Bardoxolone increased risk for CV events in patients with diabetes, CKD

Bardoxolone methyl did not reduce the risk for end-stage renal disease or death from cardiovascular causes in patients with type 2 diabetes and stage 4 chronic kidney disease, according to data.

However, due to the increased rate of CV events with bardoxolone methyl, the BEACON trial was halted, according to Dick de Zeeuw, MD, PhD, of the University of Groningen in the Netherlands, and colleagues.

The researchers randomly assigned 2,185 patients with type 2 diabetes and stage 4 CKD to 20 mg daily of bardoxolone methyl — an oral synthetic triterpenoid — or placebo.

Follow-up data indicated that 69 of 1,088 patients (6%) who were randomly assigned to bardoxolone methyl and 69 of 1,097 (6%) patients who were randomly assigned to placebo displayed the primary composite outcome (HR=0.98; 95% CI, 0.7-1.37).

Forty-three patients developed end-stage renal disease (ESRD) in the bardoxolone methyl group, and 27 patients died of CV causes, researchers wrote. Moreover, 51 patients in the placebo group developed ESRD and 19 patients died of CV causes.

The researchers also reported that 96 patients in the bardoxolone methyl group were hospitalized for heart failure or died of heart failure vs. 55 patients in the placebo group (HR=1.83; 95% CI, 1.32-2.55).

“Although patients treated with bardoxolone methyl had a significant increase in the estimated GFR, as compared with those who received placebo, there was a significantly higher incidence of heart failure and of the composite outcome of nonfatal myocardial infarction, nonfatal stroke, hospitalization for [heart failure], or death from cardiovascular causes in the bardoxolone methyl group,” researchers wrote. “There were numerically more deaths from any cause among patients treated with bardoxolone methyl than among those in the placebo group.”

Disclosure: de Zeeuw reports financial relationships with AbbVie, Astellas, Chemocentryx, Johnson & Johnson and Reata.