Korean J Urol.  2009 Apr;50(4):333-339.

Efficacy and Safety of Alfuzosin 10 mg Once Daily in Patients with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia: A 6-Months Study in Real Life Practice

• Lee SW
• Lee SH
• Oh CY
• Chung BH

Abstract

PURPOSE
The aim of the study was to evaluate the long-term safety profile and efficacy of Alfuzosin 10 mg once daily in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH), under daily practice conditions in Korea. MATERIALS AND METHODS: In this 6-months, open-label, multicenter, noncomparative, observational study, 511 men were enrolled. International Prostate Symptom Score (IPSS), IPSS 8th question (bother score), maximum flow rate (Qmax), Danish Prostate Symptom Score (DAN-PSS) were evaluated at baseline and after 3, 6 months of treatment. Safety was analyzed in all patients exposed to alfuzosin (n=480). Analysis was performed at end-point in the intent to treat population (n=368). RESULTS: Of the 511 enrolled patients in the study, 218 patients (42.7%) dropped out. With alfuzosin, IPSS and bother score significantly improved from baseline by -6.7+/-6.4 (-31.9%, p<0.001) and -1.2+/-1.2 (-29.3%, p<0.001), respectively. Nocturia also significantly improved from 2.3+/-1.3 at baseline to 1.8+/-1.0 at end-point (-0.6+/-1.1, p<0.001). In the subgroup of patients likely to be obstructed (Qmax <10 ml/sec at baseline), Qmax improved from 8.3+/-1.2 at baseline to 13.7+/-6.1 at end-point (+5.4+/-5.8, p=0.001). In patients with pain/discomfort on ejaculation, weighted score significantly improved from 2.4+/-2.2 at baseline to 1.5+/-1.9 at end-point (-31%, p=0.002). There were no clinically relevant changes in sitting systolic BP and diastolic BP at endpoint. CONCLUSIONS: Alfuzosin 10 mg once daily administered for 6-months is effective in improving LUTS and quality of life, and is well tolerated from a sexual and cardiovascular perspective, including in elderly men and those receiving anti-hypertensive co-medication.

Keyword

Prostatic hyperplasia; Alfuzosin

MeSH Terms

Aged
Ejaculation
Humans
Korea
Lower Urinary Tract Symptoms
Male
Nocturia
Prostate
Prostatic Hyperplasia
Quality of Life
Quinazolines
Quinazolines

Figure

• 

  Fig. 1 The improvement of lower urinary tract symptoms (LUTS) following treatment with alfuzosin 10 mg once daily. IPSS: International Prostate Symptom Score (observed case at each visit). a: p<0.001 vs. baseline, b: p<0.05 vs. M3.

• 

  Fig. 2 The improvement of weighted score following treatment with alfuzosin 10 mg once daily. DAN-PSS weighted item: Danish Prostate Symptom Score (observed case at each visit). a: p<0.05 vs. baseline, b: p<0.05 vs. M3.

• 

  Fig. 3 Comparison of changes in blood pressure by sub-groups. a: p>0.05 vs. baseline, b: p>0.05 vs. not treated group, c: p>0.05 vs. ≥65 years old group.

Reference

1. Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age. J Urol. 1984. 132:474–479.

2. Han KS, Hong SJ, Chung BH. Changing trends in the management of benign prostatic hyperplasia during recent 5 years. Korean J Urol. 2005. 46:458–462.

3. van Kerrebroeck P, Jardin A, Laval KU, van Cangh P. Efficacy and safty of a new prolonged release formulation of alfuzosin 10 mg once daily versus alfuzosin 2.5 mg thrice daily and placebo in patients with symptomatic benign prostatic-hyperplasia. Eur Urol. 2000. 37:306–313.

4. Roehrborn CG. Efficacy and safty of once-daily alfuzosin in the treatment of lower urinary tract symptoms and clinical benign prostatic hyperplasia: a randomized, placebo-controlled trial. Urology. 2001. 58:953–959.

5. Roehrborn CG, Van Kerrebroeck P, Nordling J. Safty and efficacy of alfuzosin 10 mg once-daily in the treatment of lower urinary tract symptoms and clinical benign prostatic hyperplasia: a pooled analysis of three double-blind, placebo-controlled studies. BJU Int. 2003. 92:257–261.

