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
- Chertow, Glenn, Stanford University School of Medicine, Stanford, California, United States
- Jongs, Niels, Universiteit Groningen Faculteit Medische Wetenschappen, Groningen, Groningen, Netherlands
- Correa-Rotter, Ricardo, National Medical Science and Nutrition Institute Salvador Zubiran, Mexico City, Mexico, Mexico
- Rossing, Peter, Steno Diabetes Center Copenhagen, Herlev, Denmark
- Toto, Robert D., UT Southwestern Medical Center, Department of Internal Medicine, Dallas, Texas, United States
- Wheeler, David C., University College London Faculty of Medical Sciences, London, London, United Kingdom
- McMurray, John, University of Glasgow, Glasgow, Glasgow, United Kingdom
- Langkilde, Anna Maria, AstraZeneca, BioPharmaceuticals R&D, Gothenburg, Sweden
- L Heerspink, Hiddo Jan, Universiteit Groningen Faculteit Medische Wetenschappen, Groningen, Groningen, Netherlands
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