Evaluation of Efficacy and Safety of Silodosin in Comparison to Tamsulosin in Patients with Benign Prostatic Hyperplasia-A Randomized Open-label Study

Background: Benign Prostatic Hyperplasia (BPH) is one of the most common conditions affecting quality of life in older men through bothersome lower urinary tract symptoms (LUTS). Selective α1‐adrenergic antagonists are now first‐line drugs in the medical management of BPH. Because of their greater uroselectivity and minimal hemodynamic effects, tamsulosin and silodosin are generally preferred in the symptomatic therapy of BPH. Objective: To compare the efficacy and safety of Silodosin in comparison to Tamsulosin in symptomatic benign hyperplasia of prostate (BPH). Materials and Methods: A comparative randomized open‐label trial of 6 month duration was conducted on patients attending the Surgery out‐patient department of ASCOMS & H, Sidhra, Jammu. Patients were registered after taking written informed consent and were enrolled in the study after fulfilling the inclusion and exclusion criteria. Patients were randomized to two groups to receive either tamsulosin 0.4 mg controlled release capsule or silodosin 8 mg once daily capsule after dinner for 12 weeks. The treatment response was monitored at 2, 4, and 12 weeks. Uroflowmetric parameters and American Urological Association Symptom Score (AUASS) were recorded at 2, 4 and 12 weeks, whereas ultrasound was reassessed only at 12 weeks. Vital signs (Pulse and Blood Pressure) and treatment emergent adverse events were recorded at all the visits. Results: The study was conducted on a total of 44 patients, 22 patients in tamsulosin group (Group I) and 22 patients in silodosin group (Group II). Final AUA SS at 12‐week was significantly less than baseline for both groups p<0.05).However, groups remained comparable in terms of AUASS at all visits. A statistically significant improvement in Maximum flow rate (Qmax) was seen with tamsulosin and sildosin from baseline at 12 weeks (p<0.05).However, the intergroup differences in Qmax were not statistically significant (p>0.05). Prostate volume however, did not change in either of the groups as well as in intergroup comparison (p>0.05). Both treatments were well‐tolerated. The commonest adverse drug effects encountered in the silodosin group was Dyspepsia and Abnormal ejaculation whereas Headache and postural hypotension were more commonly seen in the tamsulosin group. However, when both the groups were compared, the difference between the two was observed to be non‐significant (p>0.05). Conclusion: Tamsulosin and silodosin showed similar efficacy in symptomatic management of BPH with good tolerability, acceptability, and minimum hemodynamic adverse effects.