Clinical effect s and economical impact of du t ast eride and fi nast eride t herapy in It alian men w it h LUTS

Objectives: To investigate differences in the risk of benign prostatic hyperplasia (BPH)related hospitaliz ation, for surgical and non-surgical reasons, and of new prostate can cer (PCa) diagnosis between patients under dutasteride or fi nasteride treatment. Material and methods: A retrospective cohort study was conducted using data from record-linkage of administrative databases. Men aged ≥ 40 years old who had received a prescription for at least 10 boxes/year (index years: 2004-06) were included. The association of the outcomes was assessed using a multiple Cox proportional haz ard model. Propensity scorematched analysis and a 5-to-1, greedy 1:1 matching algorithm were performed. The budget impact analysis of dutasteride vs fi nasteride in BPH-treated patient was performed. Results: From an initial cohort of about 1.5 million of Italian men, 19620 were selected. The over all hospitaliz ation for BPH-non surgical reasons, for BPH-related surgery and for new detection of PCa incidence rates (IRs) were 8.20 (95% CI, 7.62-8.23), 18.0 (95% CI, 17.12-18.93) and 8.62 (95% CI, 8.03-9.26) per 1000 person-years, respectively. The multivariate analysis after the propensity score-matching showed that dutasteride was associated with an independent reduced likelihood of hospitaliz ation for BPH-related surgery (HR 0.82; 95% CI 0.73-0.93; p = 0.0025) and of newly detected PCa (HR: 0.76,95% CI, 0.65-0.85; p = 0.0116). The IR for BPH-non surgi cal reasons was 8.07 (95% CI, 7.10-9.17) and 9.25 (95% CI, 8.19-10.44) per 1000 person-years, respectively. The IR for BPH-related surgery was 18.28 (95% CI, 17.17-20.32) and 21.28 (95% CI, 19.24-23.06) per 1000 person-years among patients under dutasteride compared with those under fi nasteride, respectively. For new-onset PCa, the IR was 8.01 (95% CI, 7.07-9.08) and 9.38 (95% CI, 8.32-10.58) per 1000 person-years The pharmacoeconomical evaluation showed that the net budget impact of the use of dutasteride vs. fi nasteride in 1000 BPH-treated patient for 1 year induces a saving of 3933 € . Conclusions: The clinical effects of dutasteride and fi nasteride are slightly different. The likeli hood of hospitaliz ation for BPH-related surgery and of newly detected PCa seems to be in favor of dutasteride. The budget impact analyses showed a slightly benefi t for dutasteride. Comparative prospective studies are necessary to confi rm these results.