Efficacy and Safety of Combination Tamsulosin and Dutasteride versus Tamsulosin Monotherapy for Benign Prostatic Hyperplasia: A Meta-Analysis.

BACKGROUND

We conducted a meta-analysis to compare the efficacy and drug-related adverse events (AEs) of the combination of tamsulosin and dutasteride versus tamsulosin monotherapy for the treatment of benign prostatic hyperplasia (BPH).

METHODS

Relevant articles published in PubMed, Embase and Cochrane from 2004 to 2024 were searched and downloaded. These studies were screened following pre-established inclusion criteria, and data were extracted. Review Manager software was used for methodological quality assessment of randomised controlled trials and statistical analysis.

RESULTS

Eight studies containing 8793 patients were included in the meta-analysis. Combined dutasteride and tamsulosin more significantly improved symptoms (mean difference (MD): -1.55; 95% confidence interval (CI): -2.27, -0.84; p < 0.001), increased maximum urine flow (MD: 1.54; 95% CI: 1.18, 1.91; p < 0.001) and decreased prostate volume (MD: -14.42; 95% CI: -20.62, -8.22; p < 0.001) and prostate-specific antigen (MD: -2.32; 95% CI: -3.03, -1.61; p < 0.001) in patients with BPH than tamsulosin monotherapy. The combined drug also reduced the negative effect on patients' living status (MD: -0.68; 95% CI: -1.02, -0.33; p < 0.001), acute urinary retention or BPH-related surgeries (odds ratio (OR): 0.33; 95% CI: 0.25, 0.44; p < 0.001) and clinical progression of BPH (OR: 0.52; 95% CI: 0.44, 0.61; p < 0.001). However, the combination of dutasteride and tamsulosin significantly increased the incidence of drug-related AEs (OR: 2.13; 95% CI: 1.67, 2.73; p < 0.001) in patients with BPH.

CONCLUSIONS

In patients with BPH, the combination of dutasteride and tamsulosin is a beneficial treatment option, but the impact on drug-related AEs events needs to be considered on an individual basis.