5α-Reductase Inhibitors for Treatment of Benign Prostatic Hyperplasia: A Systematic Review and Meta-Analysis.

backgroundFinasteride and dutasteride are competitive inhibitors of 5α-reductase enzymes and are commonly used to treat symptomatic benign prostatic hyperplasia (BPH).

objectiveTo compare the efficacy and safety of finasteride and dutasteride in terms of clinically important outcomes. DATA SOURCES: A literature search was performed using the search terms "prostatic hyperplasia", "prostatic hypertrophy", "dutasteride", "finasteride", "quality of life", "adverse drug reaction", and "mortality". The Embase, PubMed, Cochrane Central Register of Controlled Trials, International Pharmaceutical Abstracts, Cumulative Index to Nursing and Allied Health Literature, and Latin American and Caribbean Health Sciences Literature databases were searched from inception to December 2015. STUDY SELECTION AND DATA EXTRACTION: Randomized controlled trials, quasi-randomized trials, and systematic reviews comparing finasteride with dutasteride, either as monotherapy or in combination with α-blockers, for treatment of men with BPH were included. The outcomes of interest included need for prostate-related surgery, episodes of acute urinary retention, withdrawals due to adverse events, number of patients experiencing serious adverse events, mortality, and sexual dysfunction. DATA SYNTHESIS: Four studies involving a total of 1879 patients were included in the analysis. There were no significant differences in any of the clinically important outcomes examined: for prostate-related surgery, odds ratio (OR) 2.01 (95% confidence interval [CI] 0.18-22.24); for episodes of acute urinary retention, OR 1.47 (95% CI 0.68-3.19); for number of withdrawals due to adverse events, OR 1.10 (95% CI 0.68-1.75); for total number of patients experiencing adverse events, OR 0.94 (95% CI 0.78-1.14); for number of patients experiencing serious adverse events, OR 1.31 (95% CI 0.87-1.97); and for sexual dysfunction, OR 0.83 (95% CI 0.64-1.08).

conclusionThere is insufficient evidence to suggest that either finasteride or dutasteride offers an advantage in efficacy or safety over the other, in terms of clinically important outcomes.