Designing clinical trials to address alcohol ...
Type de document :
Article dans une revue scientifique: Article de synthèse/Review paper
PMID :
URL permanente :
Titre :
Designing clinical trials to address alcohol use and alcohol-associated liver disease: an expert panel Consensus Statement.
Auteur(s) :
Lee, Brian P. [Auteur]
Witkiewitz, Katie [Auteur]
Mellinger, Jessica [Auteur]
Anania, Frank A. [Auteur]
Bataller, Ramon [Auteur]
Cotter, Thomas G. [Auteur]
Curtis, Brenda [Auteur]
Dasarathy, Srinivasan [Auteur]
Demartini, Kelly S. [Auteur]
Diamond, Ivan [Auteur]
Diazgranados, Nancy [Auteur]
Dimartini, Andrea F. [Auteur]
Falk, Daniel E. [Auteur]
Fernandez, Anne C. [Auteur]
German, Margarita N. [Auteur]
Kamath, Patrick S. [Auteur]
Kidwell, Kelley M. [Auteur]
Leggio, Lorenzo [Auteur]
Litten, Raye [Auteur]
Louvet, Alexandre [Auteur]
Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Lucey, Michael R. [Auteur]
Mccaul, Mary E. [Auteur]
Sanyal, Arun J. [Auteur]
Singal, Ashwani K. [Auteur]
Sussman, Norman L. [Auteur]
Terrault, Norah A. [Auteur]
Thursz, Mark R. [Auteur]
Verna, Elizabeth C. [Auteur]
Radaeva, Svetlana [Auteur]
Nagy, Laura E. [Auteur]
Mitchell, Mack C. [Auteur]
Witkiewitz, Katie [Auteur]
Mellinger, Jessica [Auteur]
Anania, Frank A. [Auteur]
Bataller, Ramon [Auteur]
Cotter, Thomas G. [Auteur]
Curtis, Brenda [Auteur]
Dasarathy, Srinivasan [Auteur]
Demartini, Kelly S. [Auteur]
Diamond, Ivan [Auteur]
Diazgranados, Nancy [Auteur]
Dimartini, Andrea F. [Auteur]
Falk, Daniel E. [Auteur]
Fernandez, Anne C. [Auteur]
German, Margarita N. [Auteur]
Kamath, Patrick S. [Auteur]
Kidwell, Kelley M. [Auteur]
Leggio, Lorenzo [Auteur]
Litten, Raye [Auteur]
Louvet, Alexandre [Auteur]

Institut de Recherche Translationnelle sur l'Inflammation (INFINITE) - U1286
Lucey, Michael R. [Auteur]
Mccaul, Mary E. [Auteur]
Sanyal, Arun J. [Auteur]
Singal, Ashwani K. [Auteur]
Sussman, Norman L. [Auteur]
Terrault, Norah A. [Auteur]
Thursz, Mark R. [Auteur]
Verna, Elizabeth C. [Auteur]
Radaeva, Svetlana [Auteur]
Nagy, Laura E. [Auteur]
Mitchell, Mack C. [Auteur]
Titre de la revue :
Nature reviews. Gastroenterology & hepatology
Nom court de la revue :
Nat Rev Gastroenterol Hepatol
Numéro :
21
Pagination :
626–645
Date de publication :
2024-09
ISSN :
1759-5053
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
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) ...
Lire la suite >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.Lire moins >
Lire la suite >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.Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
Université de Lille
Inserm
CHU Lille
Inserm
CHU Lille
Date de dépôt :
2024-06-25T21:04:35Z
2024-09-09T08:42:40Z
2024-09-09T08:42:40Z