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Clinical drug investigation

Oral L-ornithine-L-aspartate improves health-related quality of life in cirrhotic patients with hepatic encephalopathy: an open-label, prospective, multicentre observational study.


PMID 21208014

Abstract

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. 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). 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. 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.

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O7125
L-Ornithine L-aspartate salt, powder
C9H19N3O6