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Randomized Controlled Trial
. 2016 Mar-Apr;48(2):134-40.
doi: 10.4103/0253-7613.178825.

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

R Manjunatha  1 , H P Pundarikaksha  1 , H R Madhusudhana  2 , J Amarkumar  2 , B K Hanumantharaju  2
Affiliations
Randomized Controlled Trial

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

R Manjunatha et al. Indian J Pharmacol. 2016 Mar-Apr.

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.

Keywords: alfuzosin; benign prostatic hyperplasia; clinical trial; silodosin; tamsulosin; α1-blockers.

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Figures

Figure 1
Figure 1
Comparison of alfuzosin, tamsulosin and silodosin in benign prostatic hyperplasia: Flow of study participants
Figure 2
Figure 2
Comparison of alfuzosin, tamsulosin and silodosin in benign prostatic hyperplasia: Change in International Prostatic Symptom Score in the three study groups: The change in mean International Prostate Symptom Score from baseline to 2 weeks (visit 1), 4 weeks (visit 2), 8 weeks (visit 3), and 12 weeks (visit 4) with the three study medications
Figure 3
Figure 3
Comparison of alfuzosin, tamsulosin and silodosin in benign prostatic hyperplasia: Change in quality of life score. The improvement in mean quality of life score from baseline to 2 weeks (visit 1), 4 weeks (visit 2), 8 weeks (visit 3), and 12 weeks (visit 4) with the three study medications
Figure 4
Figure 4
Comparison of alfuzosin, tamsulosin and silodosin in benign prostatic hyperplasia: Change in Qmax. The improvement in mean Qmax (peak flow rate) from baseline to 2 weeks (visit 1), 4 weeks (visit 2), 8 weeks (visit 3), and 12 weeks (visit 4) with the three study medications
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References

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