Clinical uroselectivity: a 3-year follow-up in general practice. BPH Group in General Practice.
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.
Lukacs
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B
Urology Department, Hospital Tenon, Paris, France.
Grange
J C
JC
McCarthy
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C
Comet
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D
D000317:Adrenergic alpha-Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000368:Aged; D005194:Family Practice; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D011788:Quality of Life; D011799:Quinazolines / Q000009:adverse effects / Q000627:therapeutic use*; D012449:Safety; D019529:Sexuality / Q000187:drug effects
D000317:Adrenergic alpha-Antagonists; D011799:Quinazolines; C047638:alfuzosin