Why the study?
Does bardoxolone methyl reduce the risk of ESRD or death from cardiovascular causes in patients with type 2 diabetes mellitus and stage 4 chronic kidney disease?
Does bardoxolone methyl reduce the risk of ESRD or death from cardiovascular causes in patients with type 2 diabetes mellitus and stage 4 chronic kidney disease?
Bardoxolone methyl does not improve renal or cardiovascular outcomes in patients with type 2 diabetes and stage 4 CKD, and is associated with an increased risk of cardiovascular events.
Bardoxolone methyl should not be used in type 2 diabetes with stage 4 CKD; challenges prior signals of renal benefit.
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.).
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Zeeuw et al. (2013) studied this question.
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