TY - JOUR
T1 - Fibrosis Progression Rate in Biopsy-Proven Nonalcoholic Fatty Liver Disease Among People With Diabetes Versus People Without Diabetes
T2 - A Multicenter Study
AU - NASH Clinical Research Network
AU - Huang, Daniel Q.
AU - Wilson, Laura A.
AU - Behling, Cynthia
AU - Kleiner, David E.
AU - Kowdley, Kris V.
AU - Dasarathy, Srinivasan
AU - Amangurbanova, Maral
AU - Terrault, Norah A.
AU - Diehl, Anna Mae
AU - Chalasani, Naga
AU - Neuschwander-Tetri, Brent A.
AU - Sanyal, Arun J.
AU - Tonascia, James
AU - Allende, Daniela
AU - Bellar, Annette
AU - Dasarathy, Jaividhya
AU - Welch, Nicole
AU - Yerrapothu, Rahul
AU - Bashir, Mustafa
AU - Guy, Cynthia
AU - Kopping, Mariko
AU - Piercy, Dawn
AU - Suzuki, Ayako
AU - Tawadrou, Naglaa
AU - Cruz, Mandy
AU - Cummings, Oscar W.
AU - Garrison, Lisa
AU - Gawrieh, Samer
AU - Samala, Niharika
AU - Vuppalanchi, Raj
AU - Carpenter, Danielle
AU - Cattoor, Theresa
AU - Freebersyser, Janet
AU - Angkanaworakul, Pannapat
AU - Berihun, Achashman
AU - Buysse, Andrew
AU - Dorrian, Theresa
AU - Gulati, Breanna
AU - Liu, Kevin
AU - Misic, Sandra
AU - Sohal, Adam
AU - Vuong, Joseph
AU - Ajmera, Veeral
AU - Loomba, Rohit
AU - Madamba, Egbert
AU - Middleton, Michael S.
AU - Richards, Lisa
AU - Singh, Seema
AU - Asgharpour, Amon
AU - Smith, Michael
N1 - Publisher Copyright:
© 2023 AGA Institute
PY - 2023/8
Y1 - 2023/8
N2 - Background & Aims: There are limited data regarding fibrosis progression in biopsy-proven nonalcoholic fatty liver disease (NAFLD) in people with type 2 diabetes mellitus (T2DM) compared with people without T2DM. We assessed the time to fibrosis progression in people with T2DM compared with people without T2DM in a large, multicenter, study of people with NAFLD who had paired liver biopsies. Methods: This study included 447 adult participants (64% were female) with NAFLD who had paired liver biopsies more than 1 year apart. Liver histology was systematically assessed by a central pathology committee blinded to clinical data. The primary outcome was the cumulative incidence of a ≥1-stage increase in fibrosis in participants with T2DM compared with participants without T2DM. Results: The mean (SD) age and body mass index (calculated as weight in kilograms divided by the square of the height in meters) were 50.9 (11.5) years and 34.7 (6.3), respectively. The median time between biopsies was 3.3 years (interquartile range, 1.8–6.1 years). Participants with T2DM had a significantly higher cumulative incidence of fibrosis progression at 4 years (24% vs 20%), 8 years (60% vs 50%), and 12 years (93% vs 76%) (P = .005). Using a multivariable Cox proportional hazards model adjusted for multiple confounders, T2DM remained an independent predictor of fibrosis progression (adjusted hazard ratio, 1.69; 95% CI, 1.17–2.43; P = .005). The cumulative incidence of fibrosis regression by ≥1 stage was similar in participants with T2DM compared with participants without T2DM (P = .24). Conclusions: In this large, multicenter cohort study of well-characterized participants with NAFLD and paired liver biopsies, we found that fibrosis progressed faster in participants with T2DM compared with participants without T2DM. These data have important implications for clinical practice and trial design.
AB - Background & Aims: There are limited data regarding fibrosis progression in biopsy-proven nonalcoholic fatty liver disease (NAFLD) in people with type 2 diabetes mellitus (T2DM) compared with people without T2DM. We assessed the time to fibrosis progression in people with T2DM compared with people without T2DM in a large, multicenter, study of people with NAFLD who had paired liver biopsies. Methods: This study included 447 adult participants (64% were female) with NAFLD who had paired liver biopsies more than 1 year apart. Liver histology was systematically assessed by a central pathology committee blinded to clinical data. The primary outcome was the cumulative incidence of a ≥1-stage increase in fibrosis in participants with T2DM compared with participants without T2DM. Results: The mean (SD) age and body mass index (calculated as weight in kilograms divided by the square of the height in meters) were 50.9 (11.5) years and 34.7 (6.3), respectively. The median time between biopsies was 3.3 years (interquartile range, 1.8–6.1 years). Participants with T2DM had a significantly higher cumulative incidence of fibrosis progression at 4 years (24% vs 20%), 8 years (60% vs 50%), and 12 years (93% vs 76%) (P = .005). Using a multivariable Cox proportional hazards model adjusted for multiple confounders, T2DM remained an independent predictor of fibrosis progression (adjusted hazard ratio, 1.69; 95% CI, 1.17–2.43; P = .005). The cumulative incidence of fibrosis regression by ≥1 stage was similar in participants with T2DM compared with participants without T2DM (P = .24). Conclusions: In this large, multicenter cohort study of well-characterized participants with NAFLD and paired liver biopsies, we found that fibrosis progressed faster in participants with T2DM compared with participants without T2DM. These data have important implications for clinical practice and trial design.
KW - Cirrhosis
KW - NAFLD
KW - Nonalcoholic Steatohepatitis
KW - Type 2 Diabetes Mellitus
UR - http://www.scopus.com/inward/record.url?scp=85162915650&partnerID=8YFLogxK
U2 - 10.1053/j.gastro.2023.04.025
DO - 10.1053/j.gastro.2023.04.025
M3 - Article
C2 - 37127100
AN - SCOPUS:85162915650
SN - 0016-5085
VL - 165
SP - 463-472.e5
JO - Gastroenterology
JF - Gastroenterology
IS - 2
ER -