Background and Aims:
Non-alcoholic fatty liver disease (NAFLD) affects approximately 25% of the German population. The identification of those patients who have advanced liver disease and need (life-style) interventions is critical. The recommended non-invasive diagnostic measures that are proposed in national and international guidelines have not been validated in a German real-world cohort so far.
Patients & Methods:
The Fatty Liver Assessment in Germany (FLAG) study is a prospective, multicentric cohort study initiated by German gastroenterologists in private practice (BNG) together with academic medical centers. Patients are recruited since February 2018. Data collection is performed with an electronic case report form, and data quality is analysed by plausibility checks and off-site monitoring. Patients characteristics and laboratory parameters that allow calculation of non-commercial, non-invasive liver fibrosis scores are collected. Liver stiffness measurements (LSM) are obtained by transient elastography. Blood samples for genetic profiling are collected centrally. Clinical events are assessed at baseline and are followed-up prospectively.
Results:
Since February 2018, 184 patients (women 49%, mean age 53 years) with NAFLD have been included. According to non-invasive serum fibrosis scores (NAFLD fibrosis score), 6% of patients presented with advanced fibrosis. Those with advanced fibrosis had higher BMI (32 kg/m2 vs. 30 kg/m2), higher AST (66 U/l vs. 43 U/l) and higher gamma-GT activities (277 U/l vs. 98 U/l), larger waist circumferences (109 cm vs. 105 cm) and higher LSM (15.7 kPa vs. 8.4 kPa) as compared to patients without advanced fibrosis. Arterial hypertension (90% vs. 51%), type 2 diabetes (73% vs. 23%), and history of cardiovascular events (9% vs. 3%) were more frequent in the fibrosis group as compared to those without advanced fibrosis.
Discussion:
In this multicentric prospective cohort study, baseline data of patients with NAFLD provided key insights in the real-world utility of non-invasive fibrosis markers that can identify patients at risk for advanced liver disease and cardiovascular morbidity. Profound patient profiling and prospective data collection on the long-term clinical outcome of this national NAFLD cohort will be presented.
