Safety and Efficacy of Bearxat(R)XL Tablet (alfuzosin 10 mg) in Patients with Benign Prostatic Hyperplasia: A Prospective Multicenter Study of Primary Care Clinics / 대한남성과학회지

ABSTRACT

PURPOSE: A prospective multi-center study was conducted to evaluate the safety and efficacy of alfuzosin (10 mg), for male lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in primary care clinics. MATERIALS AND METHODS: Three hundred twenty-four patients with complaints of LUTS associated with BPH were enrolled from 17 clinics. Patients received a 12-week course of 10 mg alfuzosin (Bearxat(R)XL Tablet) once daily, and underwent follow-up at 2~4 and 12 weeks post-treatment. The maximum flow rate (Qmax) and residual urine volume (RUV) were measured at each visit. The International Prostate Symptom Score (IPSS), Quality of Life (QoL), and International Index of Erectile Function (IIEF-5) were evaluated at baseline and post-treatment. During the study period, the presence of orthostatic hypotension was evaluated by blood pressure measurement before and after a postural change. Any adverse effects of alfuzosin including retrograde ejaculation were assessed. RESULTS: Of the 324 enrolled patients, 62 (19.1%) patients dropped out and a total of 262 patients were evaluated. Each value of Qmax, RUV, IPSS, QoL, and IIEF-5 was significantly improved from 14.19+/-8.85 ml/sec, 41.10+/-81.44 ml, 18.04+/-7.36, 3.81+/-0.86, and 11.75+/-6.91, respectively, at baseline, to 15.68+/-6.25 ml/sec, 24.29+/-29.46 ml, 12.19+/-5.59, 2.54+/-0.91, and 12.33+/-7.55, respectively, at end-point. Retrograde ejaculation was found in 2 patients (2/255, 0.78%) at 2~4 weeks and 1 patient (1/152, 0.66%) at 12 weeks. The frequency of orthostatic hypotension was 13.27% (30/226) at baseline, 13.11% (27/206, p=0.8658) at 2~4 weeks, and 14.29% (19/133, p=0.8348) at end-point. The number of patients with adverse events was 36 where the number of adverse events was 60. Among those 60 adverse events, 8 events were related to treatment, which consisted of headache (2), dizziness (2), palpitation (1), voiding difficulty (1), erectile dysfunction (1), and arthralgia (1). CONCLUSIONS: Treatment with alfuzosin (10 mg) once daily led to significant improvements in LUTS associated with BPH and QoL in primary care clinic patients. alfuzosin (10 mg) use resulted in few hypotensive events, no deleterious effect on sexual function, and no drug related SAEs during the study. The study findings suggest that alfuzosin (10 mg) can be safely prescribed in primary care clinics for male LUTS with efficacy.