Dataset Information

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

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.

SUBMITTER: Vart P

PROVIDER: S-EPMC9039473 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Publications

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

Vart Priya P Correa-Rotter Ricardo R Hou Fan Fan FF Jongs Niels N Chertow Glenn M GM Langkilde Anna Maria AM McMurray John J V JJV Rossing Peter P Sjöström C David CD Stefansson Bergur V BV Toto Robert D RD Douthat Walter W Escudero Elizabeth E Isidto Rey R Khullar Dinesh D Bajaj Harpreet S HS Wheeler David C DC Heerspink Hiddo J L HJL

Kidney international reports 20220202 4

<h4>Introduction</h4>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.<h4>Methods</h4>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<sup>2</sup> and urinary albumin-to-creatinine ratio (UACR) 200 to 5000 mg/g were randomized to dapagliflozin ( ...[more]

PMID: 35497805

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Dataset Information

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

Introduction

Methods

Results

Conclusion

Publications

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

Similar Datasets

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