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

Author

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

Published
2024
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3. Randomized trial of anakinra plus zinc vs. prednisone for severe alcohol-associated hepatitis

Author

Chalasani, Naga, Patidar, Kavish R., Vuppalanchi, Raj, Samala, Niha, Yoder, Lindsey, Nephew, Lauren, Shah, Vijay H., Simonetto, Douglas A., Kamath, Patrick, Vargas, Hugo E., Yang, Liu, Dasarathy, Srinivasan, Welch, Nicole, Bellar, Annette, Attaway, Amy, Dasarathy, Jaividhya, Growley, Ashley, Streem, David, Nagy, Laura E., Mitchell, Mack C., Herlong, H. Franklin, Kerr, Thomas, Cotter, Thomas, Sanyal, Arun, O'Connor, Sara, Luketic, Velimir, Asgharpour, Amon, Taylor, Stephanie, McClain, Craig J., Vatsalya, Vatsalya, Jophlin, Loretta, Cave, Matt, Jha, Suman Kumar, Marsano, Luis, Barve, Ashutosh, Frimodig, Jane, Bataller, Ramon, Ravi, Samhita, Behari, Jaideep, Shivanekar, Sharvari, Novelli, Paula, Duarte-Rojo, Andres, Jonassaint, Naudia, Szabo, Gyongyi, Curry, Jiang, Zhenghui G., Agarwal, Ushma, Hazel, Mia, Schnabl, Bernd, Gawrieh, Samer, Tu, Wanzhu, Kamath, Patrick S., Chalasani, Naga P., Tang, Qing, Radaeva, Svetlana, Barton, Bruce, and Sanyal, Arun J.

Published
2024
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5. Racial and Ethnic Disparities in Liver Transplantation for Alcohol-associated Liver Diseases in the United States

Author

Cotter, Thomas G., Mitchell, Mack C., Patel, Mausam J., Anouti, Ahmad, Lieber, Sarah R., Rich, Nicole E., Arab, Juan Pablo, Díaz, Luis Antonio, Louissaint, Jeremy, Kerr, Thomas, Mufti, Arjmand R., Hanish, Steven I., Vagefi, Parsia A., Patel, Madhukar S., VanWagner, Lisa B., Lee, William M., O’Leary, Jacqueline G., and Singal, Amit G.

Published
2024
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7. Racial and Ethnic Disparities in Liver Transplantation for Alcohol-associated Liver Diseases in the United States

Author

Cotter, Thomas G., Mitchell, Mack C., Patel, Mausam J., Anouti, Ahmad, Lieber, Sarah R., Rich, Nicole E., Arab, Juan Pablo, Díaz, Luis Antonio, Louissaint, Jeremy, Kerr, Thomas, Mufti, Arjmand R., Hanish, Steven I., Vagefi, Parsia A., Patel, Madhukar S., VanWagner, Lisa B., Lee, William M., O’Leary, Jacqueline G., and Singal, Amit G.

Published
2023
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10. Racial and ethnic disparities in alcohol-associated liver disease in the United States: A systematic review and meta-analysis

Author

Anouti, Ahmad, primary, Seif El Dahan, Karim, additional, Rich, Nicole E., additional, Louissaint, Jeremy, additional, Lee, William M., additional, Lieber, Sarah R., additional, Arab, Juan Pablo, additional, Zhang, Bill Y., additional, Patel, Mausam J., additional, Thimphittaya, Chanattha, additional, Díaz, Luis Antonio, additional, Gregory, Dyanna L., additional, Kozlitina, Julia, additional, VanWagner, Lisa B., additional, King, Andrea C., additional, Mitchell, Mack C., additional, Singal, Amit G., additional, and Cotter, Thomas G., additional

Published
2024
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11. Randomized-controlled trial of anakinra plus zinc vs. prednisone for severe alcohol-associated hepatitis

Author

Gawrieh, Samer, primary, Dasarathy, Srinivasan, additional, Tu, Wanzhu, additional, Kamath, Patrick S., additional, Chalasani, Naga P., additional, McClain, Craig J., additional, Bataller, Ramon, additional, Szabo, Gyongyi, additional, Tang, Qing, additional, Radaeva, Svetlana, additional, Barton, Bruce, additional, Nagy, Laura E., additional, Shah, Vijay H., additional, Sanyal, Arun J., additional, and Mitchell, Mack C., additional

