Abstract
Background & AimsNAFLD is a growing health concern. The aim of the Fatty Liver Assessment in Germany (FLAG) study was to assess disease burden and provide data on the standard of care from secondary care.MethodsThe FLAG study is an observational real-world study in patients with NAFLD enrolled at 13 centres across Germany. Severity of disease was assessed by non-invasive surrogate scores and data recorded at baseline and 12 months.ResultsIn this study, 507 patients (mean age 53 years; 47% women) were enrolled. According to fibrosis-4 index, 64%, 26%, and 10% of the patients had no significant fibrosis, indeterminate stage, and advanced fibrosis, respectively. Patients with advanced fibrosis were older, had higher waist circumferences, and higher aspartate aminotransferase and gamma-glutamyltransferase as well as ferritin levels. The prevalence of obesity, arterial hypertension, and type 2 diabetes increased with fibrosis stages. Standard of care included physical exercise >2 times per week in 17% (no significant fibrosis), 19% (indeterminate), and 6% (advanced fibrosis) of patients. Medication with either vitamin E, silymarin, or ursodeoxycholic acid was reported in 5%. Approximately 25% of the patients received nutritional counselling. According to the FibroScan-AST score, 17% of patients presented with progressive non-alcoholic steatohepatitis (n = 107). On follow-up at year 1 (n = 117), weight loss occurred in 47% of patients, of whom 17% lost more than 5% of body weight. In the weight loss group, alanine aminotransferase activities were reduced by 20%.ConclusionsThis is the first report on NAFLD from a secondary-care real-world cohort in Germany. Every 10th patient presented with advanced fibrosis at baseline. Management consisted of best supportive care and lifestyle recommendations. The data highlight the urgent need for systematic health agenda in NAFLD patients.Lay summaryFLAG is a real-world cohort study that examined the liver disease burden in secondary and tertiary care. Herein, 10% of patients referred to secondary care for NAFLD exhibited advanced liver disease, whilst 64% had no significant liver scarring. These findings underline the urgent need to define patient referral pathways for suspected liver disease.
Highlights
non-alcoholic fatty liver disease (NAFLD) is the most common liver disease with an estimated prevalence of 24%.1 NAFLD constitutes a progressive disease spectrum ranging from non-inflammatory steatosis, hepatitis (NASH), to liver cirrhosis.[2]More recently the term metabolically associated fatty liver disease has been suggested to provide positive criteria in the definition of the disease spectrum and to overcome limitations related to the role of social, non-abusive alcohol use.[3]
Non-invasive fibrosis scores By the use of non-commercial and accessible scoring surrogates, including FIB-4 index, NAFLD fibrosis score, and aspartate-aminotransferase-toplatelet ratio index (APRI) score, the cohort was grouped into patients with no significant fibrosis, indeterminate stage, and advanced fibrosis (Table 1)
NAFLD affects 24% of the European population, and its wide disease spectrum ranges from benign hepatic steatosis to progressive NASH, which is associated with a high risk for the development of cirrhosis and its sequelae, including hepatic decompensation and hepatocellular carcinoma.[25]
Summary
NAFLD constitutes a progressive disease spectrum ranging from non-inflammatory steatosis (non-alcoholic fatty liver), hepatitis (NASH), to liver cirrhosis.[2]. More recently the term metabolically associated fatty liver disease has been suggested to provide positive criteria in the definition of the disease spectrum and to overcome limitations related to the role of social, non-abusive alcohol use.[3] At the individual level, patients are burdened with impaired quality of life[4] and the risk to develop end-stage liver disease and its sequelae, including hepatic decompensation and hepatocellular carcinoma. The aim of the Fatty Liver Assessment in Germany (FLAG) study was to assess disease burden and provide data on the standard of care from secondary care. Conclusions: This is the first report on NAFLD from a secondary-care real-world cohort in Germany.
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