P-31 SHORT-TERM EFFICACY AND SAFETY OF LOLA THERAPY IN PATIENTS WITH CIRRHOSIS AND MINIMAL HEPATIC ENCEPHALOPATHY: A REAL-LIFE COHORT STUDY

Introduction and Objectives

Minimal hepatic encephalopathy (MHE) is associated with the risk of accidents, falls, and impaired quality of life. Treatment with L-ornithine L-aspartate (LOLA) could be an effective strategy. This study aimed to verify the efficacy and safety of LOLA treatment in a real-life cohort of cirrhotic patients with MHE.

Materials and Methods

Cirrhotic patients with MHE were included. Those who had received any anti-ammoniacal measure or with alcohol consumption in the last six months, creatinine > 1.5 mg/dL, or previously known chronic kidney disease were excluded. The diagnosis of MHE was made using the psychometric hepatic encephalopathy score (PHES) and the critical flicker frequency (CFF). MHE patients received LOLA 6 g t.i.d. for three days and were reassessed with PHES and CFF. The project was approved by the local research and ethics committees.

Results

98 cirrhotic patients were evaluated; 38 (38.8%) had baseline MHE, 26 (68.4%) women, mean age 53.3±8.8 years, median education nine years (range 0-15). According to Child-Pugh: 26 (68.4%) A, 9 (23.7%) B, and 3 (7.9%) C. The median MELD was 11 (range 6-21), and MELD-Na 12 (range 6-26). Intention to treat analysis: According to PHES, 30(78.9%) patients showed remission of MHE (p<0.0001). The incidence rate ratio for persisting with MHE was 8 per 38 person-times; that is, 0.2 (95%CI: 0.1-0.5; p<0.0001), with the fraction prevented after exposure to LOLA being 0.78 (95%CI: 0.55-0.90; p<0.0001). According to CFF, 29(76.3%) patients showed remission of MHE (p<0.0001). The incidence rate ratio for persisting with MHE was 9 per 38 person-times; that is, 0.2 (95%CI: 0.1-0.5; p<0.0001), with the fraction prevented after exposure to LOLA being 0.76 (95%CI: 0.51-0-89; p<0.0001). No adverse effects were reported. Per protocol analysis: 34 patients (4 eliminated without evaluation post-LOLA), PHES score improved (baseline -6.44±1.7 vs. post-LOLA -2.79±1.9; p<0.0001), CFF improved (baseline 37±1.8 vs. post-LOLA 39.8±2.2; p<0.0001). According to PHES, 30(88.2%) patients showed remission of MHE (p<0.0001). The incidence rate ratio for persisting with MHE was 4 per 34 person-time; that is, 0.1 (95%CI: 0.04-0.3; p<0.0001), with the fraction prevented after exposure to LOLA being 0.88 (95%CI: 0.67-0.96; p<0.0001). According to CFF, 29(85.3%) patients showed remission of MHE (p<0.0001). The incidence rate ratio for persisting with MHE was 5 per 34 person-times; that is, 0.1 (95%CI: 0.06-0.4; p<0.0001), with the fraction prevented after exposure to LOLA being 0.85 (95%CI: 0.62-0.94; p<0.0001).

Conclusions

LOLA is effective in improving cognitive performance and is evaluated very early by PHES and CFF in cirrhotic patients with MHE.