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 hyp
erplasia (BPH) from 812 centers were included in a prospective 3-year
open-labeled study and treated with alfuzosin (immediate-release formu
lation) at the recommended dosage. Symptom score (Boyarsky, modified)
and a 20-item BPH-specific health related quality of life (HRQL) score
(Urolife(TM) BPH QoL 20), which included three questions on sexuality
, were self-administered at baseline, 3, 6, 12, 18, 24, 30 and 36 mont
hs. Symptom score was significantly reduced by 54% at 3 months and thi
s reduction was maintained up to 36 months; the HRQL score was signifi
cantly improved by 45.4% at 12 months and this improvement was also ma
intained up to 36 months. Alfuzosin was well tolerated: the quantitati
ve and qualitative distribution of adverse events (AEs) was similar to
that previously observed in placebo-controlled studies. 4.2% of the p
atients dropped out due to AEs. This study confirms the long-term safe
ty profile of alfuzosin in general practice and highlights the need to
measure HRQL in the context of clinical uroselectivity.