OBJECTIVE - To assess the benefit-risk balance of silodosin in a real-life setting of benign prostatic hyperplasia patients with lower urinary tract symptoms.
METHODS - 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.
RESULTS - 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.
CONCLUSIONS - 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.
International journal of urology : official journal of the Japanese Urological Association. 2016 Mar 11 [Epub ahead of print]
Francesco Montorsi, Giorgio Gandaglia, Christopher Chapple, Francisco Cruz, Francois Desgrandchamps, Carlos Llorente
Unit of Urology, Division of Oncology, Urological Research Institute, IRCSS Ospedale San Raffaele, Milan, Italy., Unit of Urology, Division of Oncology, Urological Research Institute, IRCSS Ospedale San Raffaele, Milan, Italy., Department of Urology, Royal Hallamshire Hospital, Sheffield Teaching Hospital NHS Foundation Trust, Sheffield, UK., Department of Urology, Hospital de São João, Porto, Portugal., Urology and Transplantation Service, Hôpital Saint-Louis, University Paris 7, Paris, France., Urology Service, University Hospital Fundación de Alcorcón, Madrid, Spain.