Non-invasive risk scores do not reliably identify future cirrhosis or hepatocellular carcinoma in Type 2 diabetes: The Edinburgh type 2 diabetes study

Sheila M. Grecian*, Stela McLachlan, Jonathan A. Fallowfield, Patrick K.A. Kearns, Peter C. Hayes, Neil I. Guha, Joanne R. Morling, Stephen Glancy, Rachel M. Williamson, Rebecca M. Reynolds, Brian M. Frier, Nicola N. Zammitt, Jackie F. Price, Mark W.J. Strachan

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)

Abstract

Background: The incidence of cirrhosis and hepatocellular carcinoma (HCC) is increased in Type 2 diabetes, primarily secondary to non-alcoholic fatty liver disease (NAFLD). European guidelines recommend screening for NAFLD in Type 2 diabetes. American guidelines, while not advocating a screening protocol, suggest using non-invasive markers of fibrosis for risk-stratification and guiding onward referral. Aims: To test the ability of individual fibrosis scores and the European screening algorithm to predict 11-year incident cirrhosis/HCC in an asymptomatic community cohort of older people with Type 2 diabetes. Methods: The Edinburgh Type 2 Diabetes Study investigated men and women with Type 2 diabetes (n = 1066, aged 60–75 at baseline). Liver markers were measured at baseline and year 1; steatosis and fibrosis markers were calculated according to independently published calculations. During 11 years of follow-up, cases of cirrhosis and HCC were identified. Results: Forty-three out of 1059 participants with no baseline cirrhosis/HCC developed incident disease. All scores were significantly associated with incident liver disease by odds ratio (P <.05). The ability of the risk-stratification tools to accurately identify those who developed incident cirrhosis/HCC was poor with low-positive predictive values (5-46%) and high false-negative and -positive rates (up to 60% and 77%) respectively. When fibrosis risk scores were used in conjunction with the European algorithm, they performed modestly better than when applied in isolation. Conclusions: In a cohort with a moderately low incidence of cirrhosis/HCC, existing risk scores did not reliably identify participants at high risk. Better prediction models for cirrhosis/HCC in people with Type 2 diabetes are required.

Original languageEnglish
Pages (from-to)2252-2262
Number of pages11
JournalLiver International
Volume40
Issue number9
DOIs
Publication statusPublished - 1 Sep 2020
Externally publishedYes

Bibliographical note

Funding Information:
The Edinburgh Type 2 Diabetes Study was funded by a grant from the U.K. Medical Research Council (Project Grant G0500877) and the Chief Scientist Office of Scotland (Programme Support Grant CZQ/1/38), and the liver substudy was supported by a grant from Pfizer (Unrestricted Investigator Led Grant). The study sponsor was not involved in the design of the study; the collection, analysis and interpretation of data; writing the report; or the decision to submit the report for publication. S.M.G. wrote the manuscript. J.F.P. was principal investigator of the ETDS, designed the study, analysed and interpreted the data. M.W.J.S., was lead investigator of the liver substudy of the ET2DS, designed the study, analysed and interpreted the data. R.M.R., B.M.F., P.C.H, J.A.F, R.M.W, N.G. and S.G. contributed to study design. S.M.G., S.M., R.M.W., J.M. and P.K. contributed to data collection, analysis and interpretation.

Funding Information:
J.A.F. has received consultancy fees from Ferring Pharmaceuticals, Macrophage Pharma, Galecto Biotech, Caldan Therapeutics, Cypralis Ltd, NorthSea Therapeutics, Gilde Healthcare, Guidepoint, Techspert.ioand research grant funding from GlaxoSmithKline, Intercept Pharmaceuticals and Novartis for work unconnected with that reported in this article. J.M. reported salary funding from Diabetes UK for the ET2DS. R.M.W. reported salary funding by a research grant from Pfizer for 2 years. B.M.F. has participated in a Speakers' Bureau for: Lilly, Novo Nordisk, MSD, Sanofi, Roche, Abbott and Boehringer Ingelheim, and has served on advisory boards for Lilly, Novo Nordisk, Locemia Solutions and Zucara. M.W.J.S has received consultancy fees from Servier and Novo Nordisk and speaking fees from Napp and Eli Lilly. J.R.M. reported salary funding during the project from Diabetes UK and reports salary funding (not associated with this project) from MRC. No other potential conflicts of interest relevant to this article were reported.

Funding Information:
The Edinburgh Type 2 Diabetes Study was funded by a grant from the U.K. Medical Research Council (Project Grant G0500877) and the Chief Scientist Office of Scotland (Programme Support Grant CZQ/1/38), and the liver substudy was supported by a grant from Pfizer (Unrestricted Investigator Led Grant). The study sponsor was not involved in the design of the study; the collection, analysis and interpretation of data; writing the report; or the decision to submit the report for publication.

Publisher Copyright:
© 2020 The Authors. Liver International published by John Wiley & Sons Ltd

Keywords

  • cirrhosis
  • hepatocellular carcinoma
  • non-alcoholic fatty liver disease
  • risk prediction
  • screening
  • type 2 Diabetes

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