Abstract
Background: Silodosin is a new high-selective α1A-adrenoceptors antagonist. A systematic review of literature and meta-analysis were performed to compare the clinical efficacy and safety outcomes of silodosin with placebo, tamsulosin, naftopidil and alfuzosin in treating benign prostatic hyperplasia (BPH) males with lower urinary tract symptoms (LUTS). Materials and Methods: We systematically searched literature among EMBASE, PubMed, Cochrane Library, ScienceDirect and Web of Science databases until April 2019. 18 related randomized controlled trials were included according to eligibility criteria. Random-effects model were applied for data analysis. Results: 5,985 patients were included in our study. Silodosin presented superiority to placebo in improving LUTS and better efficacy than tamsulosin and naftopidil in improving IPSS void subscore and post-void residual urine volume with statistically significance (all P values < 0.05). Greater QoL index improvement were found in silodosin than alfuzosin groups (MD = -0.44, 95%CI: [-0.83, -0.05], P = 0.03) while no differences in total IPSS score and Qmax changes between these two groups. Retrograde ejaculation was significantly frequent in silodosin than placebo, tamsulosin and naftopidil groups (all P values < 0.05). Besides, silodosin increased incidence of upper respiratory tract infection compared to tamsulosin groups (RR = 0.69, 95%CI: [0.50, 0.96], P = 0.03). A higher rate of nasal congestion (RR = 7.76, 95%CI: [1.80, 33.41], P = 0.006) were found in silodosin than placebo groups while no difference for nasopharyngitis ((RR = 1.16, 95%CI: [0.54, 2.47], P = 0.71). Prevalence of headache (RR = 0.54, 95%CI: [0.27, 1.06], P = 0.07) and postural hypotension (RR = 0.14, 95%CI: [0.03, 0.77], P = 0.02) were lower in silodosin than tamsulosin groups, although dizziness and vertigo was more frequent in silodosin than placebo (RR = 2.26, 95%CI: [1.21, 4.21], P = 0.009). Conclusions: Our study demonstrated silodosin’s possible superiority to placebo and naftopidil while noninferiority to tamsulosin and alfuzosin in LUTS improvement of BPH males. Better cardiovascular safety was in silodosin groups, although incidence of retrograde ejaculation and respiratory adverse events were higher.
Systematic review and meta-analysis of efficacy and safety of silodosin in treatment of benign prostatic hyperplasia patients with lower urinary tract symptoms
