Efficacy and safety of brand-to-generic Tamsulosin for treating lower urinary tract symptoms associated with benign prostatic hyperplasia; A randomized, non-inferiority study
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Abstract
Objective: To compare the efficacy and safety of Uroflow (Mega, Thailand) and Harnal (Astellas Pharma, Thailand) for treating lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH)
Methods: This is a randomized, non-inferiority study in 180 patients who have Lower Urinary Tract Symptoms (LUTS) and International Prostatic Symptom Score (IPSS) more than 7. We randomly assigned patients to receive either Uroflow or Harnal for 12 weeks. All data was collected at baseline, the 4th week and the 12th weeks. The primary outcome was the mean change in IPSS from baseline to the endpoint. Secondary outcomes were the mean change in IPSS subscore, Qaulity of Life (QoL), maximum uroflowmetry (Qmax), Post Voiding Residuals (PVR) and adverse event of tamsulosin.
Results: 180 patients were randomly assigned into two groups (90 Uroflow, 90 Harnal). The mean changes in IPSS from baseline in Uroflow and Harnal-treated groups were -8.81±6.92 and -8.47±5.91, respectively. There was a statistically significant improvement in both groups. The mean difference (Uroflow- Harnal) was 0.34 (with a two-side 90% confidence interval), inferring that Uroflow was not inferior to Harnal. The mean change in IPSS subscore, QoL, Qmax, PVR were comparable between both groups. The incidence of adverse event were not significantly different.
Conclusions: The results of this study show that Uroflow is not inferior to Harnal in the treatment of patients with LUTS associated with BPH.
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References
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