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

Autor: 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., Witkiewitz K; Center on Alcohol, Substance use and Addictions, University of New Mexico, Albuquerque, NM, USA., Mellinger J; Department of Internal Medicine, Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA., Anania FA; Division of Hepatology and Nutrition, US Food and Drug Administration, Silver Spring, MD, USA., Bataller R; Liver Unit, Hospital Clinic, Institut d'Investigacions Biomediques August Pi i Sunyer (IDIBAPS), Barcelona, Spain., Cotter TG; Division of Digestive and Liver Diseases, University of Texas Southwestern Medical Center, Dallas, TX, USA., Curtis B; Technology and Translational Research Unit, Translational Addiction Medicine Branch, National Institute on Drug Abuse Intramural Research Program, Baltimore, MD, USA., Dasarathy S; Department of Gastroenterology and Hepatology, Cleveland Clinic, Cleveland, OH, USA., DeMartini KS; Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA., Diamond I; Amygdala Neurosciences, Palo Alto, CA, USA., Diazgranados N; Office of the Clinical Director, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA., DiMartini AF; Departments of Psychiatry and Surgery, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA., Falk DE; Medications Development Branch, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA., Fernandez AC; Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA., German MN; Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA., Kamath PS; Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine and Science, Rochester, MN, USA., Kidwell KM; Department of Biostatistics, University of Michigan School of Public Health, Ann Arbor, MI, USA., 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., Litten R; Division of Treatment and Recovery, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA., Louvet A; Service des maladies de l'appareil digestif, University Hospital of Lille, Lille, France.; Unité INSERM INFINITE, Lille, France., Lucey MR; Division of Gastroenterology and Hepatology, Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA., McCaul ME; Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA., Sanyal AJ; Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, Virginia Commonwealth University School of Medicine, Richmond, VA, USA., 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., Sussman NL; DURECT Corporation, Cupertino, CA, USA.; Baylor College of Medicine, Houston, TX, USA., 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., Thursz MR; Division of Digestive Diseases, Department of Metabolism, Digestion and Reproduction, Imperial College London, London, UK., Verna EC; Division of Digestive and Liver Diseases, Columbia University, New York, NY, USA., Radaeva S; Svetlana Radaeva, Division of Metabolism and Health Effects, National Institute on Alcohol Abuse and Alcoholism, Bethesda, MD, USA., Nagy LE; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic, Cleveland, OH, USA. nagyL3@ccf.org., Mitchell MC; Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX, USA. mack.mitchell@utsouthwestern.edu.
Jazyk: angličtina
Zdroj: Nature reviews. Gastroenterology & hepatology [Nat Rev Gastroenterol Hepatol] 2024 Sep; Vol. 21 (9), pp. 626-645. Date of Electronic Publication: 2024 Jun 07.
DOI: 10.1038/s41575-024-00936-x
Abstrakt: 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.
(© 2024. Springer Nature Limited.)
Databáze: MEDLINE
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