Published
2024
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12. Standard Definitions and Common Data Elements for Clinical Trials in Patients With Alcoholic Hepatitis: Recommendation From the NIAAA Alcoholic Hepatitis Consortia

Author

Crabb, David W, Bataller, Ramon, Chalasani, Naga P, Kamath, Patrick S, Lucey, Michael, Mathurin, Philippe, McClain, Craig, McCullough, Arthur, Mitchell, Mack C, Morgan, Timothy R, Nagy, Laura, Radaeva, Svetlana, Sanyal, Arun, Shah, Vijay, and Szabo, Gyongyi

Subjects
Clinical Trials as Topic/classification/*standards, Consensus, Endpoint Determination, Hepatitis, Alcoholic/classification/*diagnosis/mortality/therapy, Humans, Research Design/*standards, Risk Factors, Severity of Illness Index, Terminology as Topic, Time Factors, Treatment Outcome
Abstract

Heavy drinkers are at risk for a spectrum of histologic alcohol-related liver injury: steatosis, alcoholic steatohepatitis (ASH), alcohol-related fibrosis, and cirrhosis. Alcoholic hepatitis (AH), the clinical entity associated with severe ASH, has high short-term mortality. The standard-of-care therapy, prednisolone, has limited efficacy and many side effects; no other treatment has consistently shown survival benefit. The National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded Alcoholic Hepatitis Consortia carry out translational research on pathophysiologic mechanisms, genetic and environmental risk factors, phase II clinical trials, and development of biomarkers. The consortia members were convened by the National Institutes of Health to address diagnostic criteria and practical issues related to clinical AH research, and to develop a set of common data elements to harmonize ongoing and future trials. This was accomplished through 3 face-to-face meetings of the investigators and representatives of the National Institutes of Health, and subsequent electronic communications over the course of 6 months. Evidence for the recommendations was based on published trials and observational data from several of the consortia members. A draft manuscript was iteratively reviewed by members of the consortia. The goal was to reach agreements on recommendations and definitions that could facilitate trial design, and simultaneously be tested by research groups pooling their data. The recommendations made here are specifically directed to achieve better uniformity in clinical trials, rather than serving as clinical practice guidelines.

Published
2016

17. Contributors

Author

Allampati, Sanath, primary, Ayles, Helen M., additional, Bacon, Bruce R., additional, Bailey, Sarah Lou, additional, Balistreri, William F., additional, Bang, Ji Young, additional, Benias, Petros C., additional, Berenguer, Marina, additional, Bethea, Emily D., additional, Bhamidimarri, Kalyan Ram, additional, Bowlus, Christopher L., additional, Cardenas, Andres, additional, Carrion, Andres F., additional, Choi, Steve S., additional, Chopra, Sanjiv, additional, Chung, Raymond T., additional, Cobbold, Jeremy F.L., additional, Curry, Michael P., additional, Czaja, Albert J., additional, de Castro, Teresita Gomez, additional, deLemos, Andrew S., additional, Di Bisceglie, Adrian M., additional, Diehl, Anna Mae, additional, Fontana, Robert J., additional, Friedman, Lawrence S., additional, Ginès, Pere, additional, Grace, Norman D., additional, Han, Steven-Huy B., additional, Hirschfield, Gideon M., additional, House, Michael G., additional, Waasdorp Hurtado, Christine E., additional, Jacobson, Ira M., additional, Kowdley, Kris V., additional, Lai, Michelle, additional, Lefkowitch, Jay H., additional, Lertudomphonwanit, Chatmanee, additional, Lewis, James H., additional, Lillemoe, Keith D., additional, Lo Re, Vincent, additional, Manickavasagan, Hanisha, additional, Martin, Paul, additional, Mayo, Marlyn J., additional, Mitchell, Mack C., additional, Mullen, Kevin D., additional, Muñoz, Santiago J., additional, Neuschwander-Tetri, Brent A., additional, Nguyen, Kelvin T., additional, Patidar, Kavish R., additional, Pringle, Patricia, additional, Procaccini, Nicholas J., additional, Puleo, James, additional, Reddy, K. Rajender, additional, Rosen, Hugo R., additional, Sanyal, Arun J., additional, Schilsky, Michael L., additional, Sherman, Stuart, additional, Sokol, Ronald J., additional, Spengler, Erin, additional, Stoffel, Elena M., additional, Summerfield, John A., additional, Tapper, Elliot B., additional, Tran, Tram T., additional, Vinaixa, Carmen, additional, Webb, Gwilym J., additional, Weine, Douglas M., additional, Wolf, Jacqueline L., additional, Wong, Florence S., additional, and Zhang, Wei, additional

