Long-term efficacy and safety of alfuzosin 10 mg once daily: a 2-year experience in 'real-life' practice.

OBJECTIVE: To assess the 2-year efficacy and safety of alfuzosin 10 mg once daily, a selective alpha(1)-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 > or = 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.