A randomized, comparative, open-label study of efficacy and tolerability of alfuzosin, tamsulosin and silodosin in benign prostatic hyperplasia

Abstract

Objectives:Benign prostatic hyperplasia (BPH) is a common and progressive disease affecting elderly males, often associated with lower urinary tract symptoms (LUTS). α1-blockers are the mainstay in symptomatic therapy of BPH. Because of their greater uroselectivity and minimal hemodynamic effects, alfuzosin, tamsulosin, and silodosin are generally preferred. The aim of this study was to compare the efficacy and tolerability of alfuzosin, tamsulosin, and silodosin in patients with BPH and LUTS.Methods:Ninety subjects with BPH and LUTS were randomized into three groups of thirty in each, to receive alfuzosin sustained release (SR) 10 mg, tamsulosin 0.4 mg, or silodosin 8 mg for 12 weeks. The primary outcome measure was a change in the International Prostate Symptom Score (IPSS), and the secondary outcome measures were changes in individual subjective symptom scores, quality of life score (QLS), and peak flow rate (Qmax) from baseline. The treatment response was monitored at 2, 4, 8, and 12 weeks.Results:IPSS improved by 88.18%, 72.12%, and 82.23% in alfuzosin SR, tamsulosin and silodosin groups (P < 0.001) at 12 weeks. Improvement in QLS was >75% in all the three groups (P < 0.001). A significant improvement in Qmax was seen with alfuzosin and tamsulosin (P = 0.025 and P < 0.001) but not with silodosin (P = 0.153). However, the intergroup differences in IPSS, QLS, and Qmax were not significant. Ejaculatory dysfunction was more common with silodosin and corrected QT (QTc) prolongation occurred only with alfuzosin (two subjects) and tamsulosin (three subjects).Conclusion:Alfuzosin, tamsulosin, and silodosin showed similar efficacy in improvement of LUTS secondary to BPH, with good tolerability, acceptability, and minimum hemodynamic adverse effects. Alfuzosin, tamsulosin, and silodosin are comparable in efficacy in symptomatic management of BPH. The occurrence of QTc prolongation in three subjects with tamsulosin in the present study is an unexpected adverse event as there are no reports of QTc prolongation with tamsulosin in any of the previous studies.

To compare the efficacy and safety of silodosin and dutasteride combination with alfuzosin and dutasteride combination in patients of benign prostatic hyperplasia: a randomized, open label study

“…2 Early onset of improvement in I-PSS has been reported for silodosin treated patients within 3-4 days, 14 days and 4 weeks respectively by many studies. 16,17,20 Similarly, an early and significant onset of improvement in I-PSS in alfuzosin treated patients has been observed Saad F et al 19 In the present study significant and comparable improvement was observed on the QoL due to urinary symptoms in both the treatment groups (p <0.001).…”

“…Decline in I-PSS with silodosin has been reported by various studies. 2,[15][16][17] In the present study, for SD combination mean change in I-PSS from baseline was (-7.15) at 12 weeks. A similar decrease (-8.3) and (-6.4) in mean I-PSS from baseline with silodosin was reported by many 12-week studies.…”

Comparative Effectiveness of Newer Medications for Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: A Systematic Review and Meta-analysis

“…Ten trials randomized men with LUTS attributed to BPH ( n = 1799) to silodosin 8 mg daily versus tamsulosin 0.2–0.4 mg daily [13–22]. Table 1 provides baseline characteristics.…”

“…Table 1 provides baseline characteristics. Overall, the RoB was low in two trials [13,18], moderate in six trials [14–16,20–22], and high in two trials [17,19]. …”

A prospective analysis of the cost-effectiveness of alfuzosin, tamsulosin and silodosin for 12 weeks in benign prostatic hyperplasia

“…IPSS was used to assess the severity of LUTS as described elsewhere. 10 IPSS was assessed at baseline and at the follow up visits after 2, 4, 8 and 12 weeks of treatment initiation by the investigator. The patients were instructed to carefully observe the severity of their urinary complaints and report the same when asked about it at the subsequent visit during the recording of the IPSS.…”