Treatment with bardoxolone methyl resulted in significant weight loss and showed no evidence of causing muscle wasting in patients with type 2 diabetes (T2D) and stage IV chronic kidney disease (CKD), according to findings published in the Journal of Diabetes and Its Complications.
A multinational phase 3 trial, the Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes study showed that treatment with this agent increased the estimated glomerular filtration rate and led to concurrent reductions in body weight. In this study, researchers conducted post-hoc analyses to further characterize reductions in body weight with bardoxolone methyl.
A total of 2185 patients with T2D and stage IV CDK were randomly assigned to receive either a once-daily oral dose of bardoxolone methyl (20 mg) or placebo treatment. As previously reported, patients receiving bardoxolone methyl experienced a significant reduction in body weight vs those in the placebo group (-5.7 kg; 95% CI, -6.0 to -5.3; P <0.001). The magnitude of weight loss was proportional to a patient’s baseline body mass index, and weight reduction was more pronounced in patients with a higher baseline body mass index. Patients treated with bardoxolone methyl also experienced significant reductions in waist circumference and improved glycemic control.
“While the effects on body weight and related parameters with bardoxolone methyl are generally considered beneficial in an obese population with [T2D] and CKD, weight loss may be an undesirable effect in some patients,” the researchers point out, adding that “subgroup analyses suggest that there was very limited loss of body weight in the small fraction of patients who were not overweight or obese.”
Chertow GM, Appel GB, Block GA, et al. Effects of bardoxolone methyl on body weight, waist circumference and glycemic control in obese patients with type 2 diabetes mellitus and stage 4 chronic kidney disease [published online September 13, 2018]. J Diabetes Complications. doi:10.1016/j.jdiacomp.2018.09.005