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https://hdl.handle.net/2440/116654
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Type: | Journal article |
Title: | Bardoxolone methyl in type 2 diabetes and stage 4 chronic kidney disease |
Author: | De Zeeuw, D. Akizawa, T. Audhya, P. Bakris, G. Chin, M. Christ-Schmidt, H. Goldsberry, A. Houser, M. Krauth, M. Lambers Heerspink, H. McMurray, J. Meyer, C. Parving, H. Remuzzi, G. Toto, R. Vaziri, N. Wanner, C. Wittes, J. Wrolstad, D. Chertow, G. et al. |
Citation: | New England Journal of Medicine, 2013; 369(26):2492-2503 |
Publisher: | Massachusetts Medical Society |
Issue Date: | 2013 |
ISSN: | 0028-4793 1533-4406 |
Statement of Responsibility: | Dick de Zeeuw, Tadao Akizawa, Paul Audhya, George L. Bakris, Melanie Chin ... Gary A. Wittert ... et al. |
Abstract: | Background: Although inhibitors of the renin–angiotensin–aldosterone system can slow the progression of diabetic kidney disease, the residual risk is high. Whether nuclear 1 factor (erythroid-derived 2)–related factor 2 activators further reduce this risk is unknown. Methods: We randomly assigned 2185 patients with type 2 diabetes mellitus and stage 4 chronic kidney disease (estimated glomerular filtration rate [GFR], 15 to <30 ml per minute per 1.73 m2 of body-surface area) to bardoxolone methyl, at a daily dose of 20 mg, or placebo. The primary composite outcome was end-stage renal disease (ESRD) or death from cardiovascular causes. Results: The sponsor and the steering committee terminated the trial on the recommendation of the independent data and safety monitoring committee; the median follow-up was 9 months. A total of 69 of 1088 patients (6%) randomly assigned to bardoxolone methyl and 69 of 1097 (6%) randomly assigned to placebo had a primary composite outcome (hazard ratio in the bardoxolone methyl group vs. the placebo group, 0.98; 95% confidence interval [CI], 0.70 to 1.37; P=0.92). In the bardoxolone methyl group, ESRD developed in 43 patients, and 27 patients died from cardiovascular causes; in the placebo group, ESRD developed in 51 patients, and 19 patients died from cardiovascular causes. A total of 96 patients in the bardoxolone methyl group were hospitalized for heart failure or died from heart failure, as compared with 55 in the placebo group (hazard ratio, 1.83; 95% CI, 1.32 to 2.55; P<0.001). Estimated GFR, blood pressure, and the urinary albumin-to-creatinine ratio increased significantly and body weight decreased significantly in the bardoxolone methyl group, as compared with the placebo group. Conclusions: Among patients with type 2 diabetes mellitus and stage 4 chronic kidney disease, bardoxolone methyl did not reduce the risk of ESRD or death from cardiovascular causes. A higher rate of cardiovascular events with bardoxolone methyl than with placebo prompted termination of the trial. (Funded by Reata Pharmaceuticals; BEACON ClinicalTrials.gov number, NCT01351675.) |
Keywords: | BEACON Trial Investigators Humans Diabetic Nephropathies Kidney Failure, Chronic Cardiovascular Diseases Diabetes Mellitus, Type 2 Weight Loss Oleanolic Acid Glomerular Filtration Rate Treatment Failure Double-Blind Method Aged Middle Aged Female Male NF-E2-Related Factor 2 Renal Insufficiency, Chronic Intention to Treat Analysis Kaplan-Meier Estimate |
Rights: | © 2013, Massachusetts Medical Society |
DOI: | 10.1056/NEJMoa1306033 |
Published version: | http://dx.doi.org/10.1056/nejmoa1306033 |
Appears in Collections: | Aurora harvest 8 Medicine publications |
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