EFFICACY, TOLERABILITY, AND EFFECT ON HEALTH-RELATED QUALITY-OF-LIFE OF FINASTERIDE VERSUS PLACEBO IN MEN WITH SYMPTOMATIC BENIGN PROSTATICHYPERPLASIA - A COMMUNITY-BASED STUDY

This study sought to assess the efficacy, tolerability, and effect of finasteride on health-related quality of Life (HRQL) in a diverse popu lation of men with moderate-to-severe symptomatic benign prostatic hyp erplasia (BPH). This double-blind study evaluated finasteride and plac ebo for 12 months in 2342 men with BPH (16.2% black, 14.5% Hispanic, 6 9.3% Caucasian/other) in a community-based setting. At 3-month interva ls, urinary symptoms were measured by use of the American Urologic Ass ociation symptom index. HRQL was assessed by use of the BPH impact ind ex (BIE), which evaluated degree of bother, worry, physical discomfort , and restriction in activities as a result of urinary symptoms. Addit ional questions regarding activities of living were administered, and global assessments of change in urologic status were performed by both patients and investigators. Com pared with placebo, patients treated with finasteride had a statistically significant decrease in symptom s cores when first measured at month 3. Symptom scores continued to impr ove in finasteride-treated patients throughout the study; at month 12, the mean decrease in symptom scores in the finasteride-treated patien ts was -4.8 compared with -3.4 for placebo patients (P = 0.0001). Stat istically significant differences in favor of finasteride also were no ted at month 12 on the BII (P = 0.0465), and finasteride-treated patie nts experienced less interference with activities of living (P = 0.051 8). Patient and investigator global assessments of urologic status sho wed that significantly more patients in the finasteride group consider ed themselves improved and were considered improved by investigators a t 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 desirab le treatment option for many men with symptomatic BPH.