Use of sodium oxybate for the treatment of alcohol withdrawal syndrome in patients with acute alcohol-associated hepatitis: A 4-patient case report

Author:

Caputo Fabio12,Casabianca Alberto2,Brazzale Camilla1,Lungaro Lisa3ORCID,Costanzini Anna3,Caio Giacomo13,De Giorgio Roberto13,Testino Gianni4,Piscaglia Fabio56,Caraceni Paolo78

Affiliation:

1. Centre for the Study and Treatment of Alcohol-Related Diseases, Department of Translational Medicine, University of Ferrara, Ferrara, Italy

2. Department of Internal Medicine, SS Annunziata Hospital, University of Ferrara, Cento (Ferrara), Italy

3. Department of Translational Medicine, University of Ferrara, Ferrara, Italy

4. Unit of Addiction and Hepatology, ASL3 c/o Ospedale Policlinico San Martino, Genova, Italy

5. Division of Internal Medicine, Hepatobiliary and Immunoallergic Diseases, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy

6. Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy

7. Department of Internal Medicine and Surgery (DIMEC), Alma Mater Studiorum, University of Bologna, Bologna, Italy

8. Unit of Semeiotics, Liver and Alcohol-Related Diseases, IRCCS Azienda Ospedaliero-Universitaria of Bologna, Bologna, Italy.

Abstract

Introduction: During the treatment of alcohol use disorder, alcohol withdrawal syndrome (AWS) can occur. Benzodiazepines remain the “gold standard” for the pharmacological treatment of AWS. However, other drugs have been approved in some European Countries for the treatment of AWS: namely, clomethiazole in Spain and Germany and sodium oxybate in Italy and Austria. Acute alcohol-associated hepatitis (AAH) is a distinct clinical syndrome characterized by the recent onset of jaundice with or without other signs of liver decompensation in patients with ongoing alcohol consumption. Rationale: We report 4 paradigmatic clinical cases to analyze the efficacy, safety, and tolerability of the very short half-life (30–45 minutes) sodium oxybate (SO) in the management of AWS with moderate to severe AAH. Compared to SO, “as needed” short-acting benzodiazepines, currently prescribed to treat AWS in patients with AAH, have a much longer half-life (5–25 hours) which increases the risk of drug accumulation. The very short half-life of SO provides a fixed dose approach allowing for a more effective control of AWS than “as needed” therapy throughout the 24 hours. Patient concerns: Patients reported anxiety, agitation, diffuse abdominal pain, loss of appetite, and nausea with elevation in serum bilirubin and 2 of them had abdomen distension due to ascites. Diagnosis: Patients were affected by moderate or severe AWS and moderate or severe AAH on alcohol-related liver cirrhosis. Interventions: In order to suppress AWS, all patients were treated with oral sodium oxybate at a dose of 25 mg/kg/day, progressively increased to 50 to 100 mg/kg/day, divided into 3 to 5 administrations. Outcomes: SO was efficient, safe and tolerable in suppressing AWS even in patients with severe AAH. All treated patients showed a rapid improvement of all symptom (via the Clinical Institute of Withdrawal Assessment for Alcohol Scale) and liver test scores (Model for End-Stage Liver Disease). Conclusion: Because of its short half-life, SO can be considered a safe and effective pharmacological option for the AWS in patients with moderate to severe AAH even in comparison to short-acting benzodiazepines, thus avoiding the risk of accumulation. Notably, SO guarantees a fixed approach to cover the possible onset of AWS throughout the 24 hours.

Publisher

Ovid Technologies (Wolters Kluwer Health)

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