Portal de investigação
MASLD and MASH at the crossroads of hepatology trials and cardiorenal metabolic trials
Data de publicação:
Autores da FMUP
Participantes de fora da FMUP
- Zannad F.
- Sanyal A.J.
- Butler J.
- Girerd N.
- Miller V.
- Pandey A.
- Parikh C.R.
- Ratziu V.
- Younossi Z.M.
- Harrison S.A.
Unidades de investigação
Abstract
Steatotic liver disease (SLD) is a worldwide public health problem, causing considerable morbidity and mortality. Patients with SLD are at increased risk for major adverse cardiovascular (CV) events, type 2 diabetes mellitus and chronic kidney disease. Conversely, patients with cardiometabolic conditions have a high prevalence of SLD. In addition to epidemiological evidence linking many of these conditions, there is evidence of shared pathophysiological processes. In December 2022, a unique multi-stakeholder, multi-specialty meeting, called MOSAIC (Metabolic multi Organ Science Accelerating Innovation in Clinical Trials) was convened to foster collaboration across metabolic, hepatology, nephrology and CV disorders. One of the goals of the meeting was to consider approaches to drug development that would speed regulatory approval of treatments for multiple disorders by combining liver and cardiorenal endpoints within a single study. Non-invasive tests, including biomarkers and imaging, are needed in hepatic and cardiorenal trials. They can be used as trial endpoints, to enrich trial populations, to diagnose and risk stratify patients and to assess treatment efficacy and safety. Although they are used in proof of concept and phase 2 trials, they are often not acceptable for regulatory approval of therapies. The challenge is defining the optimal combination of biomarkers, imaging and morbidity/mortality outcomes and ensuring that they are included in future trials while minimizing the burden on patients, trialists and trial sponsors. This paper provides an overview of some of the wide array of CV, liver and kidney measurements that were discussed at the MOSAIC meeting. © 2024 The Association for the Publication of the Journal of Internal Medicine.
Dados da publicação
- ISSN/ISSNe:
- 0954-6820, 1365-2796
- Tipo:
- Review
- Páginas:
- 24-38
- DOI:
- 10.1111/joim.13793
- Link para outro recurso:
- www.scopus.com
Journal of Internal Medicine Wiley-Blackwell Publishing Ltd
Citações Recebidas na Scopus: 3
Documentos
- Não há documentos
Filiações
Keywords
- Biomarkers; Cardiovascular Diseases; Clinical Trials as Topic; Diabetes Mellitus, Type 2; Fatty Liver; Humans; Renal Insufficiency, Chronic; biological marker; awareness; cardiorenal syndrome; chronic kidney failure; clinical trial (topic); epidemiology; global disease burden; human; metabolic fatty liver; non insulin dependent diabetes mellitus; Review; cardiovascular disease; complication; drug therapy; fatty liver; therapy
Proyectos asociados
Dapagliflozin, Spironolactone or Both for HFpEF (SOGALDI-PEF) - NCT05676684
Investigador Principal: João Pedro Melo Marques Pinho Ferreira
Ensaio Clínico Académico (SOGALDI-PEF) . AstraZeneca . 2022
Initiation of ARNi and SGLT2i in Patients With HFrEF: Randomized Open-label Trial (INITIATE-HFrEF) -NCT05989503
Investigador Principal: João Pedro Melo Marques Pinho Ferreira
Ensaio Clínico Académico (INITIATE-HFrEF) . Novartis . 2023
Citar a publicação
Zannad F,Sanyal AJ,Butler J,Ferreira JP,Girerd N,Miller V,Pandey A,Parikh CR,Ratziu V,Younossi ZM,Harrison SA. MASLD and MASH at the crossroads of hepatology trials and cardiorenal metabolic trials. J. Intern. Med. (GBR). 2024. 296(1):p. 24-38. IF:11,100. (1).
