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A randomized, comparative, open-label study of efficacy and tolerability of alfuzosin, tamsulosin and silodosin in benign prostatic hyperplasia.
Indian J Pharmacol. 2016 Mar-Apr; 48(2):134-40.IJ

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.

Authors+Show Affiliations

Department of Pharmacology, Kempegowda Institute of Medical Sciences, Bengaluru, Karnataka, India.Department of Pharmacology, Kempegowda Institute of Medical Sciences, Bengaluru, Karnataka, India.Department of Urology, Kempegowda Institute of Medical Sciences Hospital and Research Centre, Bengaluru, Karnataka, India.Department of Urology, Kempegowda Institute of Medical Sciences Hospital and Research Centre, Bengaluru, Karnataka, India.Department of Urology, Kempegowda Institute of Medical Sciences Hospital and Research Centre, Bengaluru, Karnataka, India.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27127315

Citation

Manjunatha, R, et al. "A Randomized, Comparative, Open-label Study of Efficacy and Tolerability of Alfuzosin, Tamsulosin and Silodosin in Benign Prostatic Hyperplasia." Indian Journal of Pharmacology, vol. 48, no. 2, 2016, pp. 134-40.
Manjunatha R, Pundarikaksha HP, Madhusudhana HR, et al. A randomized, comparative, open-label study of efficacy and tolerability of alfuzosin, tamsulosin and silodosin in benign prostatic hyperplasia. Indian J Pharmacol. 2016;48(2):134-40.
Manjunatha, R., Pundarikaksha, H. P., Madhusudhana, H. R., Amarkumar, J., & Hanumantharaju, B. K. (2016). A randomized, comparative, open-label study of efficacy and tolerability of alfuzosin, tamsulosin and silodosin in benign prostatic hyperplasia. Indian Journal of Pharmacology, 48(2), 134-40. https://doi.org/10.4103/0253-7613.178825
Manjunatha R, et al. A Randomized, Comparative, Open-label Study of Efficacy and Tolerability of Alfuzosin, Tamsulosin and Silodosin in Benign Prostatic Hyperplasia. Indian J Pharmacol. 2016 Mar-Apr;48(2):134-40. PubMed PMID: 27127315.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, comparative, open-label study of efficacy and tolerability of alfuzosin, tamsulosin and silodosin in benign prostatic hyperplasia. AU - Manjunatha,R, AU - Pundarikaksha,H P, AU - Madhusudhana,H R, AU - Amarkumar,J, AU - Hanumantharaju,B K, PY - 2016/4/30/entrez PY - 2016/4/30/pubmed PY - 2017/5/18/medline KW - alfuzosin KW - benign prostatic hyperplasia KW - clinical trial KW - silodosin KW - tamsulosin KW - α1-blockers SP - 134 EP - 40 JF - Indian journal of pharmacology JO - Indian J Pharmacol VL - 48 IS - 2 N2 - 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. SN - 1998-3751 UR - https://www.unboundmedicine.com/medline/citation/27127315/A_randomized_comparative_open_label_study_of_efficacy_and_tolerability_of_alfuzosin_tamsulosin_and_silodosin_in_benign_prostatic_hyperplasia_ L2 - http://www.ijp-online.com/article.asp?issn=0253-7613;year=2016;volume=48;issue=2;spage=134;epage=140;aulast=Manjunatha DB - PRIME DP - Unbound Medicine ER -