Published
2018
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19. Reply

Author

Szabo, Gyongyi, primary, Mitchell, Mack C., additional, Dasarathy, Srinivasan, additional, and McClain, Craig, additional

Published
2023
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22. Alcohol-induced extracellular ASC specks perpetuate liver inflammation and damage in alcohol-associated hepatitis even after alcohol cessation.

Author

de Carvalho Ribeiro, Marcelle, Iracheta-Vellve, Arvin, Babuta, Mrigya, Calenda, Charles D., Copeland, Christopher, Zhuang, Yuan, Lowe, Patrick P., Hawryluk, Danielle, Catalano, Donna, Cho, Yeonhee, Barton, Bruce, Dasarathy, Srinivasan, McClain, Craig, McCullough, Arthur J., Mitchell, Mack C., Nagy, Laura E., Radaeva, Svetlana, Lien, Egil, Golenbock, Douglas T., and Szabo, Gyongyi

Published
2023
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26. “Raising HOPE”: Improved Outcomes for HIV/HCV-coinfected Liver Transplant Recipients in the Direct-acting Antiviral Era

Author

Cotter, Thomas G., primary, Wang, Jennifer, additional, Lieber, Sarah R., additional, Odenwald, Matthew A., additional, Rich, Nicole E., additional, Marrero, Jorge A., additional, Singal, Amit G., additional, Mitchell, Mack C., additional, Aronsohn, Andrew, additional, Charlton, Michael, additional, and Fung, John, additional

Published
2021
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29. Contributors

Author

Alexander, Jacob, primary, Avanesyan, Armine, additional, Ayles, Helen M., additional, Babich, Jay P., additional, Bailey, Sarah Lou, additional, Balistreri, William F., additional, Benlloch, Salvador, additional, Berenguer, Marina, additional, Black, Martin, additional, Bowlus, Christopher L., additional, Cheney, Catherine Petruff, additional, Chopra, Sanjiv, additional, Chung, Raymond T., additional, Cobbold, Jeremy F.L., additional, Czaja, Albert J., additional, Di Bisceglie, Adrian M., additional, Diehl, Anna Mae, additional, Friedman, Lawrence S., additional, Goessling, Wolfram, additional, Goldberg, Eric Mathew, additional, Gollan, John L., additional, Gonzalez, Stevan A., additional, Grace, Norman D., additional, Guevara, Mónica, additional, Heathcote, E. Jenny, additional, Hewlett, Alexander T., additional, Hirschfield, Gideon M., additional, House, Michael G., additional, Hu, Ke-Qin, additional, Waasdorp Hurtado, Christine E., additional, Jacobson, Ira M., additional, Jou, Janice H., additional, Keeffe, Emmet B., additional, Koff, Raymond S., additional, Kowdley, Kris V., additional, Lai, Michelle, additional, Lefkowitch, Jay H., additional, Lillemoe, Keith D., additional, Lo Re, Vincent, additional, Malet, Peter F., additional, Martin, Paul, additional, Mitchell, Mack C., additional, Mullen, Kevin D., additional, Muñoz, Santiago J., additional, Neuschwander-Tetri, Brent A., additional, O’Leary, Jacqueline G., additional, Patel, Vishal, additional, Prakash, Ravi K., additional, Puleo, James, additional, Rabie, Rania, additional, Reddy, K. Rajender, additional, Rodés, Juan, additional, Rosen, Hugo R., additional, Runyon, Bruce A., additional, Schiano, Thomas D., additional, Sokol, Ronald J., additional, Stoffel, Elena M., additional, Summerfield, John A., additional, Vitola, Bernadette, additional, Weine, Douglas M., additional, Wolf, Jacqueline L., additional, and Wong, Florence S., additional

Published
2012
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37. Medical Management of Severe Alcoholic Hepatitis

Author

Mitchell, Mack C. and McClain, Craig J.

