238 patients originally randomized to placebo.


RESULTS
After 6 years of treatment with finasteride 5 mg, the mean quasi-American Urological Association Symptom Score improved by 4.0 points, the median prostate volume decreased by 24%, and the mean maximal urinary flow rate increased by 2.9 mL/s (P <0.001 for all parameters). Long-term finasteride treatment was well tolerated, with a low incidence of drug-related sexual adverse events occurring during the first year and even fewer occurrences during the 5-year open extension.


CONCLUSIONS
Treatment with finasteride leads to durable improvement in urinary tract symptoms, flow rate, and prostate volume, with no increase in the prevalence of drug-related adverse events over time.
Lowe
Franklin C
FC
Department of Urology, Saint Luke's-Roosevelt Hospital Center, New York, NY 10019, USA.
McConnell
John D
JD
Hudson
Perry B
PB
Romas
Nicholas A
NA
Boake
Rex
R
Lieber
Michael
M
Elhilali
Mostafa
M
Geller
Jack
J
Imperto-McGinely
Juliane
J
Andriole
Gerald L
GL
Bruskewitz
Reginald C
RC
Walsh
Patrick C
PC
Bartsch
Georg
G
Nacey
John N
JN
Shah
Sukrut
S
Pappas
Frances
F
Ko
Amy
A
Cook
Thomas
T
Stoner
Elizabeth
E
Waldstreicher
Joanne
J
D058891:5-alpha Reductase Inhibitors; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D007172:Erectile Dysfunction / Q000139:chemically induced; D018120:Finasteride / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010919:Placebos; D011467:Prostate / Q000473:pathology; D011470:Prostatic Hyperplasia / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology; D020018:Sexual Dysfunctions, Psychological / Q000139:chemically induced; D016896:Treatment Outcome
D058891:5-alpha Reductase Inhibitors; D004791:Enzyme Inhibitors; D010919:Placebos; D018120:Finasteride