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

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

来源：Kidney International Reports, 2022, 7(4): 699-707.

DOI：10.1016/j.ekir.2022.01.1060

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

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 m(2) 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.

• 单位
  南方医科大学; 1