EFFECT OF ALFUZOSIN ON QUALITY-OF-LIFE IN BENIGN PROSTATIC HYPERPLASIA PATIENTS - PRELIMINARY-RESULTS

Recently urologists have focused their attention not only on classical evaluation parameters for patients suffering from benign prostatic hyperplasia (BPH). such as symptoms and uroflowmetry, but also on the impact of therapy on the patients' quality of life. An observational, open-label, uncontrolled trial was designed to evaluate the impact of a 3-month therapy with alfuzosin (2.5 mg t.i.d.) on the quality of life of patients complaining of BPH-related symptoms for at least 6 months. Nine hundred and ninety patients were enrolled in 86 Italian centers of urology. At baseline and after 84 days of treatment the following assessments were performed: the Maine Medical Assessment Program Symptom Score, a quality of life questionnaire, and at selected centers, uroflowmetry and residual volume measurement. Preliminary results on 498 evaluable patients (who completed the study by March 1992), showed the ability of alfuzosin to improve BPH symptoms significantly (total mean score from 12.02 +/- 0.17 to 7.27 +/- 0.12, -39.5%), mostly in patients with severe symptoms at baseline (-46.8%). All the three indices describing patients' quality of life improved significantly: mental health +2.3% (p < 0.01); general health +4.3% (p < 0.01), and especially, activity +12.9% (p < 0.01). A marked improvement was observed in patients with severe symptoms (activity index +23.8%). Uroflowmetric data obtained from 255 patients showed a significant increase in peak (+4.14 ml/s) and mean (+2.58 ml/s) flows, associated with a marked decrease in residual volume (-34.1 ml. -52.6%). Thirty-three patients experienced one or more adverse medical events, mainly within the first 4 weeks of treatment (20 patients). Twenty-three vasodilatory events (hypotension, n = 9; vertigo/dizziness, n = 6) and 20 nonvasodilatory events (gastrointestinal disturbances, n = 12) were reported, with an incidence of 4.6 and 4.0%. respectively. These preliminary results appear to support the hypothesis of a beneficial effect of pharmacological therapy on the quality of life of BPH patients, particularly those complaining of moderate to severe symptoms. The efficacy of alfuzosin in the treatment of BPH symptoms has been confirmed on both subjective and objective parameters, as has its good safety profile.