European Journal of Biomedical and Pharmaceutical Sciences

HALPHABAROL THERAPY IN EGYPTIAN PATIENTS WITH CIRRHOSIS AND DIURETIC-RESISTANT ASCITES

Ahmed M. Ali*, BSc. Pharm, PhD and Kamal A. Ramzy, MD, MMed

ABSTRACT

Background: Liver cirrhosis accounts for over 75% of all episodes of ascites. One of the most serious complications in cirrhotic patients with ascites is the occurrence of refractoriness that is the inability to resolve ascites by the standard diuretic therapy. Diuretic–resistant ascites is defined as failure to respond to maximal tolerated doses of spironolactone and frusemide. At this point, the need for serial therapeutic paracentesis (abdominal tapping) becomes a must. Objectives: The aim of this study is to evaluate the diuretic effects of halphabarol and its possible role in the mobilization and control of ascites in cirrhotic ascitic patients resistant to maximal tolerated doses of standard diuretic therapy (SDT). Patients and methods: A total of 44 cirrhotic patients with diuretic-resistant ascites were prospectively studied after 1 month administration of SDT alone (n = 22) or in combination with halphabarol (n = 23) in a randomized controlled open-label pilot study. Results: Significant increases in 24-h urinary output, urinary sodium excretion, random urinary sodium/potassium ratio and significant reductions in body weight, abdominal girth, plasma renin activity and plasma aldosterone concentration (P < 0.05) were noted after 1 month in the halphabarol group. Furthermore, the effective diuretic doses and the need for large-volume paracentesis were significantly reduced in the halphabarol group compared to the SDT group after 1 month of therapy. No significant changes in the aforementioned parameters were noted in the SDT group. There were no significant changes in the scores of end-stage liver disease in both groups. Conclusions: These results suggest that the addition of halphabarol to SDT improves enhances water and sodium excretion, providing better control in cirrhotic ascitic patients resistant to SDT.

Keywords: Diuretic-resistant ascites, halphabarol, plasma renin activity, plasma aldosterone concentration, abdominal girth.