Session Title: Category 2b. CIRRHOSIS AND ITS COMPLICATIONS: b. CLINICAL ASPECTS
Presentation Date: Apr 15, 2010
THERAPEUTIC EFFICACY OF L-ORNITHINE-L-ASPARTATE INFUSIONS IN PATIENTS WITH CIRRHOSIS AND HEPATIC ENCEPHALOPATHY
N. Oruc1*, A. Ozturk1, I.K. Onal2, N.G. Unal1, M. Akdogan2, C. Yurdaydin3, Z. Karasu1, O. Ozutemiz1
1Gastroenterology, Ege University Faculty of Medicine, Izmir, 2Gastroenterology, Yuksek Ihtisas Training Hospital, 3Gastroenterology, Ankara University, Faculty of Medicine, Ankara, Turkey. *firstname.lastname@example.org
Introduction: Experimental and clinical studies suggest that L-Ornithine-L-Aspartate( LOLA) may have a favorable influence on hepatic encephalopathy (HE) due to the effect on the reduction of ammonia, and improvement of the symptoms.
Aim: To evaluate the efficacy of LOLA when compared to placebo in the treatment of hepatic encephalopathy.
Methods: Sixtynine patients who addmitted to intensive care unit with cirrhosis and overt HE were evaluated. Patients with Wilson disease, metabolic liver disorders, acute liver failure, HCC, hepatorenal syndrome, alcohol addiction, systemic and neurological disorders were excluded from the study. Totally 47 patients were enrolled in a randomized, placebo-controlled clinical trial of intravenously administered LOLA. LOLA administered in a dose of 40 g/d, as well as placebo, were dissolved in 5% glucose and infused intravenously for a period of 8hrs during 5 consecutive days. Necessary interventions or drugs including antibiotics and oral lactulose were also used in all patients. Primary variables were mental state gradation, fasting blood ammonia levels, and critical flicker frequency (CFF) performance which were estimated twice daily.
Results: During baseline, the placebo and treatment groups were homogeneous with regard to age, BMI, mental states, CFF performance time, fasting blood ammonia levels, Child-Pugh and MELD score, and liver function tests. LOLA treatment significantly improved the Glasgow (p< 0.05) and West-Heaven coma grades (p< 0.01) starting at second day. Also fasting ammonia levels were significantly decreased by LOLA starting at third day (192 ±127 vs 126±71 p< 0.05), while placebo did not have such an effect. HE resolved in 3.1±1.2 days in LOLA group and 3.7±1.4 days in plasebo group, p =0.2. HE did not resolve in five days in 16.1% of LOLA and 25% of plasebo group. Mortality rates were also similar between LOLA and placebo groups (6.5% and 12,5% respectively). Adverse events consisting of mild gastrointestinal disturbances were observed in 3 patients of the LOLA groups.
Conclusions: Our results suggest that LOLA may have a favorable influence on HE due to the effect on the reduction of ammonia, and improvement of symptoms and laboratory findings related to HE. However it did not effect HE duration and related mortality rates.