THE COST-EFFECTIVENESS OF TERAZOSIN AND PLACEBO IN THE TREATMENT OF MODERATE TO SEVERE BENIGN PROSTATIC HYPERPLASIA

Objectives. To evaluate the cost-effectiveness and functional status e ffects of terazosin, an alpha,(1)-adrenoceptor antagonist, compared wi th placebo in the treatment of men with moderate to severe, symptomati c, benign prostatic hyperplasia [BPH]. Methods. Prospective, randomize d, 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 mo nth thereafter for 12 months. Other information, such as American Urol ogic 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 basel ine men had at least moderate BPH symptoms by AUA Symptom Score (15 or more) and Bother Score (8 or more). On entry, patients at regional si tes had peak urinary Row rates 15 mL/s or less and total voided urine volumes 150 mt or greater. A total of 1053 patients were randomized to terazosin and 1031 to placebo treatment. Primary outcome measures inc luded payments for all direct medical resource consumption (inpatient care, emergency department care, outpatient care, and medications); ch anges in three AUA disease-specific functional status indicators (Symp tom, Bother, and Quality of Life scores), and nondisease-specific func tional status measures (days of work loss, days of customary activity loss, and days of bed rest). Results. Total payments for health care r esources (including study drug medication), adjusted to reflect 1000 p atients per treatment group, were $3,781,803 acid $5,568,263 in the pl acebo and terazosin groups, respectively. All three AUA disease-specif ic functional status scores improved significantly more in the terazos in group than in the placebo group. We found no difference between ter azosin and placebo in all three nonspecific functional status measures . Conclusions. Compared with placebo, terazosin therapy for moderate t o severe symptomatic BPH results in approximately equivalent payments for direct medical care, better disease-specific functional status imp rovement, and comparable change in nondisease-specific functional stat us measures.