Meta-analysis of the efficacy and safety of combination of tamsulosin plus dutasteride compared with tamsulosin monotherapy in treating benign prostatic hyperplasia

Abstract

Background: We performed a meta-analysis to confirm the efficacy and safety of the combination of tamsulosin plus dutasteride compared with tamsulosin monotherapy in treating benign prostatic hyperplasia (BPH) during a treatment cycle of at least 1 year.

Methods: Randomized controlled trials were searched by using MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. Systematic review was carried out using the Preferred Reporting Items for Systematic Reviews and Meta-analyses. The data was evaluated and statistically analyzed by using RevMan version 5.3.0.

Results: Five studies including 4348 patients were studied. The analysis found that the combination group was significantly greater effect in international prostate symptom score (mean difference [MD], - 1.43; 95% confidence interval [CI], - 2.20 to - 0.66; P = 0.0003), prostate volume (MD, - 10.13; 95% CI, - 12.38 to - 7.88; P < 0.00001), transitional zone volume (MD, - 3.18; 95% CI, - 3.57 to - 2.79; P<0.0001), maximum urine flow rate (MD, 1.05; 95% CI, 0.82 to 1.29; P < 0.00001), prostate specific antigen (MD, - 0.54; 95% CI, - 0.80 to - 0.29; P < 0.0001) and post-void residual volume (MD, - 3.85; 95% CI, - 4.95 to - 2.76; P < 0.00001) compared with the tamsulosin group. In terms of safety, including adverse events (odds ratio [OR], 2.06; 95% CI, 1.34 to 3.17; P = 0.001), erectile dysfunction (OR, 2.24; 95% CI, 1.73 to 2.92; P < 0.00001), ejaculation disorder (OR, 3.37; 95% CI, 1.97 to 5.79; P < 0.0001), retrograde ejaculation (OR, 2.30; 95% CI, 1.08 to 4.93; P = 0.03), decreased libido (OR, 2.25; 95% CI, 1.53 to 3.31; P < 0.0001) and loss of libido (OR, 3.38; 95% CI, 1.94 to 5.88; P<0.0001), the combination group showed poor tolerance than the tamsulosin group with the exception of dizziness (OR, 1.16; 95% CI, 0.75 to 1.80; P = 0.50). The combination group significantly reduced the risk of clinical progression than the tamsulosin group especially in incidence of BPH-related symptom progression (OR, 0.56; 95% CI, 0.46 to 0.67; P < 0.00001) and acute urinary retention (OR, 0.61; 95% CI, 0.38 to 0.98; P = 0.04).

Conclusion: The combination of tamsulosin plus dutasteride provides a preferable therapeutic effect for BPH with a higher incidence of sexual side effects, but combination-therapy can markedly reduce risk of BPH-related symptom progression and acute urinary retention relative to tamsulosin monotherapy.

Keywords: Benign prostatic hyperplasia; Dutasteride; Meta-analysis; Randomized controlled trials; Tamsulosin.

Fig. 1

Flowchart of the study selection process. RCT, randomizeda controlled trials

Fig. 2

Funnel plot of the studies included in our meta-analysis. MD, mean difference; SE, standard error

Fig. 3

Forest plots showing changes in (a) international prostate symptom score; (b) prostate volume; (c) transitional zone volume; SD, standard deviation; IV, inverse variance; CI, confidence interval; df, degrees of freedom

Fig. 4

Forest plots showing changes in (a) maximum urine flow rate; (b) prostate specific antigen; (c) post-void residual volume; SD, standard deviation; IV, inverse variance; CI, confidence interval; df, degrees of freedom

Fig. 5

Forest plots showing numbers in (a) adverse Events; (b) erectile dysfunction; M-H, Mantel-Haenszel; CI, confidence interval; df, degrees of freedom

Fig. 6

Forest plots showing numbers in (a) ejaculation disorder; (b) retrograde ejaculation; M-H, Mantel-Haenszel; CI, confidence interval; df, degrees of freedom

Fig. 7

Forest plots showing numbers in (a) decreased libido; (b) loss of libido; (C) dizziness; M-H, Mantel-Haenszel; CI, confidence interval; df, degrees of freedom

Fig. 8

Forest plots showing numbers in (a) BPH-related symptom progression; (b) BPH-related acute urinary retention; (c) BPH-related urinary incontinence; (d) BPH-related urinary tract infection; (e) BPH-related renal insufficiency; M-H, Mantel-Haenszel; CI, confidence interval; df, degrees of freedom