Dutasteride is a competitive inhibitor of the enzyme 5-alpha-reductase and is commonly used to treat the symptoms of benign prostatic hyperplasia (BPH).
Objective: to determine the efficacy and safety of dutasteride in terms of indicators that are important in clinical practice.
Data sources. The literature was searched using the search terms «prostate hyperplasia», «prostate hypertrophy», «dutasteride», «quality of life», and «adverse drug reaction». Articles were obtained from Embase, PubMed, the Kokhranov Central Register of Controlled Trials, with a search till December 2020.
Study selection and data recovery. Randomized controlled trials, quasi-randomized trials, and systematic reviews evaluating the efficacy of dutasteride, both in monotherapy and in combination with alpha-blockers for the treatment of men with BPH were included in the analysis. Indicators were the need for prostate surgery, episodes of acute urinary retention, discontinuation of therapy due to side effects, the number of patients who had serious side effects, mortality and sexual dysfunction.
Data analysis. Four studies involving 1,879 patients were evaluated. All studies have shown significant clinical efficacy of dutasteride to the need for prostate surgery, with episodes of acute urinary retention that was higher than finasteride with equal safety profiles.
Conclusion. No statistically significant differences between the two 5AR inhibitors finasteride and dutasteride in terms of safety profile were found, based on the studies included in this system review. This determines the best clinical efficacy of dutasteride in terms of the number of cases of acute urinary retention and the need for surgery.
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