PMID- 19626818 OWN - NLM STAT- MEDLINE DCOM- 20090814 LR - 20131121 IS - 0125-2208 (Print) IS - 0125-2208 (Linking) VI - 92 IP - 7 DP - 2009 Jul TI - 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. PG - 969-78 AB - 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. FAU - Kongkanand, Apichat AU - Kongkanand A AD - King Chulalongkorn Memorial Hospital, Bangkok 10330, Thailand. FAU - Chodchoy, Viroj AU - Chodchoy V FAU - Lojanapiwat, Bannakij AU - Lojanapiwat B FAU - Pumpaisanchai, Somkiat AU - Pumpaisanchai S FAU - Ratana-Olarn, Krisada AU - Ratana-Olarn K FAU - Sae-Tang, Pat AU - Sae-Tang P FAU - Taweemonkongsap, Tawatchai AU - Taweemonkongsap T LA - eng PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - Thailand TA - J Med Assoc Thai JT - Journal of the Medical Association of Thailand = Chotmaihet thangphaet JID - 7507216 RN - 0 (Adrenergic alpha-Antagonists) RN - 0 (Delayed-Action Preparations) RN - 0 (Quinazolines) RN - 90347YTW5F (alfuzosin) SB - IM MH - Adrenergic alpha-Antagonists/*administration & dosage MH - Adult MH - Aged MH - Aged, 80 and over MH - Delayed-Action Preparations MH - Ejaculation/drug effects MH - Humans MH - Male MH - Middle Aged MH - Penile Erection/drug effects MH - Prostatic Hyperplasia/complications/diagnosis MH - Quinazolines/*administration & dosage MH - Urinary Retention/*drug therapy/etiology/prevention & control EDAT- 2009/07/25 09:00 MHDA- 2009/08/15 09:00 CRDT- 2009/07/25 09:00 PHST- 2009/07/25 09:00 [entrez] PHST- 2009/07/25 09:00 [pubmed] PHST- 2009/08/15 09:00 [medline] PST - ppublish SO - J Med Assoc Thai. 2009 Jul;92(7):969-78.