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
Apichat Kongkanand MD*, Viroj Chodchoy MD**, Bannakij Lojanapiwat MD***, Somkiat Pumpaisanchai MD****, Krisada Ratana-Olarn MD*****, Pat Sae-Tang MD******, Tawatchai Taweemonkongsap MD*******
Affiliation : * King Chulalongkorn Memorial Hospital, Bangkok, Thailand ** Bumrungrad International Hospital, Bangkok, Thailand *** Maharaj Nakorn Chiang Mai Hospital, Chiang Mai, Thailand **** Rajvithi Hospital, Bangkok, Thailand ***** Ramathibodi Hospital, Bangkok, Thailand ****** Bangkok Metropolitan Administration Medical College and Vajira Hospital, Bangkok, Thailand ******* Siriraj Hospital, Bangkok, Thailand
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