Subjects
Liver, Hepatitis, Alcoholic, Practice Guidelines as Topic, Humans, Article
Abstract

The purpose of this clinical practice update is to review diagnostic criteria for severe acute alcoholic hepatitis and to determine the current best practices for this life-threatening condition. The best practices in this review are based on clinical trials, systematic reviews including meta-analysis and expert opinion to develop an approach to diagnosis and management. Best Practice Advice 1: Abstinence from drinking alcohol is the cornerstone of treatment for alcohol hepatitis (AH). Best Practice Advice 2: Patients with jaundice and suspected AH should have cultures of blood, urine, and ascites, if present, to determine the presence of bacterial infections regardless of whether they have fever. Best Practice Advice 3: Patients with AH who have jaundice should be admitted to the hospital to encourage abstinence, restore adequate nutrition, and exclude serious infections. Best Practice Advice 4: Imaging of the liver is warranted as part of the evaluation, but caution should be used in administering iodinated contrast dye, as it increases the risk of acute kidney injury (AKI). Best Practice Advice 5: Patients with AH require a diet with 1-1.5 g protein and 30-40 kcal/kg body weight for adequate recovery. If the patient is unable to eat because of anorexia or altered mental status, a feeding tube should be considered for enteral feeding. Parenteral nutrition alone is inadequate. Best Practice Advice 6: Severity and prognosis of AH should be evaluated using Maddrey Discriminant Function (MDF), Model for End-Stage Liver Disease (MELD), age, bilirubin, international normalized ratio, and creatinine (ABIC), or Glasgow scoring systems. Current treatments are based on this assessment. Best Practice Advice 7: Presence of systemic inflammatory response syndrome (SIRS) on admission is associated with an increased risk of multi-organ failure (MOF) syndrome. Development of MOF, usually due to infections developing after initial diagnosis of AH, is associated with a very high mortality rate. Best Practice Advice 8: Nephrotoxic drugs, including diuretics, should be avoided or used sparingly in patients with AH, since AKI is an early manifestation of MOF. Best Practice Advice 9: Patients with MDF32 or MELD score20 without a contraindication to glucocorticoid, such as hepatitis B viral infection, tuberculosis, or other serious infectious diseases, may be treated with methylprednisolone 32 mg daily, but the appropriate duration of treatment remains a subject of controversy. Methylprednisolone does not improve survival beyond 28 days, and the benefits for28 days are modest. Best Practice Advice 10: Patients with a contraindication to glucocorticoids may be treated with pentoxifylline 400 mg three times daily with meals. Data regarding the efficacy are conflicting. Best Practice Advice 11: Patients with severe AH, particularly those with a MELD score26 with good insight into their alcohol use disorder and good social support should be referred for evaluation for liver transplantation, as the 90-day mortality rate is very high. Best Practice Advice 12: Patients with mild to moderate AH defined by a MELD score20 and MDF32 should be referred for abstinence counseling and prescribed a high protein diet supplemented with B vitamins and folic acid.

Published
2017

38. Current Management and Future Treatment of Alcoholic Hepatitis.

Author

Mitchell, Mack C., Kerr, Thomas, and Herlong, H. Franklin

Subjects
HEPATITIS treatment, COMPLICATIONS of alcoholism, HEPATITIS
Abstract

Excessive alcohol consumption is responsible for approximately 50% of all deaths due to cirrhosis. Although the duration and amount of alcohol consumption are the primary factors responsible for the liver injury caused by consuming alcohol, the pathogenesis of the 3 stages of alcohol-associated liver disease (ALD)--fatty liver, alcoholic hepatitis (AH), and cirrhosis-- is likely multifactorial. Preexisting obesity, dysbiosis of the gut microbiome, activation of proinflammatory cytokines, and genetic factors can all contribute to the risk of developing ALD. The cornerstone of therapy for all stages of ALD is abstinence from drinking alcoholic beverages. Severe AH, defined by a Maddrey discriminant function greater than 32, warrants additional therapy. The results of multiple studies evaluating the use of glucocorticoids in the treatment of severe AH led to guidelines from international societies that recommend glucocorticoid therapy in patients with severe AH without active infection. Liver transplantation provides an effective treatment option for patients who fail glucocorticoid therapy. Recent advances in understanding the pathogenesis of AH have led to the investigation of potential therapies directed at preventing the development of steatosis, inhibiting the innate immune response, modifying the gut microbiome, and stimulating liver regeneration. [ABSTRACT FROM AUTHOR]

