THE HYTRIN COMMUNITY ASSESSMENT TRIAL STUDY - A ONE-YEAR STUDY OF TERAZOSIN VERSUS PLACEBO IN THE TREATMENT OF MEN WITH SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA

Objectives. To determine the clinical effectiveness and safety of alph a(1)-blockade therapy versus placebo in the treatment of men with mode rate to severe symptoms of prostatism in a community-based population under usual care conditions. Methods. The Hytrin Community Assessment Trial is a prospective, placebo-controlled, randomized, double-blinded , 1-year clinical trial, conducted at 15 academic medical centers (reg ional sites) and 141 private urology practices (satellite sites). A to tal of 2084 men at]east 55 years old with moderate to severe symptoms of benign prostatic hyperplasia (BPH) as determined by an American Uro logical Association (AUA) Symptom Score (AUA-SS) of 15 or more points and a bother score (AUA-BS) of 8 or more were enrolled. Randomized pat ients at regional sites were required to have a peak urinary flow rate less than 15 mL/s with a voided volume of at least 150 mL. Treatment with terazosin was initiated with 1 mg daily for 3 days, followed by 2 mg daily for 25 days. Thereafter, patients were titrated stepwise to 5 or 10 mg if they failed to achieve a 35% or greater improvement in t he AUA-SS. Primary outcome measures were AUA-SS, AUA-BS, BPH Impact In dex (Bill, disease-specific quality of life [QOL) score, and treatment failure as defined as discontinuation due to persistent or worsening symptoms or need for surgical intervention for BPH. Secondary outcome measures were peak urinary flow rate and postvoid residual urine volum e. Results. AUA-SS (0 to 55 point scale) improved from a baseline mean of 20.1 points by 37.8% during terazosin (n = 976) and by 18.4% durin g placebo (n = 973) treatment (P < 0.001). Similarly, statistically su perior improvements were observed in regard to the AUA-BS, BII, and th e QOL score in the terazosin-treated patients. Peak urinary flow rate improved from a baseline of 9.6 mL/s (both regional treatment groups) by 2.2 mL/s in the terazosin group (n = 137) and by 0.7 mL/s in the pl acebo group (n = 140) (P less than or equal to 0.05). Treatment failur e occurred in 11.2% of terazosin- and 25.4% of placebo-treated patient s (P < 0.001; Kaplan-Meier adjusted withdrawal rates at 365 days). Wit hdrawal from study drug treatment due to adverse events occurred in 19 .7% of terazosin- and 15.2% of placebo-treated patients (P < 0.001). C onclusions. Terazosin given once daily in a dose ranging from 2 to 10 mg in community-based urology practices under conditions simulating us ual care is effective in reducing the symptoms, perception of bother, and the impairment of QOL due to urinary symptoms in men with moderate to severe symptoms of prostatism. This effect is superior to placebo and maintained over 12 months of follow-up. Clinical research outcome studies in BPH can be conducted in community-based practices, thus sim ulating as closely as possible ''usual care'' conditions.