Low frequencies of lifestyle interventions and liver-specific medications in a multicentric prospective real world NAFLD cohort: The fatty liver assessment in Germany (FLAG) study

Nonalcoholic fatty liver disease (NAFLD) affects approximately 25% of the German population. However, there is only limited knowledge about the prevalence of NAFLD with advanced fibrosis, the frequencies of lifestyle interventions and the use of available medications that may have a beneficial effects on comorbidities and NAFLD. Cohort studies in a “real life” setting represent a suitable tool to study clinical outcomes in patients with NAFLD and assess standards of health care.

The fatty liver assessment in Germany (FLAG) study is a prospective, multicentric cohort study initiated by BNG in cooperation with University Hospitals and the German Liver Foundation. Patients characteristics as well as laboratory parameters that allow calculation of non-commercial, non-invasive liver fibrosis scores are collected. Liver stiffness measurement (LSM) data are included when available. Lifestyle interventions, medications, and clinical events are assessed at baseline and followed-up prospectively.

Baseline data from the first 400 Patients with NAFLD were analyzed including 52% men (mean age 52 years). By calculating FIB-4 index, 9.4% of patients had advanced fibrosis (F3-F4 fibrosis). Accordingly, those with F3-F4 fibrosis had higher mean LSM (14,1 kPa vs. 8.1 kPa) values as compared to patients with no advanced fibrosis. Type 2 diabetes mellitus (T2DM), arterial hypertension, and a history of cardiovascular events were more frequent in those with F3-F4 fibrosis as compared to patients without advanced fibrosis (47%, 89%, and 19% vs. 19%, 44%, and 14%, respectively; p< 0.02 for T2DM and arterial hypertension, respectively). In 17% of the patients, any NAFLD medical intervention was recorded including vitamin E, vitamin D, UDCA, and silymarin, respectively. Nutritional counselling took place in 28% of the patients and 15% of the patients reported physical activity at least 2 time per week.

In this multicentric prospective cohort study, baseline data of patients with NAFLD give insights in the real world patient care in Germany. There is a low frequency and heterogeneity in use of available medications that may affect NAFLD outcome. Lifestyle interventions should be strenghtend and their effectiveness will be assessed during prospective data collection.