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External Control Augmentation Increases Estimates Precision for Finerenone plus Sodium-Glucose Cotransporter-2
Sascha van Boemmel-Wegmann1, Chris Bauer2, Alexandra Zerck2
1Real World Evidence Center of Excellence, Global Medical & Evidence, Bayer AG, Berlin, Germany.
Kidney International Reports
|April 20, 2026
Summary
This study used electronic health records to create an external control arm, enhancing precision for finerenone treatment effects in patients with chronic kidney disease and type 2 diabetes. The augmented data confirmed finerenone
Area of Science:
- Cardiology
- Nephrology
- Pharmacology
Background:
- The FIDELITY analysis demonstrated finerenone's complementary benefit with SGLT-2 inhibitors in type 2 diabetes and CKD patients.
- Estimating finerenone's precise treatment effects was limited by comparator group representation in clinical trials.
Purpose of the Study:
- To augment the FIDELITY trial's comparator group using US electronic health record data for an external control arm (ECA).
- To enhance the statistical precision of finerenone's treatment effect estimates for cardiovascular and kidney outcomes.
Main Methods:
- Identified eligible patients from EHR data matching FIDELITY inclusion criteria.
- Matched 877 ECA patients 1:1 to FIDELITY SGLT-2i users using linear programming based on demographics and clinical factors.
- Calculated finerenone's treatment effects on composite CV/kidney endpoints, HHF, and mortality using augmented data.
Main Results:
- Matched ECA and FIDELITY SGLT-2i users showed minimal baseline differences (median ASMD 0.000).
- ECA augmentation improved estimate precision, yielding narrower confidence intervals compared to original FIDELITY data.
- Observed a significant benefit for finerenone + SGLT-2i subgroup versus augmented SGLT-2i controls for CV endpoint and HHF.
Conclusions:
- An external control arm effectively augments underrepresented populations in cardiorenal trials.
- ECA enhances statistical precision of treatment effect estimates when homogeneity with internal controls is sufficient.
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