title: Effectiveness and safety of silodosin in the treatment of lower urinary tract symptoms in patients with benign prostatic hyperplasia: A European phase IV clinical study (SiRE study).
abstract: To assess the benefit-risk balance of silodosin in a real-life setting of benign prostatic hyperplasia patients with lower urinary tract symptoms.
  
  
  
  A phase IV trial including men aged ≥60 years with a clinical diagnosis of benign prostatic hyperplasia with an International Prostate Symptom Score ≥12 was carried out. Patients received silodosin 8 mg for 24 weeks. The primary end-point was a decrease ≥25% in the total International Prostate Symptom Score. Secondary end-points were: changes in total, storage and voiding, and quality of life International Prostate Symptom Scores; changes in the International Continence Society-male questionnaire; changes in the frequency/volume chart; and satisfaction according to the Patient Perception of Study Medication questionnaire. Treatment-emergent adverse events were recorded.
  
  
  
  Overall, 1036 patients were enrolled. Of these, 766 patients (77.1%) had a decrease ≥25% in the total International Prostate Symptom Score. The mean total International Prostate Symptom Score, and storage and voiding symptoms subscores decreased from 18.9, 8.1 and 10.8 to 10.6, 4.9 and 5.7. Nocturia decreased from 85.7% to 52.4%. The mean International Prostate Symptom Score quality of life score decreased from 4.0 to 2.2. Half of the patients reported an improvement in the frequency and bothersomeness of the most frequent symptoms reported at baseline (all P < 0.001). A reduction in the number of voids was documented by the frequency/volume chart data. The most common treatment-emergent adverse event was ejaculation failure (185 patients; 17.9%), which led to study discontinuation in 2.4% of patients. Overall, 74.2% of patients were satisfied with the medication.
  
  
  
  Silodosin improved lower urinary tract symptoms in three out of four patients, including diurnal voiding and storage symptoms, nocturia, and quality of life. This treatment showed a favorable safety profile in this setting.
authors.affiliation: Unit of Urology, Division of Oncology, Urological Research Institute, IRCSS Ospedale San Raffaele, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Montorsi
authors.affiliation: Unit of Urology, Division of Oncology, Urological Research Institute, IRCSS Ospedale San Raffaele, Milan, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: Gandaglia
authors.affiliation: Department of Urology, Royal Hallamshire Hospital, Sheffield Teaching Hospital NHS Foundation Trust, Sheffield, UK.
authors.forename: Christopher
authors.initials: C
authors.lastname: Chapple
authors.affiliation: Department of Urology, Hospital de São João, Porto, Portugal.|Department of Renal, Urologic and Infectious Disease, Faculty of Medicine, University of Porto, Porto, Portugal.
authors.forename: Francisco
authors.initials: F
authors.lastname: Cruz
authors.affiliation: Urology and Transplantation Service, Hôpital Saint-Louis, University Paris 7, Paris, France.
authors.forename: Francois
authors.initials: F
authors.lastname: Desgrandchamps
authors.affiliation: Urology Service, University Hospital Fundación de Alcorcón, Madrid, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Llorente
mesh_terms: D058668:Adrenergic alpha-1 Receptor Antagonists; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D011470:Prostatic Hyperplasia / Q000150:complications*; D011788:Quality of Life; D064804:Urological Agents / Q000627:therapeutic use*
chemical_list: D058668:Adrenergic alpha-1 Receptor Antagonists; D007211:Indoles; D064804:Urological Agents; C095285:silodosin
keywords: benign prostatic hyperplasia; efficacy; lower urinary tract symptoms; side-effects; silodosin