title: Oral L-ornithine-L-aspartate improves health-related quality of life in cirrhotic patients with hepatic encephalopathy: an open-label, prospective, multicentre observational study.
abstract: OBJECTIVE
  Hepatic encephalopathy (HE) is a serious complication of cirrhosis. Clinical trials have consistently shown that L-ornithine-L-aspartate significantly improves HE symptoms. Health-related quality of life (HR-QOL) is impaired in HE patients and represents an important outcome measure for therapeutic intervention. The present study aimed to assess the impact of L-ornithine-L-aspartate on HR-QOL and safety in patients with HE in a clinical practice setting.
  
  
  METHODS
  This was an open-label, prospective, multicentre observational study in clinical practice (general practitioners in Germany) that included 191 cirrhotic patients with HE. Patients were administered three sachets daily of L-ornithine-L-aspartate 6 g (Hepa-Merz®, Merz Pharmaceuticals GmbH, Frankfurt/Main, Germany) dissolved in water taken during or after meals. L-ornithine-L-aspartate was administered over a period of 8 weeks. The main outcome variable was the mean change in HR-QOL over the observation period as assessed by the patients using the German-validated version of the Chronic Liver Disease Questionnaire (CLDQ-D). Further assessments included mean changes in the severity of cirrhosis/HE-related symptoms, changes in disease severity (measured on the modified Clinical Global Impression-Severity [CGI-S] scale), and changes in disease status (measured on the modified CGI-Improvement [CGI-I] scale).
  
  
  RESULTS
  Treatment with L-ornithine-L-aspartate for 8 weeks markedly improved all HR-QOL domains, in particular fatigue (67.5% improvement), resulting in a mean±SD CLDQ-D sum score improvement from 3.53±1.03 at baseline to 5.04±0.93 at the end of treatment. Symptom severity also improved, with particular benefits seen in fatigue, sleep quality and concentration deficits. Patient self-assessment correlated well with the physicians' clinical evaluation. Physicians rated 70.0% of the patients very much or much improved at the end of treatment. Very good or good tolerability was observed in 97.8% of patients. No drug-related adverse events were reported.
  
  
  CONCLUSIONS
  Treatment of HE with oral L-ornithine-L-aspartate in cirrhotic patients markedly improved HR-QOL and was well tolerated by 97.8% of patients.
authors.affiliation: University of Philippines, Manila, Philippines.
authors.forename: Janus P
authors.initials: JP
authors.lastname: Ong
authors.forename: Gerd
authors.initials: G
authors.lastname: Oehler
authors.forename: Christiane
authors.initials: C
authors.lastname: Krüger-Jansen
authors.forename: Judith
authors.initials: J
authors.lastname: Lambert-Baumann
authors.forename: Zobair M
authors.initials: ZM
authors.lastname: Younossi
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D004151:Dipeptides / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006501:Hepatic Encephalopathy / Q000188:drug therapy* / Q000209:etiology / Q000523:psychology; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life
chemical_list: D004151:Dipeptides; C002939:ornithylaspartate