A roadmap for clinical trials in MASH-related compensated cirrhosis

Rinella, M. E. et al. A multi-society Delphi consensus statement on new fatty liver disease nomenclature. J. Hepatol. 79, 1542–1556 (2023).

Article  CAS  PubMed  Google Scholar 

Younossi, Z. et al. Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat. Rev. Gastroenterol. Hepatol. 15, 11–20 (2018).

Article  PubMed  Google Scholar 

Brown, G. T. & Kleiner, D. E. Histopathology of nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. Metabolism 65, 1080–1086 (2016).

Article  CAS  PubMed  Google Scholar 

Anstee, Q. M., Reeves, H. L., Kotsiliti, E., Govaere, O. & Heikenwalder, M. From NASH to HCC: current concepts and future challenges. Nat. Rev. Gastroenterol. Hepatol. 16, 411–428 (2019).

Article  PubMed  Google Scholar 

Estes, C., Razavi, H., Loomba, R., Younossi, Z. & Sanyal, A. J. Modeling the epidemic of nonalcoholic fatty liver disease demonstrates an exponential increase in burden of disease. Hepatology 67, 123–133 (2018).

Article  CAS  PubMed  Google Scholar 

Estes, C. et al. Modeling NAFLD disease burden in China, France, Germany, Italy, Japan, Spain, United Kingdom, and United States for the period 2016-2030. J. Hepatol. 69, 896–904 (2018).

Article  PubMed  Google Scholar 

Younossi, Z. M. et al. The global epidemiology of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH): a systematic review. Hepatology 77, 1335–1347 (2023).

Article  PubMed  Google Scholar 

Huang, D. Q. et al. Global epidemiology of cirrhosis — aetiology, trends and predictions. Nat. Rev. Gastroenterol. Hepatol. 20, 388–398 (2023).

Article  PubMed  PubMed Central  Google Scholar 

Huang, D. Q., El-Serag, H. B. & Loomba, R. Global epidemiology of NAFLD-related HCC: trends, predictions, risk factors and prevention. Nat. Rev. Gastroenterol. Hepatol. 18, 223–238 (2021).

Article  PubMed  Google Scholar 

Francque, S. et al. Nonalcoholic steatohepatitis: the role of peroxisome proliferator-activated receptors. Nat. Rev. Gastroenterol. Hepatol. 18, 24–39 (2021).

Article  PubMed  Google Scholar 

Haas, J. T., Francque, S. & Staels, B. Pathophysiology and mechanisms of nonalcoholic fatty liver disease. Annu. Rev. Physiol. 78, 181–205 (2016).

Article  CAS  PubMed  Google Scholar 

Francque, S. & Vonghia, L. Pharmacological treatment for non-alcoholic fatty liver disease. Adv. Ther. 36, 1052–1107 (2019).

Article  CAS  PubMed  PubMed Central  Google Scholar 

Lefere, S. & Tacke, F. Macrophages in obesity and non-alcoholic fatty liver disease: crosstalk with metabolism. JHEP Rep. 1, 30–43 (2019).

Article  PubMed  PubMed Central  Google Scholar 

Gastaldelli, A. & Cusi, K. From NASH to diabetes and from diabetes to NASH: mechanisms and treatment options. JHEP Rep. 1, 312–328 (2019).

Article  PubMed  PubMed Central  Google Scholar 

Wree, A., Broderick, L., Canbay, A., Hoffman, H. M. & Feldstein, A. E. From NAFLD to NASH to cirrhosis-new insights into disease mechanisms. Nat. Rev. Gastroenterol. Hepatol. 10, 627–636 (2013).

Article  CAS  PubMed  Google Scholar 

Cheung, A. et al. Defining improvement in nonalcoholic steatohepatitis for treatment trial endpoints: recommendations from the liver forum. Hepatology 70, 1841–1855 (2019).

Article  PubMed  Google Scholar 

Rinella, M. E., Tacke, F., Sanyal, A. J. & Anstee, Q. M. Report on the AASLD/EASL joint workshop on clinical trial endpoints in NAFLD. J. Hepatol. 71, 823–833 (2019).

