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Prospective Study of Outcomes in Adults with Nonalcoholic Fatty Liver Disease.

Publication ,  Journal Article
Sanyal, AJ; Van Natta, ML; Clark, J; Neuschwander-Tetri, BA; Diehl, A; Dasarathy, S; Loomba, R; Chalasani, N; Kowdley, K; Hameed, B; Wilson, LA ...
Published in: N Engl J Med
October 21, 2021

BACKGROUND: The prognoses with respect to mortality and hepatic and nonhepatic outcomes across the histologic spectrum of nonalcoholic fatty liver disease (NAFLD) are not well defined. METHODS: We prospectively followed a multicenter patient population that included the full histologic spectrum of NAFLD. The incidences of death and other outcomes were compared across baseline histologic characteristics. RESULTS: A total of 1773 adults with NAFLD were followed for a median of 4 years. All-cause mortality increased with increasing fibrosis stages (0.32 deaths per 100 person-years for stage F0 to F2 [no, mild, or moderate fibrosis], 0.89 deaths per 100 persons-years for stage F3 [bridging fibrosis], and 1.76 deaths per 100 person-years for stage F4 [cirrhosis]). The incidence of liver-related complications per 100 person-years increased with fibrosis stage (F0 to F2 vs. F3 vs. F4) as follows: variceal hemorrhage (0.00 vs. 0.06 vs. 0.70), ascites (0.04 vs. 0.52 vs. 1.20), encephalopathy (0.02 vs. 0.75 vs. 2.39), and hepatocellular cancer (0.04 vs. 0.34 vs. 0.14). As compared with patients with stage F0 to F2 fibrosis, patients with stage F4 fibrosis also had a higher incidence of type 2 diabetes (7.53 vs. 4.45 events per 100 person-years) and a decrease of more than 40% in the estimated glomerular filtration rate (2.98 vs. 0.97 events per 100 person-years). The incidence of cardiac events and nonhepatic cancers were similar across fibrosis stages. After adjustment for age, sex, race, diabetes status, and baseline histologic severity, the incidence of any hepatic decompensation event (variceal hemorrhage, ascites, or encephalopathy) was associated with increased all-cause mortality (adjusted hazard ratio, 6.8; 95% confidence interval, 2.2 to 21.3). CONCLUSIONS: In this prospective study involving patients with NAFLD, fibrosis stages F3 and F4 were associated with increased risks of liver-related complications and death. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; NAFLD DB2 ClinicalTrials.gov number, NCT01030484.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

October 21, 2021

Volume

385

Issue

17

Start / End Page

1559 / 1569

Location

United States

Related Subject Headings

  • Severity of Illness Index
  • Prospective Studies
  • Prognosis
  • Non-alcoholic Fatty Liver Disease
  • Middle Aged
  • Male
  • Liver Neoplasms
  • Liver Cirrhosis
  • Liver
  • Incidence
 

Citation

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Sanyal, A. J., Van Natta, M. L., Clark, J., Neuschwander-Tetri, B. A., Diehl, A., Dasarathy, S., … NASH Clinical Research Network (CRN). (2021). Prospective Study of Outcomes in Adults with Nonalcoholic Fatty Liver Disease. N Engl J Med, 385(17), 1559–1569. https://doi.org/10.1056/NEJMoa2029349
Sanyal, Arun J., Mark L. Van Natta, Jeanne Clark, Brent A. Neuschwander-Tetri, AnnaMae Diehl, Srinivasan Dasarathy, Rohit Loomba, et al. “Prospective Study of Outcomes in Adults with Nonalcoholic Fatty Liver Disease.N Engl J Med 385, no. 17 (October 21, 2021): 1559–69. https://doi.org/10.1056/NEJMoa2029349.
Sanyal AJ, Van Natta ML, Clark J, Neuschwander-Tetri BA, Diehl A, Dasarathy S, et al. Prospective Study of Outcomes in Adults with Nonalcoholic Fatty Liver Disease. N Engl J Med. 2021 Oct 21;385(17):1559–69.
Sanyal, Arun J., et al. “Prospective Study of Outcomes in Adults with Nonalcoholic Fatty Liver Disease.N Engl J Med, vol. 385, no. 17, Oct. 2021, pp. 1559–69. Pubmed, doi:10.1056/NEJMoa2029349.
Sanyal AJ, Van Natta ML, Clark J, Neuschwander-Tetri BA, Diehl A, Dasarathy S, Loomba R, Chalasani N, Kowdley K, Hameed B, Wilson LA, Yates KP, Belt P, Lazo M, Kleiner DE, Behling C, Tonascia J, NASH Clinical Research Network (CRN). Prospective Study of Outcomes in Adults with Nonalcoholic Fatty Liver Disease. N Engl J Med. 2021 Oct 21;385(17):1559–1569.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

October 21, 2021

Volume

385

Issue

17

Start / End Page

1559 / 1569

Location

United States

Related Subject Headings

  • Severity of Illness Index
  • Prospective Studies
  • Prognosis
  • Non-alcoholic Fatty Liver Disease
  • Middle Aged
  • Male
  • Liver Neoplasms
  • Liver Cirrhosis
  • Liver
  • Incidence