Assessing Cardiovascular Disease (CVD) Risk By Fibrosis Stage Defined By Fibrosis-4 (FIB-4) Among Patients with Non-Alcoholic Steatohepatitis (NASH) Using Real World Data (RWD)


Bogdanov A1, Fishman J2, Dodge S2, Miller K2, Zeng N3, Bonafede M4
1Veradigm Life Sciences, san francisco, CA, USA, 2Madrigal Pharmaceuticals, West Conshohocken, PA, USA, 3Veradigm Life Sciences, Chicago, IL, USA, 4Veradigm Life Sciences, Brentwood, NH, USA

OBJECTIVES: Accumulating evidence has shown that NASH is related to increased risk of death caused by CVD, but little is known about the association between fibrosis stage and CVD. This study assessed CVD risk in NASH patients by fibrosis stage using a large real-world database.

METHODS: The Veradigm Health Insights Electronic Health Record Database and linked Komodo administrative claims data was used to identify adults with a NASH diagnosis code to evaluate their fibrosis stages as well as CVD risk. The index date was the earliest NASH diagnosis recorded between 2016 and 2020 with at least 6 months of database activity and continuous enrollment pre- and post-encounter. Fibrosis stage was defined using FIB-4 scores (F0/1: FIB-4≤0.95, F2: 0.95<FIB-4≤2.67, F3: 2.67<FIB-4≤4.12, F4: FIB-4>4.12). CVD risk during pre- or post-index periods was evaluated using the CVD score in accordance with the 2013 ACC-AHA guidelines.

RESULTS: Of the 6,734 patients who had a NASH diagnosis and FIB-4, 2,282 and 2,299 were identified to have a valid CVD score during pre- and post-index periods (mean score = 14.3% and 14.9%, SD = 0.15 and 0.16). During pre-index period, mean CVD scores increased progressively from patients at F0/1 stage (6.9%, n=810, SD=0.10) to those at F2 (16.8%, n=1,177, SD=0.15), F3 (21.8%, n=156, SD=0.17) and F4 (27.2%, n=139, SD=0.19). Similar trends were observed in post-index period where there was a 2.3-fold difference between patients with F2 versus F0/1. Analysis of the individual components for CVD score indicated that age and diabetes status are the two largest contributing factors. Use of related medications also increased with advancing fibrosis stage, including antidiabetics, antihypertensives, and lipid-lowering medications.

CONCLUSIONS: NASH patients with more advanced fibrosis stage possess a substantially higher CVD risk. While clinical validation is needed, addressing NASH may also reduce the risk and burden of CVD.

Conference/Value in Health Info

2022-05, ISPOR 2022, Washington, DC, USA




Epidemiology & Public Health, Study Approaches

Topic Subcategory

Disease Classification & Coding, Electronic Medical & Health Records


Cardiovascular Disorders

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