CONFIDENCE ASIA: EFFECT OF SIMULTANEOUS INITIATION OF FINERENONE AND EMPAGLIFLOZIN ON URINARY ALBUMIN-TO-CREATININE RATIO IN ASIAN PARTICIPANTS FROM THE CONFIDENCE TRIAL

 

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https://storage.unitedwebnetwork.com/files/1099/b499203dcc9f310e02c5737de98c5e97.pdf
CONFIDENCE ASIA: EFFECT OF SIMULTANEOUS INITIATION OF FINERENONE AND EMPAGLIFLOZIN ON URINARY ALBUMIN-TO-CREATININE RATIO IN ASIAN PARTICIPANTS FROM THE CONFIDENCE TRIAL

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Rajiv
Agarwal
Byung-Wan Lee BWANLEE@yuhs.ac Yonsei University College of Medicine Division of Endocrinology and Metabolism, Department of Internal Medicine Seoul -
Rajiv Agarwal ragarwal@iu.edu Richard L. Roudebush VA Medical Center and Indiana University School of Medicine Division of Nephrology Indianapolis, IN United States *
Jennifer B. Green Jennifer.Green@duke.edu Duke University School of Medicine Division of Endocrinology, Department of Medicine and Duke Clinical Research Institute Durham, NC United States -
Hiddo J. L. Heerspink h.j.lambers.heerspink@umcg.nl University of Groningen Department of Clinical Pharmacy and Pharmacology Groningen Netherlands -
Johannes F. E. Mann prof.j.mann@googlemail.com KfH Kidney Centre Munich and Friedrich Alexander University Department of Nephrology & Hypertension Munchen Germany -
Janet B. McGill jmcgill@wustl.edu Washington University in St. Louis Division of Endocrinology, Metabolism & Lipid Research St. Louis, MO United States -
Amy Mottl amy_mottl@med.unc.edu University of North Carolina School of Medicine University of North Carolina Kidney Center and Duke Clinical Research Institute Chapel Hill, NC United States -
Takeshi Osonoi t-osonoi@kensei-kai.com Naka Kinen Clinic Department of Internal Medicine Ibaraki Japan -
Atanu Pal dratanupal@gmail.com Institute of Post Graduate Medical Education and Research and SSKM Department of Nephrology Kolkata India -
Peter Rossing peter.rossing@regionh.dk Steno Diabetes Center Copenhagen and University of Copenhagen Department of Clinical Medicine Copenhagen Denmark -
Julio Rosenstock juliorosenstock@dallasdiabetes.com Velocity Clinical Research at Medical City Dallas Diabetes Research Consulting Dallas, TX United States -
Muthiah Vaduganathan mvaduganathan@bwh.harvard.edu Brigham and Women's Hospital and Harvard Medical School Division of Cardiovascular Medicine Boston, MA United States -
Charlie Scott charlie.scott@bayer.com Bayer Healthcare Inc Clinical Statistics and Analytics Whippany, NJ United States -
Satoshi Yamashita satoshi.yamashita@bayer.com Bayer Yakuhin Ltd Medical Affairs & Pharmacovigilance Osaka Japan -
Masaomi Nangaku mnangaku@m.u-tokyo.ac.jp The University of Tokyo Graduate School of Medicine Division of Nephrology and Endocrinology Tokyo Japan -

Treatment benefits of simultaneous initiation and combination therapy with the nonsteroidal mineralocorticoid receptor antagonist finerenone and a sodium–glucose cotransporter 2 inhibitor (SGLT2i) in reducing urinary albumin-to-creatinine ratio (UACR) have been reported in the CONFIDENCE trial. We evaluated the benefits and safety profile of combination therapy with finerenone and an SGLT2i in participants enrolled in Asia.

The CONFIDENCE trial enrolled adults with chronic kidney disease and type 2 diabetes with a UACR of ≥100 to ≤5000 mg/g and on a renin–angiotensin system inhibitor. Participants were randomized 1:1:1 to once-daily finerenone (10 or 20 mg) plus empagliflozin (10 mg), finerenone (10 or 20 mg) plus placebo, or empagliflozin (10 mg) plus placebo. In a subgroup analysis, treatment effects on the primary endpoint of relative change in UACR from baseline at day 180 were assessed for Asian participants.

In CONFIDENCE, among 360 participants (45%) enrolled from Asia, change in UACR from baseline (95% CI) at day 180 with combination therapy was −30% (−44%, −11%) vs finerenone alone and −34% (−47%, −16%) vs empagliflozin alone; Table). The proportion of Asian participants with any treatment-emergent hyperkalemia adverse events (AEs) was 10.7% for those receiving combination therapy, 13.8% for finerenone alone, and 4.8% for empagliflozin alone. No treatment-emergent hyperkalemia AEs led to hospitalization, permanent discontinuation of study drug, or death. These findings are consistent with those for the overall study population.

Simultaneous initiation of finerenone and an SGLT2i was effective and well-tolerated among the nearly half of participants in CONFIDENCE who were enrolled from Asia.

This abstract was also submitted to the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD).

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