PMID- 38048934 OWN - NLM STAT- MEDLINE DCOM- 20240325 LR - 20240325 IS - 1542-7714 (Electronic) IS - 1542-3565 (Linking) VI - 22 IP - 4 DP - 2024 Apr TI - Accuracy of the Enhanced Liver Fibrosis Test in Patients With Type 2 Diabetes Mellitus and Its Clinical Implications. PG - 789-797.e8 LID - S1542-3565(23)00961-8 [pii] LID - 10.1016/j.cgh.2023.11.022 [doi] AB - BACKGROUND AND AIMS: The diagnostic performance of the Fibrosis-4 (FIB-4) index and nonalcoholic fatty liver disease (NAFLD) fibrosis score (NFS) is poor in patients with type 2 diabetes mellitus (T2DM). We determined the usefulness of the Enhanced Liver Fibrosis (ELF) test in patients with T2DM. METHODS: A total of 1228 patients with biopsy-proven NAFLD were enrolled. The diagnostic performance of the ELF test for predicting advanced fibrosis in participants with or without T2DM was evaluated in comparison with the FIB-4 index and NFS. RESULTS: Overall, the area under the curve of the ELF test for predicting advanced fibrosis was greater (0.828) than that of the FIB-4 index (0.727) and NFS (0.733). The diagnostic performance of the ELF test (area under the curve, 0.820) was also superior to that of the FIB-4 index (0.698) and NFS (0.700) in patients with T2DM. With the low cutoff values for each noninvasive test, the ELF test provided an acceptable false negative rate (cutoff value 9.8, 6.7%) in this population, unlike the FIB-4 index (1.30, 14.5%) and NFS (-1.455, 12.4%). After propensity score matching to avoid selection bias including age, sex, body mass index, and the prevalence of advanced fibrosis, the ELF test with a low cutoff value showed a high sensitivity (>/=91.4%) and a high negative predictive value (>/=96.8%), irrespective of the presence or absence of T2DM. CONCLUSIONS: The high diagnostic performance of the ELF test for predicting advanced fibrosis in individuals with or without T2DM could address an unmet medical need for accurate assessment of liver fibrosis in patients with diabetes and NAFLD. CI - Copyright (c) 2024 AGA Institute. Published by Elsevier Inc. All rights reserved. FAU - Arai, Taeang AU - Arai T AD - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan. FAU - Takahashi, Hirokazu AU - Takahashi H AD - Liver Center, Saga University Hospital, Saga, Japan. Electronic address: takahas2@cc.saga-u.ac.jp. FAU - Seko, Yuya AU - Seko Y AD - Department of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan. FAU - Toyoda, Hidenori AU - Toyoda H AD - Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital, Ogaki, Japan. FAU - Hayashi, Hideki AU - Hayashi H AD - Department of Gastroenterology and Hepatology, Gifu Municipal Hospital, Gifu, Japan. FAU - Yamaguchi, Kanji AU - Yamaguchi K AD - Department of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan. FAU - Iwaki, Michihiro AU - Iwaki M AD - Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan. FAU - Yoneda, Masato AU - Yoneda M AD - Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan. FAU - Shima, Toshihide AU - Shima T AD - Department of Gastroenterology and Hepatology, Saiseikai Suita Hospital, Osaka, Japan. FAU - Fujii, Hideki AU - Fujii H AD - Department of Hepatology, Osaka Metropolitan University, Osaka, Japan. FAU - Morishita, Asahiro AU - Morishita A AD - Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, Takamatsu, Japan. FAU - Kawata, Kazuhito AU - Kawata K AD - Hepatology Division, Department of Internal Medicine II, Hamamatsu University School of Medicine, Hamamatsu, Japan. FAU - Tomita, Kengo AU - Tomita K AD - Department of Internal Medicine, National Defense Medical College, Tokorozawa, Japan. FAU - Kawanaka, Miwa AU - Kawanaka M AD - Department of General Internal Medicine 2, Kawasaki General Medical Center, Kawasaki Medical School, Okayama, Japan. FAU - Yoshida, Yuichi AU - Yoshida Y AD - Department of Gastroenterology and Hepatology, Suita Municipal Hospital, Osaka, Japan. FAU - Ikegami, Tadashi AU - Ikegami T AD - Department of Gastroenterology and Hepatology, Tokyo Medical University Ibaraki Medical Center, Ibaraki, Japan. FAU - Notsumata, Kazuo AU - Notsumata K AD - Department of General Internal Medicine, Fukui-ken Saiseikai Hospital, Fukui, Japan. FAU - Oeda, Satoshi AU - Oeda S AD - Liver Center, Saga University Hospital, Saga, Japan. FAU - Atsukawa, Masanori AU - Atsukawa M AD - Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan. FAU - Kamada, Yoshihiro AU - Kamada Y AD - Department of Advanced Metabolic Hepatology, Osaka University Graduate School of Medicine, Osaka, Japan. FAU - Sumida, Yoshio AU - Sumida Y AD - Division of Hepatology and Pancreatology, Department of Internal Medicine, Aichi Medical University, Aichi, Japan. FAU - Fukushima, Hideaki AU - Fukushima H AD - Diagnostics Business Area, Siemens Healthcare Diagnostics K.K., Tokyo, Japan. FAU - Miyoshi, Eiji AU - Miyoshi E AD - Department of Molecular Biochemistry & Clinical Investigation, Osaka University Graduate School of Medicine, Osaka, Japan. FAU - Aishima, Shinichi AU - Aishima S AD - Department of Pathology and Microbiology, Faculty of Medicine, Saga University, Saga, Japan. FAU - Okanoue, Takeshi AU - Okanoue T AD - Department of Gastroenterology and Hepatology, Saiseikai Suita Hospital, Osaka, Japan. FAU - Itoh, Yoshito AU - Itoh Y AD - Department of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan. FAU - Nakajima, Atsushi AU - Nakajima A AD - Department of Gastroenterology and Hepatology, Yokohama City University Graduate School of Medicine, Yokohama, Japan. CN - Japan Study Group of Nonalcoholic Fatty Liver Disease (JSG-NAFLD) LA - eng PT - Journal Article DEP - 20231202 PL - United States TA - Clin Gastroenterol Hepatol JT - Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association JID - 101160775 RN - EC 2.6.1.2 (Alanine Transaminase) RN - EC 2.6.1.1 (Aspartate Aminotransferases) SB - IM MH - Humans MH - *Non-alcoholic Fatty Liver Disease/complications/diagnosis/epidemiology MH - *Diabetes Mellitus, Type 2/complications MH - Alanine Transaminase MH - Aspartate Aminotransferases MH - Liver Cirrhosis/pathology MH - Biopsy MH - Liver/pathology MH - Severity of Illness Index OTO - NOTNLM OT - Diabetes OT - ELF OT - Fibrosis OT - NAFLD OT - Noninvasive Tests EDAT- 2023/12/05 00:42 MHDA- 2024/03/25 06:43 CRDT- 2023/12/04 19:24 PHST- 2023/05/31 00:00 [received] PHST- 2023/10/05 00:00 [revised] PHST- 2023/11/20 00:00 [accepted] PHST- 2024/03/25 06:43 [medline] PHST- 2023/12/05 00:42 [pubmed] PHST- 2023/12/04 19:24 [entrez] AID - S1542-3565(23)00961-8 [pii] AID - 10.1016/j.cgh.2023.11.022 [doi] PST - ppublish SO - Clin Gastroenterol Hepatol. 2024 Apr;22(4):789-797.e8. doi: 10.1016/j.cgh.2023.11.022. Epub 2023 Dec 2.