NEW YORK & ISTANBUL–(BUSINESS WIRE)–#Dataanalytics–A groundbreaking study led by researchers from Columbia Data Analytics, Bogazici University and the City University of New York (CUNY) College of Technology, has demonstrated that semaglutide, a GLP-1 receptor agonist, significantly reduces the risk of major kidney disease events among patients with type 2 diabetes (T2D) and chronic kidney disease (CKD) in real-world clinical practice.
Key findings:
- 26% Reduction in Major Kidney Events: Compared with standard care, semaglutide treatment was associated with a 26% reduction in the risk of major kidney disease events, including kidney failure and substantial loss of kidney function. This effect is consistent with, and slightly exceeds, the 24% risk reduction observed in the landmark FLOW clinical trial.
- Robust Real-World Evidence: Creating 896,257 external control arm semaglutide users and a comparator group from the Kythera Labs database (2019–2024), the study provides the largest real-world evaluation of semaglutide’s renoprotective effects to date.
- Broad Patient Representation: The real-world cohort included a more diverse, representative patient population than typical clinical trials, enhancing the generalizability of the findings.
-
Consistent Results Across Sensitivity Analyses: The study’s conclusions remained robust across multiple sensitivity analyses, further supporting the reliability of the results.
The researchers constructed an external control arm using real-world data and applied rigorous statistical methods, including propensity score matching and Cox regression, to ensure comparability with the FLOW trial population. The primary outcome was a composite of kidney failure onset and a sustained 50% reduction in estimated glomerular filtration rate.
“These results provide compelling real-world evidence for the use of semaglutide in reducing the risk of kidney failure and progression in patients with type 2 diabetes and CKD,” said lead author Dr. Onur Baser. “The findings support broader adoption of semaglutide as a renoprotective therapy and may inform clinical guidelines, payer coverage decisions, and health policy.”
Although reliance on diagnosis codes and the inability to confirm medication adherence are limitations typical of observational research, the large sample size, advanced statistical adjustments, and consistency with clinical trial data strengthen the findings’ validity.
About the Study
- Authors: Onur Baser, PhD (Bogazici University, City University of New York [CUNY] College of Technology) and Yuanqing Lu, MS (Columbia Data Analytics)
- Data Source: Kythera Labs, 2019–2024
- Presented at: ISPOR 2025, Montréal, Québec, Canada
- Funding: No external funding
- Conflicts of Interest: None declared
Citation: Baser O, Lu Y. External control arm with real world data to assess the effect of semaglutide on chronic kidney disease risk among patients with type 2 diabetes. Expert Opinion on Pharmacotherapy. Accepted June 6, 2025. https://doi.org/10.1080/14656566.2025.2518329
Contacts
Elizabeth Vivier
lizv@cdanyc.com
