Kidney Week

Abstract: SA-PO889

Efficacy and Safety of Dapagliflozin in Black vs. White Patients With CKD

Session Information

• CKD: Clinical Trials and Pharmacoepidemiology
  November 05, 2022 | Location: Exhibit Hall, Orange County Convention Center‚ West Building
  Abstract Time: 10:00 AM - 12:00 PM

Category: CKD (Non-Dialysis)

• 2202 CKD (Non-Dialysis): Clinical‚ Outcomes‚ and Trials

Authors

• Vart, Priya, Universiteit Groningen Faculteit Medische Wetenschappen, Groningen, Groningen, Netherlands

Priya Vart,

• Chertow, Glenn, Stanford University School of Medicine, Stanford, California, United States

Glenn Chertow,

• Jongs, Niels, Universiteit Groningen Faculteit Medische Wetenschappen, Groningen, Groningen, Netherlands

Niels Jongs,

• Correa-Rotter, Ricardo, National Medical Science and Nutrition Institute Salvador Zubiran, Mexico City, Mexico, Mexico

Ricardo Correa-Rotter,

• Rossing, Peter, Steno Diabetes Center Copenhagen, Herlev, Denmark

Peter Rossing,

• Toto, Robert D., UT Southwestern Medical Center, Department of Internal Medicine, Dallas, Texas, United States

Robert D. Toto,

• Wheeler, David C., University College London Faculty of Medical Sciences, London, London, United Kingdom

David C. Wheeler,

• McMurray, John, University of Glasgow, Glasgow, Glasgow, United Kingdom

John McMurray,

• Langkilde, Anna Maria, AstraZeneca, BioPharmaceuticals R&D, Gothenburg, Sweden

Anna Maria Langkilde,

• L Heerspink, Hiddo Jan, Universiteit Groningen Faculteit Medische Wetenschappen, Groningen, Groningen, Netherlands

Hiddo Jan L Heerspink,

Background

Previous reports suggest that Black and White patients may respond differently to certain treatments for chronic kidney disease (CKD). We investigated the efficacy and safety of dapagliflozin in Black and White patients in the DAPA-CKD trial.

Methods

Adults with CKD, with or without type 2 diabetes, with eGFR 25-75 mL/min/1.73m² and UACR 200-5000 mg/g were randomized to dapagliflozin (10mg/day) or placebo. The majority of Black patients (>96%) were randomized in North and South America, so this post-hoc analysis only included patients enrolled in the Americas. Patients self-identified as Black or White. The primary outcome was a composite of ≥50% sustained eGFR decline, end-stage kidney disease, or death from kidney or cardiovascular causes.

Results

Overall, 1271 (29.5%) were enrolled in the Americas. Of these, 185 (14.6%) were Black and 1086 (85.4%) White. Over 2.2-years’ median follow-up, 20 (10.8%) Black and 139 (12.8%) White patients developed the primary composite outcome (event rate, 5.3 and 6.2/100 patient years, respectively). Compared with placebo, dapagliflozin reduced the risk of the primary outcome in Black (HR: 0.35; 95%CI: 0.14-0.88) and White patients (HR: 0.64; 95%CI: 0.45-0.89; p-interaction=0.31). Consistent benefits were observed for other prespecified outcomes (Table). Occurrence of serious adverse events was similar with dapagliflozin vs placebo in Black (30.4% vs 39.8%) and White patients (34.9% vs 39.0%).

Conclusion

Black and White patients experienced similar clinical benefits with dapagliflozin including fewer kidney and cardiovascular events and prolonged survival, with a similar safety profile.

Funding

• Commercial Support – AstraZeneca