Clinical characteristics of patients with non-alcoholic fatty liver disease (NAFLD) in Germany – First data from the German NAFLD-Registry

Abstract

Background Non-alcoholic fatty liver disease (NAFLD) affects more than 18 million individuals in Germany. Real-world data help to better characterize the natural history of disease and standard of care. Methods The German NAFLD-Registry is a prospective non-interventional study initiated by the German Liver Foundation and aims to describe clinical characteristics and observe outcomes in patients with NAFLD recruited in secondary and tertiary care. Results From this ongoing study, baseline data of the first 501 patients (mean age 54 years, 48% women) were analysed. 13 % of the study population had a high risk for advanced fibrosis (FIB-4 ≥2.67), approximately one-third had a liver stiffness value ≥9.6kPa measured by transient elastography, and the clinical diagnosis of liver cirrhosis was present in 10%. Typical comorbidities were more prevalent in high risk as compared to low risk patients (FIB-4 <1.3) including arterial hypertension (85 vs. 42%), hypercholesterolemia (39 vs. 16%), and type 2 diabetes mellitus (T2DM) (69 vs. 26%). Patients with T2DM (192/501) had a higher NAFLD disease burden as shown by liver stiffness values ≥9.6 kPa (51%) and clinical diagnosis of cirrhosis (20%). Statins were used in 22% of the main population, while in diabetic patients, metformin, GLP-1 agonists, and SGLT2 inhibitors were used in 65, 17, and 17%, respectively. Uptake of life-style interventions such as physical exercise or nutritional counselling was generally low. Conclusion First data of the German NAFLD registry show that approximately every 10th patient has advanced NAFLD, highlights T2DM patients as a high-risk group and gives insights in the use of comedication and life-style interventions in secondary and tertiary care.

Relevance of GLP-1 receptor agonists or SGLT-2 inhibitors on the recruitment for clinical studies in patients with NAFLD

“…The prevalence of GLP-1 RA and SGLT2i therapies in the tertiary cohort seems to be comparable to the treatment rates of 17% for both drug classes that have been reported from other German secondary and tertiary care centers [24].…”

“…As expected, patients at our center suffered from concomitant cardiovascular diseases more frequently and were treated more intensely for their diabetes mellitus compared to individuals from a population-based cohort (GLP-1 RA 15.5% vs. 5.7%; SGLT2i 21.6% vs. 8.5%). The prevalence of GLP-1 RA and SGLT2i therapies in the tertiary cohort seems to be comparable to the treatment rates of 17% for both drug classes that have been reported from other German secondary and tertiary care centers [24].…”

“…GLP-1 RA and SGLT2i will therefore be the ‘background’ therapy for many patients with NASH, regardless of the status of their liver disease [13]. This trend can be already observed in German registry data, as the rate of GLP-1 RA prescriptions increased from 4% of diabetic NAFLD patients recruited between May 2017 and October 2019 [40] to 17% recruited between December 2020 and October 2022 [24]. A similar increase from about 4 to 17% was seen between 2017 and 2021 in our data.…”

“…Screening failure rates due to inappropriate biopsy results are often reported in study summaries, because they occur after informed consent during the screening process [17,22,23], while exclusion of patients due to prohibited concomitant medications is frequently not reported, because these study candidates can be excluded during the pre-screening process prior to obtaining informed study consent. German registry data indicate that 17% of NAFLD patients with type 2 diabetes mellitus receive GLP-1 RA or SGLT1i at secondary or tertiary referral centers [24]. However, these data are not linked to the fibrosis staging which is relevant for the recruitment of clinical studies.…”

Interleukin-13 (IL-13)—A Pleiotropic Cytokine Involved in Wound Healing and Fibrosis

“…Overall, the worldwide prevalence of steatotic liver disease is estimated at about 30% [ 10 ]. But currently, there is no approved pharmacotherapy for metabolic-dysfunction-associated steatohepatitis (MASH), the most common liver disease in the Western world and developing countries [ 11 , 12 ]. Patients with MASLD can develop metabolic-disease-associated steatohepatitis (MASH) and progression to MASH-fibrosis and -cirrhosis.…”