Use of GLP-1 receptor agonists and subsequent risk of Acute Liver Injury (ALI) – A cohort study in the OMOP CDM (GLP1-ALI)

This study aims to analyse the risk of acute liver injury in second-line users of GLP-1 receptor agonists who have Type 2 diabetes mellitus (T2DM) and compare it to users of other second-line medications for T2DM.

Population: Adults above 18, who have been diagnosed with T2DM and who have 30 days of prior Metformin use as well as 365 days of observation period prior to index date. Those with prior history of T1DM will be excluded, as well as those with acute liver injury within one year prior to the index date and those with >30 days of insulin exposure prior to the index date. As we would like to study the possibility of GLP-1 receptor agonists worsening existing chronic liver conditions, we include all those with chronic liver diseases.

Comparators: Within the target cohort, new second-line initiators of GLP-1 receptor agonists will be compared to new second-line initiators of other medications in the SGLT2 and DPP4 groups.

Outcomes: The primary outcome to analyse is acute liver injury as defined by diagnostic code within the OHDSI Phenotype Library. Secondary outcomes include acute liver injury defined by laboratory tests, and cholelithiasis, cholecystitis, and/or chronic liver conditions as defined within the OHDSI Phenotype Library.