Long‐term efficacy and safety of alfuzosin 10 mg once daily: a 2‐year experience in ‘real‐life’ practice

• Published in: BJU international Vol. 97; no. 3; pp. 513 - 519
• Main Authors: ELHILALI, MOSTAFA, EMBERTON, MARK, MATZKIN, HAIM, Van MOORSELAAR, R. JEROEN A., HARTUNG, RUDOLF, HARVING, NIELS, ALCARAZ, ANTONIO, VALLANCIEN, GUY
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.03.2006; Blackwell
• Subjects: Adrenergic alpha-Antagonists - administration & dosage; Adrenergic alpha-Antagonists - adverse effects; Aged; alfuzosin; Biological and medical sciences; Ejaculation - drug effects; Humans; Libido - drug effects; lower urinary tract symptoms; Male; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; Patient Satisfaction; Penile Erection - drug effects; Pharmacology. Drug treatments; Prostatic Hyperplasia - drug therapy; Quality of Life; Quinazolines - administration & dosage; Quinazolines - adverse effects; sexual dysfunction; Treatment Outcome; Urinary Retention - drug therapy; Urinary system; Urinary system involvement in other diseases. Miscellaneous; Urinary tract. Prostate gland; α‐blockers; Human; Nephrology; Urinary system disease; Alfuzosin; Toxicity; Quinazoline derivatives; Sexual dysfunction; Treatment efficiency; α1-Adrenergic receptor; Administration schedule; Urinary tract disease; Long term; Urology; Quality of life; α-blockers; Voiding dysfunction; Chemotherapy; Daily; Alpha blocking agent; Treatment; Complication; Antagonist; Lower urinary tract symptoms
• ISSN: 1464-4096; 1464-410X
• DOI: 10.1111/j.1464-410X.2005.05962.x

OBJECTIVE To assess the 2‐year efficacy and safety of alfuzosin 10 mg once daily, a selective α1‐adrenoceptor antagonist, in men complaining of lower urinary tract symptoms (LUTS) suggestive of benign prostate hyperplasia (BPH), in ‘real life’ practice. PATIENTS AND METHODS In all, 839 European men with LUTS (mean age 67.3 years) were enrolled by general practitioners in a 2‐year open‐label study with alfuzosin 10 mg once daily. They were asked to complete the International Prostate Symptom Score (IPSS), its appended eighth question (bother score), and the five domains (sexual drive, erection, ejaculation, problem assessment, and overall satisfaction) of the Brief Male Sexual Function Inventory (BSFI). The results were analysed at the endpoint in the intent‐to‐treat population. RESULTS At the endpoint the total IPSS improved by 7 points (−38.5%) from baseline (P < 0.001) with 76.9% and 49.7% of men having an improvement of ≥ 3 points and >6 points, respectively. There were also significant improvements in nocturia (−0.9, −30%; P < 0.001) and bother score (−1.8, −43%; P < 0.001) from baseline. Most patients (56%) perceived symptom relief within the first 2 weeks of treatment. All BSFI domains significantly improved from baseline (P < 0.05; <0.001 for overall satisfaction) and these improvements were more marked in men with severe LUTS at baseline. Alfuzosin 10 mg was well tolerated; the most common adverse event related to vasodilatation was dizziness/postural dizziness (3.1%). Ejaculatory disorders were uncommon (0.3%). Changes in blood pressure remained marginal, including in elderly men and those receiving antihypertensive agents. CONCLUSIONS Alfuzosin 10 mg administered for 2 years in real practice is effective in improving LUTS and quality of life, and is well tolerated from a cardiovascular perspective, including in elderly men and those receiving antihypertensive co‐medication. Ejaculatory disorders are uncommon. Alfuzosin may even slightly improve various domains of sexual function, such as sexual drive, erection, ejaculation and satisfaction with sexual life.