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1. Treatment With Simvastatin and Rifaximin Restores the Plasma Metabolomic Profile in Patients With Decompensated Cirrhosis

Author

Elisa Pose, Elsa Solà, Juan J. Lozano, Adrià Juanola, Julia Sidorova, Giacomo Zaccherini, Koos deWit, Frank Uschner, Marta Tonon, Konstantin Kazankov, Cesar Jiménez, Daniela Campion, Laura Napoleone, Ann T. Ma, Marta Carol, Manuel Morales‐Ruiz, Carlo Alessandria, Ulrich Beuers, Paolo Caraceni, Claire Francoz, François Durand, Rajeshwar P. Mookerjee, Jonel Trebicka, Victor Vargas, Salvatore Piano, Hugh Watson, Juan G. Abraldes, Patrick S. Kamath, Mark M. Davis, Pere Ginès, and for the investigators of the LIVERHOPE Consortium

Subjects
Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Patients with decompensated cirrhosis, particularly those with acute‐on‐chronic liver failure (ACLF), show profound alterations in plasma metabolomics. The aim of this study was to investigate the effect of treatment with simvastatin and rifaximin on plasma metabolites of patients with decompensated cirrhosis, specifically on compounds characteristic of the ACLF plasma metabolomic profile. Two cohorts of patients were investigated. The first was a descriptive cohort of patients with decompensated cirrhosis (n = 42), with and without ACLF. The second was an intervention cohort from the LIVERHOPE‐SAFETY randomized, double‐blind, placebo‐controlled trial treated with simvastatin 20 mg/day plus rifaximin 1,200 mg/day (n = 12) or matching placebo (n = 13) for 3 months. Plasma samples were analyzed using ultrahigh performance liquid chromatography–tandem mass spectroscopy for plasma metabolomics characterization. ACLF was characterized by intense proteolysis and lipid alterations, specifically in pathways associated with inflammation and mitochondrial dysfunction, such as the tryptophan–kynurenine and carnitine beta‐oxidation pathways. An ACLF‐specific signature was identified. Treatment with simvastatin and rifaximin was associated with changes in 161 of 985 metabolites in comparison to treatment with placebo. A remarkable reduction in levels of metabolites from the tryptophan–kynurenine and carnitine pathways was found. Notably, 18 of the 32 metabolites of the ACLF signature were affected by the treatment. Conclusion: Treatment with simvastatin and rifaximin modulates some of the pathways that appear to be key in ACLF development. This study unveils some of the mechanisms involved in the effects of treatment with simvastatin and rifaximin in decompensated cirrhosis and sets the stage for the use of metabolomics to investigate new targeted therapies in cirrhosis to prevent ACLF development.

Published
2022
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2. Different inflammasome activation predisposes for acute-on-chronic liver failure depending on hepatic compensation in human and experimental liver cirrhosis

Author

Sofia Monteiro, Josephine Grandt, Frank Uschner, Nina Kimer, Jan Lysgaard Madsen, Robert Schierwagen, Sabine Klein, Christoph Welsch, Liliana Schaefer, Joan Clària, Vicente Arroyo, Richard Moreau, Javier Fernandez, Flemming Bendtsen, Gautam Mehta, Lise Lotte Gluud, Søren Møller, Michael Praktiknjo, and Jonel Trebicka

Subjects
Hepatology
Published
2020
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3. Endpoints and design of clinical trials in patients with decompensated cirrhosis: Position paper of the LiverHope Consortium

