Objectives. To evaluate the cost-effectiveness and functional status effects of terazosin, an alpha1-adrenoceptor antagonist, compared with placebo in the treatment of men with moderate to severe, symptomatic, benign prostatic hyperplasia (BPH). Methods. Prospective, randomized, double-blind, placebo-controlled multicenter trial of 2084 patients was conducted at 15 academic regional centers and 141 community-based satellite centers. Information about the use of health care resources and nondisease-specific functional status measures was collected by a standardized telephone interview of patients at baseline and every month thereafter for 12 months. Other information, such as American Urologic Association (AUA) disease-specific functional status scores, was obtained from the patient study records. Patients had a mean age of 65.7 years (range, 46 to 94), with a clinical diagnosis of BPH. At baseline men had at least moderate BPH symptoms by AUA Symptom Score (13 or more) and Bother Score (8 or more). On entry, patients at regional sites had peak urinary flow rates 15 mL/s or less and total voided urine volumes 150 mL or greater. A total of 1053 patients were randomized to terazosin and 1031 to placebo treatment. Primary outcome measures included payments for all direct medical resource consumption (inpatient care, emergency department care, outpatient care, and medications); changes in three AUA disease-specific functional status indicators (Symptom, Bother, and Quality of Life scores), and nondisease-specific functional status measures (days of work loss, days of customary activity loss, and days of bed rest). Results. Total payments for health care resources (including study drug medication), adjusted to reflect 1000 patients per treatment group, were $3,781,803 and $3,568,263 in the placebo and terazosin groups, respectively. All three AUA disease-specific functional status scores improved significantly more in the terazosin group than in the placebo group. We found no difference between terazosin and placebo in all three nonspecific functional status measures. Conclusions. Compared with placebo, terazosin therapy for moderate to severe symptomatic BPH results in approximately equivalent payments for direct medical care, better disease-specific functional status improvement, and comparable change in nondisease-specific functional status measures.
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