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 in routine clinical practice.
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 not receiving optimal treatment. 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
• Treatments for T2D and CKD
• Other medications used
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, the Netherlands, Japan). Results from each data source will be analysed independently, patient level data will not be combined.
The overall aim of this study is to describe patient profiles and treatment patterns in medication initiator cohorts of patients with CKD and T2D.
The primary objective is to describe baseline patient characteristics, comorbidities, and comedications in adult patients with chronic kidney disease and type 2 diabetes mellitus who initiate a sodium-glucose cotransporter 2 inhibitor (SGLT2i), a glucagon-like peptide-1 receptor agonist (GLP 1-RA), steroidal mineral corticoid receptor antagonists (sMRA), or finerenone, in each of 2 time periods corresponding to finerenone pre-launch and post-launch dates.
The secondary objective(s) are
• To describe changes over time in treatments in the initiator cohorts including treatment discontinuation, treatment switches, add-on treatments, and titration (finerenone only) in each of 2 time periods corresponding to finerenone pre-launch and post-launch dates.
• To describe temporal changes in the baseline characteristics of the medication-specific cohorts before and after finerenone launch
This study will describe outcomes such as medication discontinuation and persistence. Changes in treatment, such as medication switch or added medications, will be describe.
To accurately classify length of treatment during follow-up, ONS Death Registration data is required.
Additional data sets such as HES Accident and Emergency, HES Admitted Patient Care, and HES Outpatient will be used to ensure correct classification of patients at the index date. This is especially relevant for the classification of CKD where information from all the above data sets is relevant.
Number who discontinued the index medication;
Number who started another study medication;
Number who added another study medication to the index therapy;
Number who uptitrate finerenone within 6 months;
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