EFFICACY AND SAFETY OF FIXED DOSE COMBINATIONS (FDC’S) OF TAMSULOSIN AND SILODOSIN WITH DUTASTERIDE IN PATIENTS OF LOWER URINARY TRACT SYMPTOMS (LUTS) WITH BENIGN PROSTATIC HYPERPLASIA (BPH): A RANDOMISED CLINICAL STUDY

M. C. Gupta, Nishant Madan* and Hemant Kamal

ABSTRACT

Background: α-1 blockers, which improves dynamic component, and 5α-reductase inhibitors (5ARIs), which halt the progression of disease, have been rationally used as FDC’s in patients of LUTS with BPH. This study compared efficacy and safety of FDC’s of tamsulosin and silodosin with dutasteride. Methods: Sixty-four patients were randomized to receive once daily FDC’s of tamsulosin with dutasteride (Group 1) and silodosin with dutasteride (Group 2) over 16 weeks. Primary efficacy outcome measures were change in International prostate symptom score (IPSS) and uroflowmetry parameters. Secondary efficacy outcome measures were change in prostatic and post-void residual urine volume determined ultrasonographically. Safety was evaluated by using standard adverse drug reaction (ADR) reporting form of CDSCO. Results: IPSS improved in both group 1 and 2 by 48.6% and 49.13% respectively at 16 weeks (p <0.001). Maximum urinary flow rate (Qmax) improved by 2.42 ml/sec & 2.27 ml/sec in group 1 and 2 respectively at 16 weeks (p value <0.001). Other uroflowmetry parameter also improved significantly in both the groups equally except time to maximum flow (TQmax) which was better with tamsulosin combination. Prostate volume reduced significantly by 13.18% and 10.96% and post-void residual urine volume reduced significantly by 58.49% and 54.27% in group 1 and 2 respectively. Both FDCs had a comparable ADR profile mainly retrograde ejaculation and dizziness. Conclusion: FDC’s of tamsulosin and silodosin with dutasteride are equally effective and safe medical therapy for LUTS with BPH and can be used as per physician preference.

Keywords: Tamsulosin, Silodosin, Dutasteride, Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia.