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Abstract
This study sought to assess the efficacy, tolerability, and effect of finasteride
on health-related quality of life (HRQL) in a diverse population of men with moderate-to-severe
symptomatic benign prostatic hyperplasia (BPH). This double-blind study evaluated
finasteride and placebo for 12 months in 2342 men with BPH (16.2% black, 14.5% Hispanic,
69.3% Caucasian/other) in a community-based setting. At 3-month intervals, urinary
symptoms were measured by use of the American Urologic Association symptom index.
HRQL was assessed by use of the BPH impact index (BII), which evaluated degree of
bother, worry, physical discomfort, and restriction in activities as a result of urinary
symptoms. Additional questions regarding activities of living were administered, and
global assessments of change in urologic status were performed by both patients and
investigators. Compared with placebo, patients treated with finasteride had a statistically
significant decrease in symptom scores when first measured at month 3. Symptom scores
continued to improve in finasteride-treated patients throughout the study; at month
12, the mean decrease in symptom scores in the finasteride-treated patients was −4.8
compared with −3.4 for placebo patients (P = 0.0001). Statistically significant differences in favor of finasteride also were
noted at month 12 on the BII (P = 0.0465), and finasteride-treated patients experienced less interference with activities
of living (P = 0.0518). Patient and investigator global assessments of urologic status showed
that significantly more patients in the finasteride group considered themselves improved
and were considered improved by investigators at month 12 (P = 0.000). Finasteride was generally well tolerated. The incidence of drug-related
sexual adverse experiences was significantly higher in the finasteride group (P = 0.000), but led to withdrawal in only 1.5% of patients. The demonstrated efficacy
and tolerability of finasteride in reducing symptoms and improving quality of life
confirm observations of previous trials and make finasteride a highly desirable treatment
option for many men with symptomatic BPH.
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© 1995 Published by Elsevier Inc.
