This is an observational study in which data from people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who have already started or will start treatment for CKD or T2D are collected and studied. In observational studies, observations are made without specified advice or interventions.
The main purpose of the study is to learn how patients with CKD and T2D are treated and how frequent clinical events like heart attacks, stroke, heart failure, atrial fibrillation, and kidney failure are occurring in these patients. This study will provide information on how the treatment of patients with CKD and T2D can be improved, and which patients and patient subgroups are at particular risk of developing specific clinical events. The findings of this study can provide important information to improve clinical guidelines and clinical care of patients with CKD and T2D.
To do this, the researchers will collect data on:
• Patient characteristics (e.g., age sex) of the participants
• Clinical characteristics (e.g., history of CKD and T2D, heart and liver health, other health problems) of the participants
• Clinical events (e.g., acute myocardial infarction, stroke, new-onset heart failure, new-onset atrial fibrillation, kidney failure) of the participants
The participants will receive their treatment as prescribed by their doctors during routine practice according to the approved product information.
This study is part of a multi-database study in which a common protocol is executed in several data sources (UK, US, China, Denmark, Spain, Japan). Results from each data source will be analysed independently, patient level data will not be combined.
The primary objective in this study is to describe incidence of cardiovascular events and kidney failure in patients with chronic kidney disease and type 2 diabetes mellitus in separate cohorts of patients initiating SGLT2i (sodium-glucose cotransporter 2 inhibitors), GLP-1 RA (glucagon-like peptide-1 receptor agonists), sMRA (steroidal mineralocorticoid receptor antagonists), or ACEi (angiotensin-converting enzyme inhibitors)/ARB (angiotensin receptor blockers).
The secondary objectives in this study are to accomplish the following in the study cohorts of patients with chronic kidney disease and type 2 diabetes mellitus:
• Describe healthcare resource utilisation
• Describe the absolute levels and relative change over time of measures of kidney function
Acute coronary syndrome; stroke; new-onset congestive heart failure; new-onset atrial fibrillation; kidney failure; inpatient hospital admissions, emergency department visits, specialist visits, GP visits; eGFR; UACR; serum potassium
Nikolaus Oberprieler - Chief Investigator - Bayer AS
Nikolaus Oberprieler - Corresponding Applicant - Bayer AS
alexander hartenstein - Collaborator - Bayer AG
David Vizcaya - Collaborator - Bayer AG
Eren Elci - Collaborator - Bayer AG
Yik Ming Fung - Collaborator - Bayer AG
Sohul Shuvo - Collaborator - Bayer AG
HES Accident and Emergency;HES Admitted Patient Care;HES Outpatient;ONS Death Registration Data;Practice Level Index of Multiple Deprivation