A Retrospective Cohort Study Evaluating the Association Between Fibrosis-4 Index and Major Adverse Cardiovascular Events in Patients with Metabolic Dysfunction-Associated Steatohepatitis
Author(s)
Semiu O. Gbadamosi, MPH, PhD, MD1, Abdalla Aly, PhD2, Chi Nguyen, PhD2, Aidan McGovern, PhD3, Anthony Hoovler, PhD4;
1Novo Nordisk Inc., Real-World Evidence, Clinical Data Science and Evidence, Plainsboro, NJ, USA, 2Novo Nordisk Inc, Real-World Evidence, Clinical Data Science and Evidence, Plainsboro, NJ, USA, 3Novo Nordisk, HEOR Evidence Strategy & Synthesis, Plainsboro, NJ, USA, 4Novo Nordisk Inc, Medical Affairs, Plainsboro, NJ, USA
1Novo Nordisk Inc., Real-World Evidence, Clinical Data Science and Evidence, Plainsboro, NJ, USA, 2Novo Nordisk Inc, Real-World Evidence, Clinical Data Science and Evidence, Plainsboro, NJ, USA, 3Novo Nordisk, HEOR Evidence Strategy & Synthesis, Plainsboro, NJ, USA, 4Novo Nordisk Inc, Medical Affairs, Plainsboro, NJ, USA
Presentation Documents
OBJECTIVES: The cardiovascular burden in patients with metabolic dysfunction-associated steatohepatitis (MASH) is significant, particularly in patients with advanced fibrosis. Fibrosis-4 (FIB-4) index is a non-invasive test that is used to estimate the risk of advanced fibrosis. This study aimed to quantify the relationship between the FIB-4 score and the risk for developing major adverse cardiovascular events (MACE) among patients with MASH.
METHODS: This retrospective cohort study used Optum’s de-identified Clinformatics® Data Mart Database to identify adult patients (≥18 years) newly diagnosed with MASH (index date) from 10/01/2016 to 09/30/2022. The FIB-4 score within ±90 days of the index date was calculated, and patients were categorized into low (<1.30), indeterminate (1.30-2.67), or high (>2.67) risk groups. An expanded MACE outcome defined as any occurrence of non-fatal acute myocardial infarction (MI), non-fatal ischemic stroke (IS), coronary revascularization (CR), heart failure (HF) hospitalization, or all-cause mortality was assessed. Unadjusted risk ratios (RR) and 95% confidence intervals (CI) were calculated at 2 years for MACE (composite and individual) events.
RESULTS: Among 11,987 patients with MASH, 42%, 31.9%, and 26.1% had low, indeterminate, and high FIB-4 scores, respectively. At 2-year follow-up, the incidence of MACE was highest in the high-risk group (12.0%) relative to the indeterminate (7.3%) and low-risk groups (3.9%). Patients in the high-risk group had higher risks for MACE (RR: 3.09; 95% CI: 2.39, 4.00), MI (1.83; 1.02, 3.27), IS (2.41; 1.41, 4.18), CR (2.07; 1.31, 3.28) and HF hospitalization (5.48; 3.60, 8.55) compared to the low-risk group. Similar associations were observed when comparing the indeterminate to the low-risk group, except for MI outcomes.
CONCLUSIONS: Patients with high FIB-4 scores had significantly higher risks for cardiovascular events compared to patients with low scores, suggesting that advanced fibrosis may serve as an independent risk factor for cardiovascular morbidity.
METHODS: This retrospective cohort study used Optum’s de-identified Clinformatics® Data Mart Database to identify adult patients (≥18 years) newly diagnosed with MASH (index date) from 10/01/2016 to 09/30/2022. The FIB-4 score within ±90 days of the index date was calculated, and patients were categorized into low (<1.30), indeterminate (1.30-2.67), or high (>2.67) risk groups. An expanded MACE outcome defined as any occurrence of non-fatal acute myocardial infarction (MI), non-fatal ischemic stroke (IS), coronary revascularization (CR), heart failure (HF) hospitalization, or all-cause mortality was assessed. Unadjusted risk ratios (RR) and 95% confidence intervals (CI) were calculated at 2 years for MACE (composite and individual) events.
RESULTS: Among 11,987 patients with MASH, 42%, 31.9%, and 26.1% had low, indeterminate, and high FIB-4 scores, respectively. At 2-year follow-up, the incidence of MACE was highest in the high-risk group (12.0%) relative to the indeterminate (7.3%) and low-risk groups (3.9%). Patients in the high-risk group had higher risks for MACE (RR: 3.09; 95% CI: 2.39, 4.00), MI (1.83; 1.02, 3.27), IS (2.41; 1.41, 4.18), CR (2.07; 1.31, 3.28) and HF hospitalization (5.48; 3.60, 8.55) compared to the low-risk group. Similar associations were observed when comparing the indeterminate to the low-risk group, except for MI outcomes.
CONCLUSIONS: Patients with high FIB-4 scores had significantly higher risks for cardiovascular events compared to patients with low scores, suggesting that advanced fibrosis may serve as an independent risk factor for cardiovascular morbidity.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
RWD29
Topic
Real World Data & Information Systems
Disease
SDC: Diabetes/Endocrine/Metabolic Disorders (including obesity)