Journal Article

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

Litten, Raye, Mitchell, Mack C., DiMartini, Andrea F., Leggio, Lorenzo, Mellinger, Jessica, German, Margarita N., Verna, Elizabeth C., Diamond, Ivan, Cotter, Thomas G., Curtis, Brenda, Witkiewitz, Katie, Sussman, Norman L., Lee, Brian P., Kamath, Patrick S., Falk, Daniel E., Thursz, Mark R., Lucey, Michael R., Sanyal, Arun J., Terrault, Norah A., Dasarathy, Srinivasan, McCaul, Mary E., Louvet, Alexandre, Kidwell, Kelley M., Fernandez, Anne C., DeMartini, Kelly S., Diazgranados, Nancy, Singal, Ashwani K., Bataller, Ramon, Anania, Frank A., Radaeva, Svetlana, Nagy, Laura E.

2024

Overview

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. Alcohol-associated liver disease is the main cause of liver-related morbidity and mortality globally. This Consensus Statement makes recommendations for the design, best practice and conduct of clinical trials to evaluate the effects of alcohol use in alcohol-associated liver disease and alcohol use disorder.

• Publisher: Nature Publishing Group UK,Nature Publishing Group,Nature Publishing Group, 2009
• Subject: 692/4020/4021 / 692/4020/4021/1607/1608 / Alcohol Drinking - adverse effects / Alcohol use / Alcoholism - complications / Alcoholism - therapy / Beverages / Biomedicine / Clinical trials / Clinical Trials as Topic / Consensus / Consensus Statement / Drinking behavior / Drug abuse / Drug addiction / Gastroenterology / Hepatology / Humans / Life Sciences / Life span / Liver diseases / Liver Diseases, Alcoholic - therapy / Medical treatment / Medicine / Medicine & Public Health / Morbidity / Patients / Research Design / Task forces