Published
2020

44. New Frontiers in Alcohol and Health : - The birth of ERAB- Introduction- Heavy alcohol intake episodes: determinants and interventions- Alcohol and the risk of cancer- Alcoholic liver disease- Alcohol and its effects on the cardiovascular system- Brain, behaviour, genetic findings and pharmacological treatment in alcohol dependence- Conclusion

Author

UCL - SST/ELI/ELIM - Applied Microbiology, Catholic University of Rome - Italy - Department of Internal Medicine, University of Newcastle - UK - Institute of Cellular Medicine, University of Newcastle - UK - Faculty of Medical Sciences, University of Ulm - Germany - Department of Internal Medicine II - Cardiology, Johns Hopkins Bayview Medical Center - Department of Gastroenterology, Finnish Foundation for Alcohol Studies - Finland - Finnish Foundation for Alcohol Studies, Maastricht University - The Netherlands - Department of Epidemiology, De Witte, Philippe, Addolorato, Giovanni, Day, Chris P., James, Oliver F., Koenig, Wolfgang, Mitchell, Mack C., Poikolainen, Kari, Weijenberg, Matty P., UCL - SST/ELI/ELIM - Applied Microbiology, Catholic University of Rome - Italy - Department of Internal Medicine, University of Newcastle - UK - Institute of Cellular Medicine, University of Newcastle - UK - Faculty of Medical Sciences, University of Ulm - Germany - Department of Internal Medicine II - Cardiology, Johns Hopkins Bayview Medical Center - Department of Gastroenterology, Finnish Foundation for Alcohol Studies - Finland - Finnish Foundation for Alcohol Studies, Maastricht University - The Netherlands - Department of Epidemiology, De Witte, Philippe, Addolorato, Giovanni, Day, Chris P., James, Oliver F., Koenig, Wolfgang, Mitchell, Mack C., Poikolainen, Kari, and Weijenberg, Matty P.

Published
2010

46. Endoscopic Suturing for Transoral Outlet Reduction Increases Weight Loss After Roux-en-Y Gastric Bypass Surgery

Author

Thompson, Christopher C., primary, Chand, Bipan, additional, Chen, Yang K., additional, DeMarco, Daniel C., additional, Miller, Larry, additional, Schweitzer, Michael, additional, Rothstein, Richard I., additional, Lautz, David B., additional, Slattery, James, additional, Ryan, Michele B., additional, Brethauer, Stacy, additional, Schauer, Phillip, additional, Mitchell, Mack C., additional, Starpoli, Anthony, additional, Haber, Gregory B., additional, Catalano, Marc F., additional, Edmundowicz, Steven, additional, Fagnant, Annette M., additional, Kaplan, Lee M., additional, and Roslin, Mitchell S., additional

Published
2013
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49. M1359 Restore: Randomized Evaluation of Endoscopic Suturing Transorally for Anastomotic Outlet Reduction: A Double-Blind, Sham-Controlled Multicenter Study for Treatment of Inadequate Weight Loss or Weight Regain Following Roux-en-Y Gastric Bypass

Author

Thompson, Christopher C., primary, Roslin, Mitchell S., additional, Chand, Bipan, additional, Chen, Yang K., additional, DeMarco, Daniel C., additional, Miller, Larry S., additional, Schweitzer, Michael, additional, Rothstein, Richard I., additional, Lautz, David B., additional, Ryan, Michele B., additional, Brethauer, Stacy A., additional, Schauer, Philip R., additional, Mitchell, Mack C., additional, Starpoli, Anthony A., additional, Haber, Gregory B., additional, Catalano, Marc F., additional, Edmundowicz, Steven A., additional, Fagnant, Annette, additional, and Kaplan, Lee M., additional

Published
2010
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