EFFICACY AND TOLERABILITY OF FINASTERIDE IN SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA - A PRIMARY-CARE STUDY

Because increasing numbers of men are seeking treatment for benign pro static hyperplasia (BPH) from primary care physicians, we sought to as sess the efficacy and tolerability of finasteride in a primary care se tting. In this randomized, double-masked study, 2112 men with symptoma tic BPH received either finasteride (n = 1589) or placebo (n = 523) fo r 1 year. At 3, 6, 9, and 12 months, urinary symptoms were measured us ing the American Urological Association Symptom Index (AUASI). Quality of life was assessed using the BPH Impact Index (BII), which assessed bother, worry, physical discomfort, and restriction in activities. Bo th patients and investigators assessed overall urologic status. Invest igators assessed the effect of the drug on plasma lipids in a subset o f patients. Patients treated with finasteride had a statistically sign ificant mean decrease in AUASI scores compared with patients treated w ith placebo beginning at month 6 and continuing throughout the study. At month 12, adjusted mean decreases in AUASI scores were -4.96 for fi nasteride versus -3.71 for placebo. Statistically significant differen ces in favor of finasteride were also noted on BLT at months 9 and 12. Patient and investigator overall assessments showed greater improveme nt in the finasteride group beginning at month 6. The incidence of dru g-related sexual adverse experiences was significantly greater in fina steride-treated patients but led to withdrawal in only 2.2% of these p atients. Overall Lipid profile was not significantly altered in either group. Based on improvement in symptoms and quality of life, and on i ts favorable tolerability profile, finasteride should be considered by primary care physicians for management of symptomatic BPH.