Article  PubMed  Google Scholar 

Ratziu, V., Francque, S. & Sanyal, A. Breakthroughs in therapies for NASH and remaining challenges. J. Hepatol. 76, 1263–1278 (2022).

Article  CAS  PubMed  Google Scholar 

Harrison, S. A. et al. A phase 3, randomized, controlled trial of resmetirom in NASH with liver fibrosis. N. Engl. J. Med. 390, 497–509 (2024).

Article  PubMed  Google Scholar 

FDA. FDA Approves First Treatment for Patients with Liver Scarring due to Fatty Liver Disease, March 14 2024 https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-patients-liver-scarring-due-fatty-liver-disease (2024).

Francque, S. & Ratziu, V. Future treatment options and regimens for nonalcoholic fatty liver disease. Clin. Liver Dis. 27, 429–444 (2023).

Article  PubMed  Google Scholar 

Cusi, K. et al. American Association of Clinical Endocrinology clinical practice guideline for the diagnosis and management of nonalcoholic fatty liver disease in primary care and endocrinology clinical settings: co-sponsored by the American Association for the Study of Liver Diseases (AASLD). Endocr. Pract. 28, 528–562 (2022).

Article  PubMed  Google Scholar 

Friedman, S. L., Neuschwander-Tetri, B. A., Rinella, M. & Sanyal, A. J. Mechanisms of NAFLD development and therapeutic strategies. Nat. Med. 24, 908–922 (2018).

Article  CAS  PubMed  PubMed Central  Google Scholar 

Sanyal, A. J. et al. Prospective study of outcomes in adults with nonalcoholic fatty liver disease. N. Engl. J. Med. 385, 1559–1569 (2021).

Article  CAS  PubMed  PubMed Central  Google Scholar 

Allen, A. M. et al. Clinical course of non-alcoholic fatty liver disease and the implications for clinical trial design. J. Hepatol. 77, 1237–1245 (2022).

Article  CAS  PubMed  PubMed Central  Google Scholar 

Rinella, M. E. et al. AASLD practice guidance on the clinical assessment and management of nonalcoholic fatty liver disease. Hepatology 77, 1797–1835 (2023).

Article  PubMed  Google Scholar 

Younossi, Z. M., Zelber-Sagi, S., Henry, L. & Gerber, L. H. Lifestyle interventions in nonalcoholic fatty liver disease. Nat. Rev. Gastroenterol. Hepatol. 20, 708–722 (2023).

Article  CAS  PubMed  Google Scholar 

Tacke, F. et al. Updated S2k clinical practice guideline on non-alcoholic fatty liver disease (NAFLD) issued by the German Society of Gastroenterology, digestive and metabolic diseases (DGVS). Z. Gastroenterol. 60, E733–E801 (2022).

Article  Google Scholar 

Fayad, L. et al. Endoscopic sleeve gastroplasty versus laparoscopic sleeve gastrectomy: a case-matched study. Gastrointest. Endosc. 89, 782–788 (2019).

Article  PubMed  Google Scholar 

Aminian, A. et al. Association of bariatric surgery with major adverse liver and cardiovascular outcomes in patients with biopsy-proven nonalcoholic steatohepatitis. JAMA 326, 2031–2042 (2021).

Article  PubMed  PubMed Central  Google Scholar 

Wilding, J. P. H. et al. Once-weekly semaglutide in adults with overweight or obesity. N. Engl. J. Med. 384, 989–1002 (2021).

Article  CAS  PubMed  Google Scholar 

Jastreboff, A. M. et al. Tirzepatide once weekly for the treatment of obesity. N. Engl. J. Med. 387, 205–216 (2022).

Article  CAS  PubMed  Google Scholar 

Loomba, R. et al. Semaglutide 2.4 mg once weekly in patients with non-alcoholic steatohepatitis-related cirrhosis: a randomised, placebo-controlled phase 2 trial. Lancet Gastroenterol. Hepatol. 8, 511–522 (2023).

Article  PubMed  PubMed Central  Google Scholar 

留言 (0)

沒有登入
gif