Safety, efficacy and impact on patients' quality of life of a long-term treatment with the alpha(1)-blocker alfuzosin in symptomatic patients with BPH

Objective: The aim of this study was to assess the impact of a 12-month tre atment period with alfuzosin, 2.5 mg t.i.d, on symptomatic patients with BP H (n = 355) by means of the International Prostate Symptom Score (I-PSS), t he Symptom Problem Index (SPI), the BPH impact Index (BII), and the single Quality of Life (QoL) question proposed by the WHO. Study Design: This was a naturalistic study, carried out under conditions o f normal practice by 22 centres of urology. Methods: At baseline and on a quarterly basis up to 12 months of treatment, subjective and objective (uroflowmetry and residual urine volume) response s of the patients were evaluated. The appearance of adverse medical events (AMEs) was carefully monitored and recorded throughout the trial. Results: Both the BII and the Qol question improved gradually over time (60 and 54.6%, respectively, after 12 months of treatment). At any visits, the improvements were statistically significant versus the baseline (p<0.01). Alfuzosin was able to improve the BPH symptoms progressively and significan tly over time: total mean score I-PSS: 3rd month = 22.7%, 6th month = 38.4% , 9th month 0.50%, 12th month = 61.6%. The improvement was more marked in p atients with severe symptoms at baseline (I-PSS score 20-35, 63.6%). A prog ressive and marked improvement over time of the problems due to symptoms (S PI) was observed in the whole population (62.7% after 12 months of treatmen t). After 12 months of treatment, uroflowmetric data showed a significant i ncrease in peak (+5.5 ml/s) flow rate, associated with a marked decrease in residual volume: -31 ml (-53.5%). Twenty-five patients (7.1%) experienced one or more AMEs (total AMEs n = 44). Globally, 14 vasodilatory events and 30 non-vasodilatory events were reported. Fifteen (4.3%) patients dropped o ut prematurely from the study for safety reasons. Seven serious AMEs were r eported during the study period. Conclusions: This study showed that long-term treatment with alfuzosin in u sual clinical practice had a continued and positive impact on the patients' QoL. copyright (C) 2000 S. Karger AG, Basel.