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.

Zusammenfassung

Hintergrund In Deutschland sind mehr als 18 Millionen Menschen von einer nichtalkoholischen Fettlebererkrankung (NAFLD) betroffen. Real-world-Daten können dazu beitragen, die natürlichen Krankheitsverläufe und den Behandlungsstandard besser zu beschreiben.

Methoden Das Deutsche NAFLD-Register ist eine prospektive nicht interventionelle Studie der Deutschen Leberstiftung zur Beschreibung klinischer Charakteristika und Krankheitsverläufe von NAFLD-Patienten in sekundären und tertiären Versorgungsstrukturen.

Ergebnisse Im Rahmen dieser laufenden Studie wurden die Baseline-Daten der ersten 501 Patienten (Durchschnittsalter 54 Jahre, 48 % Frauen) analysiert. 13 % der Studienpopulation hatten ein hohes Risiko für eine fortgeschrittene Fibrose (FIB-4 index ≥2,67), etwa ein Drittel hatte einen mittels transienter Elastografie gemessenen Lebersteifigkeitswert (LSW) ≥9,6 kPa, und bei 10 % lag die klinische Diagnose einer Leberzirrhose vor. Typische Begleiterkrankungen waren bei Patienten mit einem FIB-4 ≥2,67 häufiger anzutreffen als bei Patienten mit einem FIB-4 <1,3, darunter arterielle Hypertonie (85 vs. 42 %), Hypercholesterinämie (39 vs. 16 %) und Diabetes mellitus Typ 2 (T2DM) (69 vs. 26 %). Patienten mit T2DM (192/501) hatten eine höhere NAFLD-Krankheitslast, die sich in LSW ≥9,6k Pa (51%) und der klinischen Diagnose einer Zirrhose (20%) zeigte. Statine wurden bei 22 % der gesamten Studienpopulation eingesetzt, während bei den Diabetikern Metformin, GLP-1-Agonisten und SGLT2-Hemmer bei 65, 17 bzw. 17 % eingesetzt wurden. Eine Einflussnahme auf den Lebensstil durch körperliche Betätigung oder Ernährungsberatung war im Allgemeinen gering.

Schlussfolgerungen Die ersten Daten aus dem Deutschen NAFLD-Register zeigen, dass etwa jeder zehnte Patient eine fortgeschrittene Fibrose hat und T2DM-Patienten eine Hochrisikogruppe darstellen. Weiterhin geben sie Hinweise auf den Einsatz von Medikamenten und Lebensstilinterventionen in der Sekundär- und Tertiärversorgung.

Schlüsselwörter

Typ 2 Diabetes mellitus - Leberzirrhose - metabolisches Syndrom - Adipositas - NAFLD - NASH

Keywords

Type 2 diabetes - liver cirrhosis - metabolic syndrome - obesity - NAFLD - NASH

Publication History

Received: 02 November 2022

Accepted after revision: 23 November 2022

Article published online:
09 January 2023

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