Evidence map›Paper›PMID 42006210›Full record

ArticleKidney international reports2026

External Control Augmentation Increases Estimates Precision for Finerenone plus Sodium-Glucose Cotransporter-2 Inhibitors.

Sascha van Boemmel-Wegmann, Chris Bauer, Alexandra Zerck, Alexander Hartenstein, Johannes Schuchhardt, Rachel Knapp, Robert Edfors, Alfredo E Farjat, Michael Walsh

Abstract read
In one paragraph

Article in Kidney international reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Sascha van Boemmel-WegmannReal World Evidence Center of Excellence, Global Medical & Evidence, Bayer AG, Berlin, Germany.
Chris BauerMicroDiscovery GmbH, Berlin, Germany.
Alexandra ZerckMicroDiscovery GmbH, Berlin, Germany.
Alexander HartensteinReal World Evidence Center of Excellence, Global Medical & Evidence, Bayer AG, Berlin, Germany.
Johannes SchuchhardtMicroDiscovery GmbH, Berlin, Germany.
Rachel KnappReal World Evidence Center of Excellence, Global Medical & Evidence, Bayer AG, Berlin, Germany.
Robert EdforsReal World Evidence Center of Excellence, Global Medical & Evidence, Bayer AG, Berlin, Germany.
Alfredo E FarjatBayer BV, Clinical Statistics and Analytics, Hoofddorp, Netherlands.
Michael WalshDivision of Nephrology, Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: The FIDELITY pooled analysis of the FIDELIO-DKD and FIGARO-DKD trials showed a complementary benefit of finerenone and sodium-glucose cotransporter-2 inhibitors (SGLT-2is) in patients with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2D). This study used US electronic health record (EHR) data to create an external control arm (ECA) to augment the FIDELITY comparator group and improve the precision of finerenone's treatment effect estimates. Methods: We identified eligible patients from EHR data who met the adapted FIDELITY criteria. These ECA patients were matched (1:1) to the pool of SGLT-2i users within the FIDELITY population using a linear programming method based on baseline demographics and clinical characteristics. We then calculated the treatment effects of finerenone on cardiovascular (CV) and kidney composite end points, hospitalization for heart failure (HHF), and all-cause mortality, incorporating the augmented ECA data. Results: Eligible ECA patients ( Conclusion: Our findings demonstrate that an ECA can effectively augment underrepresented study populations in cardiorenal trials, enhancing the statistical precision of treatment effect estimates when there is sufficient homogeneity between the internal and external control groups.

Indexed as

chronic renal insufficiencydiabetes mellitus type 2electronic health recordsmineralocorticoid receptor antagonistssodium-glucose transporter 2 inhibitors

Identifiers

PMID42006210
PMCPMC13088957

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.