Clinical Uroselectivity: A 3-Year Follow-Up in General Practice
- 1 January 1998
- journal article
- clinical trial
- Published by Elsevier in European Urology
- Vol. 33 (Suppl. 2) , 28-33
- https://doi.org/10.1159/000052231
Abstract
The objectives of this open-labeled study were to assess the clinical uroselectivity of alfuzosin in a long-term follow-up study in general practice. A total of 3,228 patients with clinical benign prostatic hyperplasia (BPH) from 812 centers were included in a prospective 3-year open-labeled study and treated with alfuzosin (immediate-release formulation) at the recommended dosage. Symptom score (Boyarsky, modified) and a 20-item BPH-specific health related quality of life (HRQL) score (Urolife BPH QoL 20), which included three questions on sexuality, were self-administered at baseline, 3, 6, 12, 18, 24, 30 and 36 months. Symptom score was significantly reduced by 54% at 3 months and this reduction was maintained up to 36 months; the HRQL score was significantly improved by 45.4% at 12 months and this improvement was also maintained up to 36 months. Alfuzosin was well tolerated: the quantitative and qualitative distribution of adverse events (AEs) was similar to that previously observed in placebo-controlled studies. 4.2% of the patients dropped out due to AEs. This study confirms the long-term safety profile of alfuzosin in general practice and highlights the need to measure HRQL in the context of clinical uroselectivity.Keywords
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