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

ABSTRACT

Background: BPH is a major cause of bothersome lower urinary tract symptoms (LUTS) and affects quality of life (QoL) which deteriorates if not taken care with the passage of time. The aim and objective of the study was to compare the efficacy and safety of combination of silodosin and dutasteride with the combination of alfuzosin and dutasteride in patients of BPH.Methods: A randomized, open label, intention to treat study was carried out on newly diagnosed patients of BPH. Patients were randomly divided into two groups and followed up to 12 weeks. Group 1 of patients received a combination of silodosin 8 mg and dutasteride 0.5 mg (SD) (n=20) while the patients of group 2 received combination of alfuzosin 10 mg and dutasteride 0.5 mg (AD) (n=20). Primary endpoint was measured by changes in the mean baseline International prostate symptom score (I-PSS) and uroflowmetry and secondary outcome with changes observed on ultrasonography.Results: IPSS and IPSS-QOL significantly improved in both the treatment groups (p <0.001) along with mean maximum flow rate (Qmax) and mean average flow rate (Qavg). Prostate volume and residual urine volume showed a significant improvement in both the treatment groups at 12 weeks. However, the intergroup differences in IPSS, uroflowmetry and USG parameters were not significant. Both treatments were well tolerated.Conclusions: The current study established that both the drug combinations i.e. silodosin and dutasteride (SD) and alfuzosin and dutasteride (AD) largely have a comparable effect on both the dynamic and static components of BPH. Further, both drug combinations appear to have a comparable safety profile.