OBJECTIVES: To compare the clinical and cost-effectiveness of dutasteride with placebo and finasteride in BPH. METHODS: Systematic review according to Cochrane Collaboration guidelines and clinical effectiveness analysis according to Polish Pharmacoeconomic Guidelines were performed. In the absence of relevant head-to-head RCT dutasteride vs finasteride on clinical hard endpoints, meta-analysis was performed using an indirect comparison, with placebo as the common reference (Bucher method). Cost-effectiveness Markov model was performed from payer perspective (health insurance), using costs data from published sources and a lifetime horizon. RESULTS: Dutasteride vs placebo: 3 clinical trials were included. Dutasteride treatment was associated with statistically significantly greater reduction in urological symptoms (AUA-SI scale) compared to placebo, with difference in changes of 1.1, 1.4 and 2.2 points after 12, 18 and 24 months, respectively. There was statistically significant difference in BPH Impact Index after 6 months (p<0.005) and after 24 months of follow-up (p<0.001). Dutasteride significantly reduced risk of acute retention of urine (OR=0,42), prostate cancer (OR=0.56) and necessity of surgical intervention (OR=0.51). Average costs (including costs of drugs, complications and prostate cancer treatment) and effects (life-years with no surgery/prostate cancer) were: dutasteride 5298 PLN/8 LY; placebo 2426 PLN/6.25 LY. ICER for dutasteride vs placebo comparison was 1645 PLN/LY without surgery/Prostate cancer. Dutasteride vs finasteride: 12 trials were included (1 direct and 11 indirect comparisons). All the results were obtained from indirect comparison. Dutasteride, compared to finasteride, significantly improved AUA-SI score (WMD= 1.53), and influenced PSA concentration (WMD=-1.33). Average costs (including drugs costs, complications and prostatic cancer treatment) and effects (LY with no surgery/prostatic cancer) were per patient: dutasteride 5655 PLN/6.23 LY; finasteride 6081 PLN/5.13 LY. Dutasteride was dominant therapy compared with finasteride (more effective and less costly). CONCLUSIONS: Dutasteride is clinically more effective and more cost-effective in BPH compared to both placebo and finasteride.