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Individual patient data from registrational trials of silodosin in the treatment of non-neurogenic male lower urinary tract symptoms associated with benign prostatic enlargement: Subgroup analyses of efficacy and safety data - Abstract

OBJECTIVE: To evaluate efficacy and safety of silodosin in a pooled analysis of individual patient data from three registrational RCTs comparing silodosin and placebo in patients with lower urinary tract symptoms (LUTS).

PATIENTS AND METHODS: A pooled analysis of 1494 patients from three 12-week, multicentre, double-blind, placebo-controlled phase III RCTs was performed. Efficacy and safety data were assessed across patients with different baseline characteristics. Statistical analyses were performed with SAS software v.9.3.

RESULTS: Silodosin was significantly more effective than placebo in improving all IPSS-related parameters, and Qmax (p< 0.0414) regardless of patients age. Comparing the efficacy of silodosin in the different age groups, no difference were observed for all the IPSS-related parameters, whereas Qmax improvement was slightly higher in < 65 yr old patients (p=0.0089). Silodosin was significantly more effective than placebo in reducing all IPSS-related parameters regardless of baseline IPSS (p≤ 0.0011). Similarly, silodosin was more effective than placebo in improving IPSS-related parameters regardless of baseline Qmax (p≤ 0.0197). Silodosin was associated with significantly higher adverse event (AE) rates, compared with placebo, in all patients subgroups, with retrograde ejaculation being the most common. Prevalence of dizziness, orthostatic hypotension, and discontinuation rate was similar with silodosin and placebo in most patients subgroups.

CONCLUSIONS: We analyzed efficacy and safety of silodosin in several patients subgroups, demonstrating silodosin was more effective than placebo in improving all the IPSS-related parameters in all patients subgroups, whereas AEs were similar. Notably, cardiovascular AEs were not higher in patients taking antihypertensive drugs or with mild renal function impairment. Discontinuation rates due to AEs were lower in elderly patients.

Written by:
Novara G, Chapple CR, Montorsi F.   Are you the author?
Department of Oncological, Surgical, and Gastroenterological Sciences, Urology Clinic, University of Padua, Padua, Italy.

Reference: BJU Int. 2014 Aug 18. Epub ahead of print.
doi: 10.1111/bju.12906


PubMed Abstract
PMID: 25130493

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