One-year follow-up of 2829 patients with moderate to severe lower urinary tract symptoms treated with alfuzosin in general practice according to IPSSand a health-related quality-of-life questionnaire

Objectives. To determine the effectiveness of alfuzosin on symptom reductio n, patients' perceived health-related quality of life (HRQL) improvement, a dverse outcomes, treatment failure, and progression to acute urinary retent ion and prostate surgery in patients with lower urinary tract symptoms sugg estive of benign prostatic hyperplasia (BPH) in a 1-year prospective, open- labeled study. Methods. A total of 2829 patients (mean age 65.9 years) were included in th e study and received either alfuzosin 2.5 mg three times daily or alfuzosin slow release 5 mg twice daily. The evaluation was based on the Internation al Prostate Symptom Score (IPSS), the eighth IPSS question, and a nine-item BPH HRQL questionnaire (BPHQL9) exploring well-being, the patient's percei ved sexual life, and BPH-specific interferences with activities. Results. A total of 2442 patients (86.3%) completed the study; the main rea sons for noncompletion were adverse events (n = 141, 5.0%), lack of efficac y (n = 136, 4.8%), and death (n = 48, 1.7%); 121 patients (4.3%) underwent prostate surgery, and 33 patients (1.2%) experienced acute urinary retentio n. No correlation was found between noncompletion and prostate volume or ba seline severity. The distribution of patients (in percentages) according to the IPSS, IPSS question 8, and BPHQL9 classes of severity (mild/ moderate/ severe) at baseline was 1.9/49.0/49.1, 0.7/65.5/33.8, and 7.7/50.4/41.9, re spectively, and at 1 year was 47.4/50.3/2.4, 34.1/64.9/1.0, and 39.0/50.9/1 0.1, respectively. The IPSS (19.5 +/- 0.1) was reduced by 49.6% (9.9 +/- 0. 1) at 6 months and by 53.8% (11.1 +/- 0.1) at 12 months. Symptom reduction strongly correlated with the initial symptom severity (P <0.0001). The BPHQ L9 score (34.6 +/- 0.3) gradually improved up to 12 months (52 +/- 0.4; +93 .3%), and this improvement involved all three dimensions. Vertigo (n = 53, 1.9%), hypotension (n = 47, 1.6%), and dizziness (n = 16, 0.6%) were the mo st frequent adverse events. Conclusions. This study confirms the effectiveness of alfuzosin and the nee d to include HRQL measurement in the decision-making process when assessing patients with lower urinary tract symptoms. UROLOGY 55: 540-546, 2000. (C) 2000, Elsevier Science Inc.