THE EVALUATION OF EFFICACY AND SAFETY OF TREATMENT WITH DALFAZ SR IN PATIENTS WITH PROSTATIC ADENOMA
- Authors: Rasner P.I1, Yu Pushkar D.Y.1
-
Affiliations:
- Issue: No 3 (2013)
- Pages: 34-38
- Section: Articles
- URL: https://journals.eco-vector.com/1728-2985/article/view/279837
- ID: 279837
Cite item
Open Access
Access granted
Abstract
An open non-comparative multicenter study-observation according the program involving 190 patients (mean age - 62,3 ± 9,7 years) with benign prostatic hyperplasia (BPH) and severe urination disorders was performed. All of the patients received alfuzosin (dalfaz SR) 10 mg daily for 12 months. The primary criterion for evaluation of treatment effectiveness was the change of the total IPSS score. As secondary criteria, change of QoL score, total number of urination per day and subjective patient’s satisfaction with the treatment results were registered. Safety was assessed by recording the adverse events. The treatment led to the progressive decrease in the total IPSS score - from 16,4 ± 4,8 at baseline to 7,7 ± 2,6 at the final visit (P <0,001). The average QoL score has decreased by 67% - from 3,9 ± 1,1 to 1,3 ± 0,7 at the end of the study (P <0,001). In general, 94.2% of respondents positively assessed the results of treatment. The frequency of urination at night has decreased by 56%. Adverse effects (dizziness and slight fatigue) were recorded only in 1 (0,5%) patient. The present study has demonstrated a high efficacy and a favorable safety profile of dalfaz SR at a dose of 10 mg in the treatment of patients with BPH. Of particular note is the high proportion of patients who continued to receive the drug for 12 months, showing a good tolerability of dalfaz SR and high treatment compliance.
Full Text
References
- Аляев Ю.Г., Григорян В.А., Чалый М.Е. Нарушение половой и репродуктивной функции у мужчин. М., Литтерра, 2006. 188 с.
- Oishi k., Boyle P. et al. Epidemiology and natural history of benign prostatic hyperplasia. Fourth International Consultation on Benign Prostatic Hyperplasia (BPH), Paris 2-5 July 1997, edited by Denis L. et al. 1998, 25-59.
- Nakagawa H., Niu K., Hozawa A. et al. Association between nocturia and mortality in a community-dwelling eldery population aged 70 year sand over: results of a 3-year prospective cohort study in Japan. J Urology. 2009;181(4) Suppl. abstr. 20.
- Oelke M., Bachmann A., Descazeaud A. et al. Guidelines on Management of Male Lower Urinary Tract Symptoms (LUTS), incl. Benign Prostatic Obstruction (BPO). European Association of Urology 2012.
- Hutchison A., Farmer R., Verhamme K. et al. The efficacy of drugs for the treatment of LUTS/BPH, a study in 6 europeancountries. Eur. Urol. 2007;51:207-216.
- Lefevre-Borg F., O’Connor S.E. et al. Alfuzosin, a selective a1-adrenoceptor antagonist in the lowerurinarytract. Br. J. Pharmacol. 1993;109:1282-1989.
- Jardin A., Bensadoun H. et al. Alfuzosin for treatment of benign prostatic hypertrophy. Lancet 1991;337:1457-1460.
- Marks L.S., Roehrborn C. G. et al. First dose efficacy of alfuzosinon cedaily in men with symptomatic benign prostatic hyperplasia. Urology, 2003;62:888-893.
- Roehrborn C. Alfuzosin 10 mg once daily prevents overall clinical progression of benign prostatic hyperplasia but not acute urinary retention: results of a 2-year placebo-controlled study. BJU Int 2006 ;97:734-741.
- Vallancien G., Emberton M., Alcaraz F. et al. Alfuzosin 10 mg once daily for treating benign prostatic hyperplasia: a 3-year experience in real-life practice. BJU 2008;101:847-852.
- Elhilali M., Emberton M., Matzkin H. et al, for the ALF-ONE Study Group. 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.
- Lukacs B., Grange J.C. et al. Three-year prospective study in 3228 clinical BPH patients treated with alfuzosin in general practice. Prostate Cancer and Prostatic Diseases, 1998;5:276-283.
- van Kerrebroec P., Jardin A., van Cangh P., Laval K.U; ALFORTI Study Group. Long-term safety and efficacy of a once-daily formulation of alfuzosin 10 mg in patients with symptomatic benign prostatic hyperplasia: open-label extension study. Eur. Urol. 2002;41:54-60.
- Roehrborn C. G., Van Kerrebroeck P., Nordling J. Safety 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.
Supplementary files
