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In a 4-year industry-sponsored study of 3040 men with symptomatic benign prostatic hyperplasia (BPH), the incidence of a combined endpoint -- acute urinary retention or BPH-related surgery -- was significantly lower among men who took finasteride than among placebo recipients (6.6% vs. 13.2%; Journal Watch Mar 3 1998). To determine whether this benefit continued, the investigators conducted a 2-year open-label extension of the trial, during which most finasteride recipients continued taking the drug, and most placebo recipients switched to finasteride.
During the first 4 years of the trial, the rate of the combined endpoint was roughly 3%-4% per year in the placebo group and 1%-2% per year in the finasteride group. During years 5 and 6, when…