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. The Italian Alfuzosin Co-Operative Group.

Abstract

The aim of this study was to assess the impact of a 12-month treatment period with alfuzosin, 2.5 mg t.i.d, on symptomatic patients with BPH (n = 355) by means of the International Prostate Symptom Score (I-PSS), the Symptom Problem Index (SPI), the BPH Impact Index (BII), and the single Quality of Life (QoL) question proposed by the WHO. This was a naturalistic study, carried out under conditions of normal practice by 22 centres of urology. At baseline and on a quarterly basis up to 12 months of treatment, subjective and objective (uroflowmetry and residual urine volume) responses of the patients were evaluated. The appearance of adverse medical events (AMEs) was carefully monitored and recorded throughout the trial. 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 significantly 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 patients with severe symptoms at baseline (I-PSS score 20-35, 63.6%). A progressive and marked improvement over time of the problems due to symptoms (SPI) was observed in the whole population (61.7% after 12 months of treatment). After 12 months of treatment, uroflowmetric data showed a significant increase 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 out prematurely from the study for safety reasons. Seven serious AMEs were reported during the study period. This study showed that long-term treatment with alfuzosin in usual clinical practice had a continued and positive impact on the patients' QoL.