Prospective study of results in adults with non-alcoholic fatty liver disease

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N Engl J Med. 2021 Oct 21; 385 (17): 1559-1569. doi: 10.1056 / NEJMoa2029349.

ABSTRACT

BACKGROUND: The prognoses for hepatic and non-hepatic mortality and outcomes across the histologic spectrum of non-alcoholic 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 findings were compared between baseline histologic features.

RESULTS: A total of 1,773 adults with NAFLD were followed for a median of 4 years. All-cause mortality increased with increasing stages of fibrosis (0.32 deaths per 100 person-years for stages F0 to F2 [no, mild, or moderate fibrosis], 0.89 deaths per 100 person-years for stage F3 [bridging fibrosis], and 1.76 deaths per 100 person-years for stage F4 [cirrhosis]). The incidence of hepatic complications per 100 person-years increased with the stage of fibrosis (F0 to F2 vs F3 vs F4) as follows: varicose 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). 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 more than 40% of the estimated glomerular filtration. rate (2.98 versus 0.97 events per 100 person-years). The incidence of cardiac events and non-hepatic cancers was similar across all stages of fibrosis. After adjustment for age, sex, race, diabetic status and initial histologic severity, the incidence of any hepatic decompensation event (varicose hemorrhage, ascites or encephalopathy) was associated with an increase in all-cause mortality (adjusted risk ratio, 6.8; 95% confidence interval, 2.2 to 21.3).

CONCLUSIONS: In this prospective study involving patients with NAFLD, F3 and F4 fibrosis stages were associated with increased risks of hepatic complications and death. (Funded by the National Institute of Diabetes, Digestive and Kidney Diseases and others; NAFLD number DB2 ClinicalTrials.gov, NCT01030484.).

PMID: 34670043 | DOI: 10.1056 / NEJMoa2029349


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