Designing clinical trials to address alcohol use and alcohol-associated liver disease: an expert panel Consensus Statement.


Journal

Nature reviews. Gastroenterology & hepatology
ISSN: 1759-5053
Titre abrégé: Nat Rev Gastroenterol Hepatol
Pays: England
ID NLM: 101500079

Informations de publication

Date de publication:
07 Jun 2024
Historique:
accepted: 22 04 2024
medline: 8 6 2024
pubmed: 8 6 2024
entrez: 7 6 2024
Statut: aheadofprint

Résumé

Most patients with alcohol-associated liver disease (ALD) engage in heavy drinking defined as 4 or more drinks per day (56 g) or 8 (112 g) or more drinks per week for women and 5 or more drinks per day (70 g) or 15 (210 g) or more drinks per week for men. Although abstinence from alcohol after diagnosis of ALD improves life expectancy and reduces the risk of decompensation of liver disease, few studies have evaluated whether treatment of alcohol use disorders will reduce progression of liver disease and improve liver-related outcomes. In November 2021, the National Institute of Alcohol Abuse and Alcoholism commissioned a task force that included hepatologists, addiction medicine specialists, statisticians, clinical trialists and members of regulatory agencies to develop recommendations for the design and conduct of clinical trials to evaluate the effect of alcohol use, particularly treatment to reduce or eliminate alcohol use in patients with ALD. The task force conducted extensive reviews of relevant literature on alcohol use disorders and ALD. Findings were presented at one in-person meeting and discussed over the next 16 months to develop the final recommendations. As few clinical trials directly address this topic, the 28 recommendations approved by all members of the task force represent a consensus of expert opinions.

Identifiants

pubmed: 38849555
doi: 10.1038/s41575-024-00936-x
pii: 10.1038/s41575-024-00936-x
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024. Springer Nature Limited.

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Auteurs

Brian P Lee (BP)

Division of Gastroenterology and Liver Diseases, University of Southern California Keck School of Medicine and Institute for Addiction Science, University of Southern California, Los Angeles, CA, USA.

Katie Witkiewitz (K)

Center on Alcohol, Substance use and Addictions, University of New Mexico, Albuquerque, NM, USA.

Jessica Mellinger (J)

Department of Internal Medicine, Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA.

Frank A Anania (FA)

Division of Hepatology and Nutrition, US Food and Drug Administration, Silver Spring, MD, USA.

Ramon Bataller (R)

Liver Unit, Hospital Clinic, Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain.

Thomas G Cotter (TG)

Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, TX, USA.

Brenda Curtis (B)

Technology and Translational Research Unit, Translational Addiction Medicine Branch, National Institute on Drug Abuse Intramural Research Program, Baltimore, MD, USA.

Srinivasan Dasarathy (S)

Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH, USA.

Kelly S DeMartini (KS)

Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.

Ivan Diamond (I)

Amygdala Neurosciences, Palo Alto, CA, USA.

Nancy Diazgranados (N)

Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.

Andrea F DiMartini (AF)

Departments of Psychiatry and Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.

Daniel E Falk (DE)

Medications Development Branch, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.

Anne C Fernandez (AC)

Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA.

Margarita N German (MN)

Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.

Patrick S Kamath (PS)

Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.

Kelley M Kidwell (KM)

Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, MI, USA.

Lorenzo Leggio (L)

Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, Translational Addiction Medicine Branch, National Institute on Drug Abuse Intramural Research Program and National Institute on Alcohol Abuse and Alcoholism Division of Intramural Clinical and Biological Research, National Institutes of Health, Baltimore, MD, USA.

Raye Litten (R)

Division of Treatment and Recovery, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.

Alexandre Louvet (A)

Service des maladies de l'appareil digestif, University Hospital of Lille, Lille, France.
Unité INSERM INFINITE, Lille, France.

Michael R Lucey (MR)

Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.

Mary E McCaul (ME)

Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.

Arun J Sanyal (AJ)

Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University School of Medicine, Richmond, VA, USA.

Ashwani K Singal (AK)

Department of Medicine, Division of Gastroenterology Hepatology and Nutrition, University of Louisville School of Medicine, Louisville, KY, USA.
Department of Medicine, Robley Rex VA Medical Center, Louisville, KY, USA.

Norman L Sussman (NL)

DURECT Corporation, Cupertino, CA, USA.
Baylor College of Medicine, Houston, TX, USA.

Norah A Terrault (NA)

Division of Gastroenterology and Liver Diseases, University of Southern California Keck School of Medicine and Institute for Addiction Science, University of Southern California, Los Angeles, CA, USA.

Mark R Thursz (MR)

Division of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK.

Elizabeth C Verna (EC)

Division of Digestive and Liver Diseases, Columbia University, New York, NY, USA.

Svetlana Radaeva (S)

Svetlana Radaeva, Division of Metabolism and Health Effects, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA.

Laura E Nagy (LE)

Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA. nagyL3@ccf.org.

Mack C Mitchell (MC)

Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA. mack.mitchell@utsouthwestern.edu.

Classifications MeSH