title: Individual patient data from registrational trials of silodosin in the treatment of non-neurogenic male lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH): 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 randomised controlled trials (RCTs) comparing silodosin and placebo in patients with lower urinary tract symptoms (LUTS).
  
  
  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.
  
  
  RESULTS
  Silodosin was significantly more effective than placebo in improving all International Prostate Symptom Score (IPSS)-related parameters, and maximum urinary flow rate (Qmax ) regardless of patients age (P < 0.041). Comparing the efficacy of silodosin in the different age groups, there were no differences for all the IPSS-related parameters, whereas Qmax improvement was slightly higher in patients aged <65 years (P = 0.009). Silodosin was significantly more effective than placebo in reducing all IPSS-related parameters regardless of baseline IPSS (P ≤ 0.001). Similarly, silodosin was more effective than placebo in improving IPSS-related parameters regardless of baseline Qmax (P ≤ 0.02). Silodosin was associated with significantly higher adverse event (AE) rates, compared with placebo, in all patient subgroups, with retrograde ejaculation being the most common. Prevalence of dizziness, orthostatic hypotension, and discontinuation rate was similar with silodosin and placebo in most patient subgroups.
  
  
  CONCLUSIONS
  We analysed the efficacy and safety of silodosin in several patient subgroups, showing that silodosin was more effective than placebo in improving all IPSS-related parameters in all patient 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.
authors.affiliation: Department of Oncological, Surgical, and Gastroenterological Sciences, Urology Clinic, University of Padua, Padua, Italy.
authors.forename: Giacomo
authors.initials: G
authors.lastname: Novara
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Chapple
authors.forename: Francesco
authors.initials: F
authors.lastname: Montorsi
mesh_terms: D058668:Adrenergic alpha-1 Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003627:Data Interpretation, Statistical; D004311:Double-Blind Method; D006801:Humans; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011470:Prostatic Hyperplasia / Q000150:complications; D016032:Randomized Controlled Trials as Topic; D012042:Registries
chemical_list: D058668:Adrenergic alpha-1 Receptor Antagonists; D007211:Indoles; C095285:silodosin
keywords: benign prostatic hyperplasia (BPH); lower urinary tract symptoms (LUTS); silodosin; α-blockers