Vart, P. et al. (2022) Efficacy and safety of dapagliflozin in patients with CKD across major geographic regions. Kidney International Reports, 7(4), pp. 699-707. (doi: 10.1016/j.ekir.2022.01.1060) (PMID:35497805) (PMCID:PMC9039473)
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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.
Item Type: | Articles |
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Keywords: | Dapagliflozin, efficacy, regions, SGLT-2 inhibitor, safety. |
Status: | Published |
Refereed: | Yes |
Glasgow Author(s) Enlighten ID: | McMurray, Professor John |
Authors: | Vart, P., Correa-Rotter, R., Hou, F. F., Jongs, N., Chertow, G. M., Langkilde, A. M., McMurray, J. J. V., Rossing, P., Sjöström, C. D., Stefansson, B. V., Toto, R. D., Douthat, W., Escudero, E., Isidto, R., Khullar, D., Bajaj, H. S., Wheeler, D. C., and Heerspink, H. J. L. |
College/School: | College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health |
Journal Name: | Kidney International Reports |
Publisher: | Elsevier |
ISSN: | 2468-0249 |
ISSN (Online): | 2468-0249 |
Published Online: | 02 February 2022 |
Copyright Holders: | Copyright © 2022 International Society of Nephrology |
First Published: | First published in Kidney International Reports 7(4): 699-707 |
Publisher Policy: | Reproduced under a Creative Commons License |
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