Efficacy and Safety of Alfuzosin 10 mg Once Daily in Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: A 6-Months Study in Real Life Practice

ABSTRACT

PURPOSE: The aim of the study was to evaluate the long-term safety profile and efficacy of Alfuzosin 10 mg once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH), under daily practice conditions in Korea. MATERIALS AND METHODS: In this 6-months, open-label, multicenter, noncomparative, observational study, 511 men were enrolled. International Prostate Symptom Score (IPSS), IPSS 8th question (bother score), maximum flow rate (Qmax), Danish Prostate Symptom Score (DAN-PSS) were evaluated at baseline and after 3, 6 months of treatment. Safety was analyzed in all patients exposed to alfuzosin (n=480). Analysis was performed at end-point in the intent to treat population (n=368). RESULTS: Of the 511 enrolled patients in the study, 218 patients (42.7%) dropped out. With alfuzosin, IPSS and bother score significantly improved from baseline by -6.7+/-6.4 (-31.9%, p<0.001) and -1.2+/-1.2 (-29.3%, p<0.001), respectively. Nocturia also significantly improved from 2.3+/-1.3 at baseline to 1.8+/-1.0 at end-point (-0.6+/-1.1, p<0.001). In the subgroup of patients likely to be obstructed (Qmax <10 ml/sec at baseline), Qmax improved from 8.3+/-1.2 at baseline to 13.7+/-6.1 at end-point (+5.4+/-5.8, p=0.001). In patients with pain/discomfort on ejaculation, weighted score significantly improved from 2.4+/-2.2 at baseline to 1.5+/-1.9 at end-point (-31%, p=0.002). There were no clinically relevant changes in sitting systolic BP and diastolic BP at endpoint. CONCLUSIONS: Alfuzosin 10 mg once daily administered for 6-months is effective in improving LUTS and quality of life, and is well tolerated from a sexual and cardiovascular perspective, including in elderly men and those receiving anti-hypertensive co-medication.