Efficacy and Safety of Dapagliflozin in Patients With CKD Across Major Geographic Regions

Priya Vart, Ricardo Correa-Rotter, Fan Fan Hou, Niels Jongs, Glenn M. Chertow, Anna Maria Langkilde, John J.V. McMurray, Peter Rossing, C. David Sjöström, Bergur V. Stefansson, Robert D. Toto, Walter Douthat, Elizabeth Escudero, Rey Isidto, Dinesh Khullar, Harpreet S. Bajaj, David C. Wheeler, Hiddo J.L. Heerspink

Research output: Contribution to journalArticlepeer-review

1 Scopus citations

Abstract

Introduction: This study aimed to examine the efficacy and safety of dapagliflozin in the Dapagliflozin and Prevention of Adverse Outcomes in Chronic Kidney Disease (DAPA-CKD) trial (NCT03036150) by geographic region. Methods: Adults with chronic kidney disease (CKD) with or without type 2 diabetes, with estimated glomerular filtration rate (eGFR) 25 to 75 ml/min per 1.73 m2 and urinary albumin-to-creatinine ratio (UACR) 200 to 5000 mg/g were randomized to dapagliflozin (10 mg once daily) or placebo. The primary end point was a composite of a sustained decline in eGFR of ≥50%, end-stage kidney disease or death from kidney or cardiovascular causes. We categorized recruiting countries into 4 broad global regions: Asia, Europe, Latin America, and North America. Of 4304 randomized patients, 1346 (31.3%) were from Asia, 1233 (28.6%) from Europe, 912 (21.2%) from Latin America, and 813 (18.9%) from North America. Results: The relative risk of the primary composite end point was lower in patients randomized to dapagliflozin (relative to placebo) in all regions, with hazard ratios (95% CI) of 0.70 (0.48–1.00), 0.60 (0.43–0.85), 0.61 (0.43–0.86), and 0.51 (0.34–0.76) among patients from Asia, Europe, Latin America, and North America, respectively. There was no effect modification by region (interaction P = 0.77). Occurrence of serious adverse events (SAEs) was lower among patients randomized to dapagliflozin versus placebo (21.9% vs. 26.8%, 34.1% vs. 38.6%, 29.8% vs. 31.5%, and 34.9% vs. 41.0% in Asia, Europe, Latin America, and North America, respectively). Conclusion: Dapagliflozin reduced kidney and cardiovascular events and prolonged survival in patients with CKD, with and without type 2 diabetes, with no apparent effect modification by geographic region.

Original languageEnglish (US)
JournalKidney International Reports
DOIs
StateAccepted/In press - 2022

Keywords

  • SGLT-2 inhibitor
  • dapagliflozin
  • efficacy
  • regions
  • safety

ASJC Scopus subject areas

  • Nephrology

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