6. Nordling J. Efficacy and safty of two doses (10 and 15 mg) of alfuzosin or tamsulosin (0.4 mg) once daily for treating symptomatic benign prostatic hyperplasia. BJU Int. 2005. 95:1006–1012.

7. Joung JY, Park JK, Park CH, Lee JG, Chung BH, Hong SJ, et al. The role of alpha 1(A) adrenoceptor antagonist tamsulosin for the treatment of patients with benign prostatic hyperplasia: the effect on lower urinary tract symptoms and nocturia. Korean J Urol. 2006. 47:1–6.

8. Nickel JC, Elhilali M, Emberton M, Vallancien G. The beneficial effect of alfuzosin 10 mg once daily in 'real-life' practice on lower urinary tract symptoms (LUTS), quality of life and sexual dysfunction in men with LUTS and painful ejaculation. BJU Int. 2006. 97:1242–1246.

9. Christensen MM, Bruskewitz RC. Clinical manifestations of benign prostatic hyperplasia and indications for therapeutic intervention. Urol Clin North Am. 1990. 17:509–516.

10. Dorflinger T, England DM, Madsen PO, Bruskewitz RC. Urodynamic and histological correlates of benign prostatic hyperplasia. J Urol. 1988. 140:1487–1490.

11. Palea S, Barras M. Comparison of the relxant effects of alfuzosin, phentolamine and sildenafil on rabbit isolated corpus cavernosum. BJU Int. 2003. 91:873–877.

12. Mayoux E, Ramirez JF, Pouyet T, Barras M, Arbilla S, Galzin AM. Alfuzosin improves penile erection triggered by apomorphine in spontaneous hypertensive rats. Eur Urol. 2004. 45:110–116.

13. Vallancien G, Emberton M, Harving N, van Moorselaar RJ. Alf-One Study Group. Sexual dysfunction in 1274 European men suffering from lower urinary tract symptoms. J Urol. 2003. 169:2257–2261.

14. Sak SC, Hussain Z, Johnston C, Eardley I. What is the relationship between male sexual function and lower urinary tract symptoms (LUTS)? Eur Urol. 2004. 46:482–487.

15. Cho YH, Kim DG, Lee KS. Effects of doxazosin on sexual function in patients with benign prostatic hyperplasia. Korean J Urol. 2004. 45:130–134.

16. van Moorselaar RJ, Hartung R, Emberton M, Harving N, Matzkin H, Elhilali M, et al. Alfuzosin 10 mg once daily improves sexual function in men with lower urinary tract symptoms and concomitant sexual dysfunction. BJU Int. 2005. 95:603–608.

17. Elhilali M, Emberton M, Matzkin H, van Moorselaar RJ, Hartung R, Harving N, et al. Long-term efficacy and safety of alfuzosin 10 mg once daily: a 2-year experience in 'real-life' practice. BJU Int. 2006. 97:513–519.

18. Chung BH, Park EK, Hong SJ. The efficacy and safty of doxazosin GITS in patients with benign prostatic hyperplasia. Korean J Urol. 2004. 45:667–673.

19. Chung BH, Kim YS, Hong SJ. 12-month follow-up study to evaluate the efficacy and safty of doxazosin GITS in patients with benign prostatic hyperplasia. Korean J Urol. 2005. 46:451–457.

20. Schulman CC, Cortvriend J, Jonas U, Lock TM, Vaage S, Speakman MJ. Tamsulosin: 3-year long-term efficacy and safty in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction: analysis of a European, multinational, multicenter, open-label stydy. European Tamsulosin Study Group. Eur Urol. 1999. 36:609–620.

21. Bourke JB, Griffin JP. Hypertension, diabetes mellitus, and blood groups in benign prostatic hypertrophy. Br J Urol. 1966. 38:18–23.

22. Hartung R, Matzkin H, Alcaraz A, Emberton M, Harving N, van Moorselaar J, et al. Age, comorbidity and hypertensive co-medication do not affect cardiovascular tolerability of 10mg alfuzosin once daily. J Urol. 2006. 175:624–628.

23. Mottet N, Bressolle F, Delmas V, Robert M, Costa P. Prostatic tissual distribution of alfuzosin in patients with benign prostatic hyperplasia following repeated oral administration. Eur Urol. 2003. 44:101–105.