Comparative Efficacy and Safety Profile of Silodosin 4 vs 8 mg Once Daily Usage in Patients with BPH related LUTS Divided into Subgroups According to IPSS Severity

Abstract Background The purpose of this study was to compare once daily (QD) usage of silodosin 4 and 8 mg in patients divided as those with moderate and with severe LUTS according to IPSS categories in terms of effectiveness and adverse events. Methods A total of 234 patients aged> 40 years were evaluated prospectively. All participants were divided firstly into two groups according to their IPSS severity as moderate and severe. They were further allocated to receive silodosin 4mg and silodosin 8mg QD. Demographic features and laboratory tests were recorded. The patients were questioned with IIEF-5 and IPSS along with QoL index. Uroflowmetric measurements were applied to the patients. All tests and measurements were repeated at the 3rd month and changes from pre-treatment to post-treatment were analyzed by SPSS. Statistical significance level was set at p Results Both treatments provided benefit in patients with both moderate and severe LUTS. While results did not differ among silodosin 4mg and 8mg in patients with moderate LUTS, silodosin 8mg was significantly better than 4mg in those with severe LUTS in terms of improvement of the total IPSS, IPSS voiding subtotal score and QoL score (p=0.015, 0.030, Conclusion Our study revealed that silodosin 4mg QD was as effective as silodosin 8 mg QD in patients with moderate LUTS, but not with severe LUTS. It can be inferred from this study that prescription of silodosin 4 and 8 mg may be chosen to treat the patients with moderate and severe LUTS due to BPH, respectively.