Health characteristics and treatment use in people with type 2 diabetes and kidney disease starting GLP-1 receptor agonist medication across countries

Declarations. Conflict of Interest: Alfredo E. Farjat, Fangfang Liu, Suguru Okami, Satoshi Yamashita, and Nikolaus G. Oberprieler are employees of Bayer, which funded this study. Alain Gay was an employee of Bayer when this research was conducted and is now an employee of Clario, Philadelphia, PA, USA. David Vizcaya was an employee of Bayer when this research was conducted and is now an employee of Alexion Pharma S.L., Barcelona, Spain. Catherine B. Johannes, Ryan Ziemiecki, Anam M. Khan, and J. Bradley Layton are employees of RTI Health Solutions, which received research funding for this study from Bayer. Manel Pladevall-Vila and Daniel Mines were employees of RTI Health Solutions at the time of the study. Brenda N. Baak, Jetty A. Overbeek, Fernie J.A. Penning-van Beest, and Ron M.C. Herings are employees of the PHARMO Institute for Drug Outcomes Research. This independent research institute performs financially supported studies for government and related healthcare authorities and several pharmaceutical companies. Craig I. Coleman has received grant funding and consulting fees from Bayer AG and AstraZeneca Pharmaceuticals. Csaba P. Kovesdy received consulting fees from Abbott, Akebia, Astra Zeneca, Bayer, Boehringer Ingelheim, Cara Therapeutics, CSL Behring, CSL Vifor, GSK, Pharmacosmos, ProKidney, Renibus and Takeda. Yuichiro Yano reports consultancy for Bayer. Naoki Kashihara reports research grants from Daiichi Sankyo, AstraZeneca, and Bayer. Natalie Ebert receives honoraria from Bayer AG. Reimar W. Thomsen has given presentations and lectures on medical research (both with and without financial compensation) for pharmaceutical companies, including AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Novo Nordisk, and Sanofi. Reimar W. Thomsen, Ina Trolle Andersen, Christian Fynbo Christiansen, and Frederik Pagh Bredahl Kristensen are employees of Aarhus University, which receives institutional research funding from public and private entities, including regulators, pharmaceutical companies, and contract research organizations. This includes the present study. Aníbal García-Sempere, Clara Rodríguez Bernal, Celia Robles Cabaniñas, and Isabel Hurtado are employed by FISABIO, a research body in Spain affiliated with the Health Department of the Valencia Government, which receives public and private funding to conduct biomedical research, including the present study. Ethical Approval: This study used de-identified data from electronic health records. Access to the data sources was through a collaboration model for DNHR, VID, PHARMO, J-CKD-DB-Ex and through a license for CDM. Ethics committee review was waived for DNHR and PHARMO. The study protocol was reviewed and approved by the Comité Ético de Investigación con Medicamentos del Hospital Clínico Universitario de Valencia for VID (2022/164). This study protocol was reviewed and approved by the ethics committee of the Shiga University of Medical Science for J-CKD-DB-Ex (R2022-143). CDM data are de‐identified and are compliant with the Health Insurance Portability and Accountability Act of 1996. This study was deemed to not constitute research involving human subjects according to 45 Code of Federal Regulations 46.102(f) and was deemed exempt from board oversight. The institutional review board of RTI International deemed the study exempt from full review. This study was performed in accordance with the Helsinki Declaration of 1964 and its later amendments. Patient consent for participation and patient consent for publication are not applicable, except for J-CKD-DB-Ex, where informed consent was obtained through an opt-out method on the website of participating university hospitals.