Safety and Efficacy of a Prolonged-Release Formulation of Alfuzosin 10 mg Once Daily in Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia

Objective: Assess safety and efficacy of 10-mg prolonged-release alfuzosin (Xatral® XL) in benign prostatic hyperplasia (BPH) patients with lower urinary tract symptoms (LUTS). Material and Method: A multicenter observational study looking at safety by adverse events (AEs) incidence, efficacy by changes in International Prostate Symptom Score (I-PSS), quality of life index (QOL), sexual function using Danish Prostate Symptom Score (DAN-PSS sex), and flow rates. Patients were allocated to receive alfuzosin (Xatral XL) 10 mg once daily tablet along with a meal for 6 months. Patients were assessed at 3 months and 6 months. Results: In 118 males, 22% had AEs (most common was dizziness). Ten patients discontinued the treatment. Of those patients, five had serious AEs, which only one was related to the study. At month 6, there were improvements from baseline in mean I-PSS (-9.3, p < 0.001), in QOL index (-2.96, p < 0.001), in symptom (-0.72, p < 0.05) and bothersome (-1.13, p < 0.01) subscores on DAN-PSS sex, and in mean flow rate (0.92, p < 0.01). Approximately 74% patients improved within two weeks. There was one case of Acute urinary retention (AUR), which none required surgery. Conclusion: A 10-mg prolonged-release alfuzosin safely and rapidly relieves LUTS and maintains improvement. It also improves BPH-associated sexual dysfunction. Keywords: Adrenergic alpha-antagonists, Prostatic hyperplasia, Safety, Urinary retention, Urologic diseases