Effectiveness and safety of lactulose retention enema in cirrhotic patients with grade 3 or grade 4 hepatic encephalopathy

Kaushal Madan; Praveen Sharma; Neeraj Saraf; Sanjay Choudhari; Dyotona Sen Roy

doi:10.18203/2319-2003.ijbcp20170331

Authors

Kaushal Madan Department of Digestive and Liver Diseases, Artemis Hospital, Haryana, India
Praveen Sharma Department of Gastroenterology, Sir Ganga Ram Hospital, New Delhi, India
Neeraj Saraf Department of Gastroenterology, Medanta-The Medicity, Haryana, India
Sanjay Choudhari Department of Medical Affairs, Abbott India Limited, Goregoan, Mumbai, Maharashtra, India
Dyotona Sen Roy Department of Medical Affairs, Abbott India Limited, Goregoan, Mumbai, Maharashtra, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20170331

Keywords:

Complete reversal, Grade 3 and Grade 4 Hepatic encephalopathy, Hepatic encephalopathy, Hospitalization, Lactulose retention enema, West haven criteria

Abstract

Background: Hepatic encephalopathy (HE) is a complex, reversible neuropsychiatric syndrome. The present study evaluated the clinical effectiveness and safety of lactulose retention enema for the treatment of Grade 3 or 4 HE (West Haven Criteria, WHC) in Indian patients.

Methods: This retrospective, open-label, uncontrolled cohort study was conducted at three study centers in India. Patients of either gender (18-65 years) admitted to the hospital with liver cirrhosis having Grade 3 or 4 HE were included. The primary endpoint was to evaluate complete reversal of Grade 3 and 4 HE after 24 h and 48h. The secondary endpoints were grade shift at 24 and 48 h before and after administration of lactulose enema, time to complete reversal of Grade 3 or 4 HE, and mortality. Safety was also evaluated.

Results: Overall, retrospective records of 50 patients were evaluated. Complete reversal of Grade 3 or 4 HE was observed in a statistically significant (p<0.0001) proportion (95% confidence interval) of patients at 24 h (n=40, 80% [66. 3%-90.0%]) and 48 h (n=45, 90% [78. 2%-96.7%]) after treatment. After 24 h of treatment, majority of the patients were noted with Grade 2 (78%) HE. Further improvement was noted after 48 h of treatment with majority of the patients having Grade 2 (40%) and Grade 1 (48%) HE. Mean (SD) time for complete reversal of Grade 3 or 4 HE was 25.39±8.85 h after treatment. All death cases observed (n=6, 12.0%) were assessed as unrelated to the treatment by the investigator, but rather related to the underlying disease and/or precipitating factors. Four non-serious adverse drug reactions in two patients and one rectal device-associated complication in one patient were noted during the patient record reviews.

Conclusions: Lactulose retention enema was clinically effective and resulted in complete reversal of Grade 3 or 4 HE in the majority of patients. It was overall well-tolerated.

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