Abstract
Objective: Given the economic burden of prostate cancer (PCa), a PCa risk-reduction medication would be desirable. A within-trial economic analysis of the Reduction by Dutasteride of Prostate Cancer Events (REDUCE) study was performed. Methods: REDUCE, a 4-year, randomized, double-blind, placebo-controlled, parallel-group clinical trial, compared efficacy and safety of dutasteride 0.5 mg daily and placebo to reduce the risk of PCa in men at increased risk. Resource use was prospectively collected; costs from standard costing sources were applied. Utilities were obtained from published literature. Relative risks and Wilcoxon rank sums were used to examine differences between treatments. Results: Placebo patients were at significantly higher risk (P < 0.05) for concomitant medication use; and health care visits related to surgical procedures, unscheduled biopsies, acute urinary retention, urinary tract infections, or macroscopic hematuria. Total costs were significantly lower (P < 0.001) in dutasteride patients ($1 300; 95% confidence interval: $806, $1 795). Incremental cost per quality-adjusted life-year (QALY) was $26 516; cost per PCa case avoided was $19. Conclusions: During the 4-year trial period, men at increased risk for PCa receiving dutasteride incurred fewer health care costs than men receiving placebo, which helped offset dutasteride costs. Dutasteride was good value for money.
Highlights
Prostate cancer (PCa) is one of the most common cancers in American men and the second leading cause of cancer death [1]
Finasteride has been shown to reduce the incidence of PCa by 24.8% (95% confidence interval [Confidence interval (CI)]: 18.6%-30.6%; P < 0.001) in men with serum prostate-specific antigen (PSA) < 3.0 ng/ mL in the Prostate Cancer Prevention Trial [3]
The Reduction by Dutasteride of Prostatic Cancer Events (REDUCE) clinical trial was approved by the institutional review boards at each research site, and all participants provided written informed consent [4]
Summary
Prostate cancer (PCa) is one of the most common cancers in American men and the second leading cause of cancer death [1]. Medical expenditures for PCa were estimated to be $11.85 billion in 2010 and projected to reach $16.34 billion in 2020 (in 2010 dollars) [2]. Given this burden, medication to reduce the risk of PCa could provide economic and quality-of-life benefits. The use of 5-alpha reductase inhibitors (5ARIs) has been studied for PCa risk reduction. In a recent clinical trial, the Reduction by Dutasteride of Prostatic Cancer Events (REDUCE), dutasteride (0.5 mg/day) was shown to reduce the risk of PCa by 22.8% (95% CI: 15.2%-29.8%; P < 0.001) compared with placebo in men with a negative biopsy and PSA > 2.5 ng/mL at baseline [4]
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