Physicians’ choice of which medications to initiate in patients with type 2 diabetes (T2D) and chronic kidney disease (CKD), in which sequence and in which combinations, is likely heterogeneous. Furthermore, recent changes in the treatment landscape have resulted in the emergence of new treatment options. In addition, this treatment heterogeneity constantly changes as new treatment alternatives are introduced. The present study aims to provide understanding on the use of antidiabetic drugs and steroidal mineralocorticoid receptor antagonists in persons with T2D and CKD. Moreover, we aim to provide a description of the population initiating those drugs in terms of clinical and demographic features. To do so, this study will use information from anonymized electronic health records collected between 2012 and 2020 and analyze it longitudinally to evaluate changes in treatments occurring in each of the cohorts of patients with CKD and T2D initiating one of the following drugs: SGLT2 inhibitors, GLP1-RA, Sulfonylurea, DPP4 inhibitors, insulin, metformin or steroidal MRAs. In addition, information on other concomitant conditions and other medications being prescribed by the time of initiating one of the drugs under study will be collected. These insights will help a more targeted and efficient management of CKD and T2D by providing a better understanding of treatment patterns in different populations of CKD and T2D, given the recent advances in therapeutic options in this area.
The present study aims to clarify how patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are treated with novel antidiabetics and sMRA describing visually and analytically longitudinal treatment patterns and pathways including treatment discontinuation, treatment switches and baseline patients’ characterization. Despite a focus on sodium-glucose transport protein 2 (SGLT2) and glucagon-like peptide 1 receptor agonists (GLP1-RA) , and to address this research objective in a contextualized manner providing a full-picture, different major antidiabetics used to treat T2D patients will be considered as cohort entry events as well.
The objectives of this study will be addressed using an observational retrospective cohort study on routinely-collected health care data mapped to OMOP CDM. The observation period will range from January 2012 to December 2020.
Seven separate and non-mutually exclusive patient cohorts of initiators of SGLT2 inhibitors, GLP1-RA, Sulfonylurea, DPP4 inhibitors, insulin, metformin or steroidal MRAs with previous CKD and T2D diagnoses in the medical history will be generated. The start of follow-up for each participant will be determined by the date of the first use of the medication of interest for each cohort (index event). End of follow-up will be determined by death, loss of follow-up, or end of study period. Furthermore, the main results will be presented stratified according to predefined age groups, gender, and pre-/post-COVID19 pandemic era (cutoff March, 1st 2020), to identify potential differences in treatment patterns between strata. This study will be conducted using observational healthcare data sources converted to the OMOP common data model, including CPRD and Optum EMR, allowing reproducibility and replicability of the study.
initiation of SGLT2 inhibitors; initiation of GLP1-RA; initiation of Sulfonylurea; initiation of DPP4 inhibitors; initiation of insulin; initiation of metformin; discontinuation of SGLT2 inhibitors; discontinuation of GLP1-RA; discontinuation of Sulfonylurea; discontinuation of DPP4 inhibitors; discontinuation of insulin; discontinuation of metformin; Type 2 diabetes; chronic kidney disease; renal function; albuminuria; death (censoring purposes)
David Vizcaya - Chief Investigator - Bayer AG
David Vizcaya - Corresponding Applicant - Bayer AG
Alain GAY - Collaborator - Bayer AG
Nikolaus Oberprieler - Collaborator - Bayer AS
Ronald Herrera - Collaborator - Bayer AG