Author

E. Palacio, Koos de Wit, Daniela Campion, Salvatore Piano, Elisa Pose, T. Lanzillotti, Carlos Jiménez, Sara Montagnese, Patrick S. Kamath, Rajeshwar P. Mookerjee, Miquel Gómez i Serra, Ruben Hernaez, M. Aban, Marta Carol, G. Nicolao, Claire Francoz, Giacomo Zaccherini, Hugh Watson, Isabel Graupera, M.T. Chiappa, Jonel Trebicka, Macarena Simón-Talero, Frank Erhard Uschner, Cristina Solé, Alejandro Forner, Ulrich Beuers, F. Durand, Paolo Caraceni, Victor Vargas, Marta Cervera, Carlo Alessandria, Adrià Juanola, V. Esnault, Jeltje Helder, Marko Korenjak, Olivier Roux, Laura Napoleone, Ferran Torres, S. Graf-Dirmeier, Judit Pich, Ann T. Ma, Maria Martha Bernardi, M. Pérez-Guasch, Núria Fabrellas, Pere Ginès, Maricela Quintana López, Elsa Solà, Emma Avitabile, Aleksander Krag, Juan G. Abraldes, Gastroenterology and Hepatology, Graduate School, Tytgat Institute for Liver and Intestinal Research, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism, Elsa Solà, Elisa Pose, Daniela Campion, Salvatore Piano, Olivier Roux, Macarena Simon-Talero, Frank Uschner, Koos de Wit, Giacomo Zaccherini, Carlo Alessandria, Ulrich Beuers, Paolo Caraceni, Claire Francoz, Rajeshwar P. Mookerjee, Jonel Trebicka, Victor Vargas, Miquel Serra, Ferran Torres, Sara Montagnese, Aleksander Krag, Ruben Hernaez, Marko Korenjak, Hugh Watson, Juan G. Abraldes, Patrick S. Kamath, Pere Ginès, LiverHope Consortium Investigators, Institut Català de la Salut, [Solà E, Pose E] Liver Unit, Hospital Clínic De Barcelona, Barcelona, School of Medicine and Health Sciences University of Barcelona, Spain. Institut d´Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain. [Campion D] Division of Gastroenterology and Hepatology, Città della Salute e della Scienza Hospital, University of Turin, Turin, Italy. [Piano S] Unit of Internal Medicine and Hepatology (UIMH), Department of Medicine - DIMED, University of Padova, Padova, Italy. [Roux O] Hepatology and Liver Intensive Care Unit, Hospital Beaujon, APHP, Clichy, France. [Simon-Talero M] Unitat del Fetge, Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institut de Recerca (VHIR), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra, Spain. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Liver Cirrhosis, 0301 basic medicine, Cirrhosis, administración de los servicios de salud::gestión de la atención al paciente::tratamiento de las enfermedades [ATENCIÓN DE SALUD], enfermedades del sistema digestivo::enfermedades hepáticas::cirrosis hepática [ENFERMEDADES], Digestive System Diseases::Liver Diseases::Liver Cirrhosis [DISEASES], Trasplantament hepàtic, Disease, Severity of Illness Index, 0302 clinical medicine, Clinical trials, Quality of life, ACLF, Ascites, Secondary Prevention, Liver transplant, Otros calificadores::/terapia [Otros calificadores], Hepatic encephalopathy, Clinical Trials as Topic, education.field_of_study, Disease Management, 3. Good health, Clinical trial, Europe, Natural history, Hepatic cirrhosis, Research Design, Qualitat de vida, Ascite, Disease Progression, 030211 gastroenterology & hepatology, AKI, ascites, cirrhosis, clinical trials, endpoints, hepatic encephalopathy, hyponatremia, infections, liver transplant, quality of life, medicine.symptom, Infection, Hyponatremia, técnicas de investigación::métodos::diseño de la investigación [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], medicine.medical_specialty, Consensus, Cirrosi hepàtica, Endpoint Determination, Population, Infections, 03 medical and health sciences, Investigative Techniques::Methods::Research Design [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Hypertension, Portal, medicine, Humans, Intensive care medicine, education, Health Services Administration::Patient Care Management::Disease Management [HEALTH CARE], Cirrosi hepàtica - Tractament, Cirrhosi, Hepatology, business.industry, Other subheadings::/therapy [Other subheadings], Endpoint, medicine.disease, Assaigs clínics - Disseny, 030104 developmental biology, Etiology, Endpoints, business, Hepatic transplantation
Abstract

Clinical trials; Liver transplant; Quality of life Ensayos clínicos; Trasplante de hígado; Calidad de vida Assaigs clínics; Trasplantament de fetge; Qualitat de vida Management of decompensated cirrhosis is currently geared towards the treatment of complications once they occur. To date there is no established disease-modifying therapy aimed at halting progression of the disease and preventing the development of complications in patients with decompensated cirrhosis. The design of clinical trials to investigate new therapies for patients with decompensated cirrhosis is complex. The population of patients with decompensated cirrhosis is heterogeneous (i.e., different etiologies, comorbidities and disease severity), leading to the inclusion of diverse populations in clinical trials. In addition, primary endpoints selected for trials that include patients with decompensated cirrhosis are not homogeneous and at times may not be appropriate. This leads to difficulties in comparing results obtained from different trials. Against this background, the LiverHope Consortium organized a meeting of experts, the goal of which was to develop recommendations for the design of clinical trials and to define appropriate endpoints, both for trials aimed at modifying the natural history and preventing progression of decompensated cirrhosis, as well as for trials aimed at managing the individual complications of cirrhosis.

Published
2021
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