March 1, 2022Translational Andrology and UrologyOpen Access

The efficacy and safety of dutasteride and finasteride in patients with benign prostatic hyperplasia: a systematic review and meta-analysis

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Why the study?

Although the efficacy and safety of monotherapy for benign prostatic hyperplasia have been clinically established, dutasteride and finasteride had not been directly compared.

Does dutasteride improve maximum urinary flow rate and other clinical parameters compared to finasteride in patients with benign prostatic hyperplasia?

Structured PICO

Does dutasteride improve maximum urinary flow rate and other clinical parameters compared to finasteride in patients with benign prostatic hyperplasia?

Population

2,116 patients with benign prostatic hyperplasia (BPH) across 8 RCTs

Intervention

Dutasteride

Comparator

Finasteride

Outcome

Maximum urinary flow rate (Qmax)surrogate

Dutasteride provides a modest but statistically significant improvement in maximum urinary flow rate compared to finasteride in patients with BPH, with similar symptom relief and safety profiles.

Limitations

Limitations of the methodological quality of included studies
Sample size of the included studies

Implication

Dutasteride offers modestly better Qmax improvement than finasteride; reinforces comparable efficacy and safety for BPH symptom control.

Abstract

Background: Although the efficacy and safety of monotherapy in the treatment of benign prostatic hyperplasia (BPH) have been established clinically, the efficacy and safety of dutasteride and finasteride have not been compared. The aim was to systematically evaluate the efficacy and safety of the two drugs in the treatment of BPH to provide medical evidence for clinical treatment. Methods: A search of relevant articles was conducted using the electronic databases PubMed, Embase, Medline, Cochrane Library, China Academic Journals Full-text Database (CJFD), Chinese Science and Technology Journal Database (VIP) and Wanfang Database. Randomized controlled trials (RCTs) comparing the efficacy of finasteride (control group) with that of dutasteride (experimental group) in the treatment of BPH with respect to the International Prostate Symptom Score (IPSS), the maximum urinary flow rate (Qmax), prostate volume (PV), quality of life (QOL), serum prostate-specific antigen (PSA) level and adverse drug reactions (ADRs) after medication were strictly evaluated and considered for inclusion. Rev Man 5.4 software was used for the meta-analysis. Results: A total of 8 RCTs were included, with a total of 2,116, patients. The meta-analysis showed that compared with finasteride, dutasteride can effectively improve the Qmax of patients with BPH [mean difference (MD) =0.32; 95% confidence interval (CI): (0.01, 0.63); P=0.04]. There was no significant difference in reducing IPSS [MD =0.13; 95% CI: (-0.55, 0.82); P=0.70], improving PV [MD =-1.25; 95% CI: (-3.30, 0.79); P=0.23], reducing QOL [MD =-0.44; 95% CI: (-0.93, 0.05); P=0.08] and serum PSA level [MD =-0.04; 95% CI: (-0.15, 0.07); P=0.50], and the occurrence of ADRs [relative risk (RR) =-0.01; 95% CI: (-0.05, 0.04); P=0.72], there was no significant difference. Discussion: Dutasteride is better than finasteride in improving the Qmax of patients with BPH. There was no statistically significant difference in symptoms, PV, PSA, QOL, or adverse reactions. Dutasteride is an effective and safe treatment for BPH. Due to the limitations of the methodological quality and sample size of the included studies, this conclusion needs to be verified by stratified RCTS with high volumes and long follow-up times.