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

Glenn M. Chertow, Gerald B. Appel, Geoffrey A. Block, Melanie P. Chin, Daniel W. Coyne, Angie Goldsberry, Kamyar Kalantar-Zadeh, Colin J. Meyer, Mark E. Molitch, Pablo E. Pergola, Philip Raskin, Arnold L. Silva, Bruce Spinowitz, Stuart M. Sprague, Peter Rossing

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Aims: Obesity is associated with progression of chronic kidney disease (CKD). Treatment with bardoxolone methyl in a multinational phase 3 trial, Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes (BEACON), resulted in increases in estimated glomerular filtration rate (eGFR) with concurrent reductions in body weight. We performed post-hoc analyses to further characterize reductions in body weight with bardoxolone methyl. Methods: Eligible patients with type 2 diabetes (T2DM) and CKD stage 4 (eGFR 15 to <30 mL/min/1.73 m2) were randomized 1:1 to receive once-daily oral dose of bardoxolone methyl (20 mg) or placebo. Results: BEACON enrolled 2185 patients. Patients randomized to bardoxolone methyl experienced significant reductions in body weight from baseline relative to patients randomized to placebo (−5.7 kg; 95% CI: −6.0 to −5.3 kg; p < 0.001). In patients randomized to bardoxolone methyl, rate and magnitude of body weight loss were proportional to baseline BMI. Bardoxolone methyl resulted in significant reductions in waist circumference and improved glycemic control. Conclusions: Bardoxolone methyl resulted in significant weight loss in a generally obese patient population with T2DM and stage 4 CKD, with the magnitude and rate dependent on baseline BMI.

Original languageEnglish (US)
JournalJournal of Diabetes and its Complications
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Waist Circumference
Chronic Renal Insufficiency
Type 2 Diabetes Mellitus
Body Weight
Glomerular Filtration Rate
Weight Loss
Placebos
methyl 2-cyano-3,12-dioxoolean-1,9-dien-28-oate
Obesity
Population

Keywords

  • Bardoxolone methyl
  • Chronic kidney disease
  • HbA
  • Metabolic effects
  • Obesity
  • Randomized clinical trial

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Endocrinology

Cite this

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. / Chertow, Glenn M.; Appel, Gerald B.; Block, Geoffrey A.; Chin, Melanie P.; Coyne, Daniel W.; Goldsberry, Angie; Kalantar-Zadeh, Kamyar; Meyer, Colin J.; Molitch, Mark E.; Pergola, Pablo E.; Raskin, Philip; Silva, Arnold L.; Spinowitz, Bruce; Sprague, Stuart M.; Rossing, Peter.

In: Journal of Diabetes and its Complications, 01.01.2018.

Research output: Contribution to journalArticle

Chertow, GM, Appel, GB, Block, GA, Chin, MP, Coyne, DW, Goldsberry, A, Kalantar-Zadeh, K, Meyer, CJ, Molitch, ME, Pergola, PE, Raskin, P, Silva, AL, Spinowitz, B, Sprague, SM & Rossing, P 2018, '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', Journal of Diabetes and its Complications. https://doi.org/10.1016/j.jdiacomp.2018.09.005
Chertow, Glenn M. ; Appel, Gerald B. ; Block, Geoffrey A. ; Chin, Melanie P. ; Coyne, Daniel W. ; Goldsberry, Angie ; Kalantar-Zadeh, Kamyar ; Meyer, Colin J. ; Molitch, Mark E. ; Pergola, Pablo E. ; Raskin, Philip ; Silva, Arnold L. ; Spinowitz, Bruce ; Sprague, Stuart M. ; Rossing, Peter. / 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. In: Journal of Diabetes and its Complications. 2018.
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abstract = "Aims: Obesity is associated with progression of chronic kidney disease (CKD). Treatment with bardoxolone methyl in a multinational phase 3 trial, Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes (BEACON), resulted in increases in estimated glomerular filtration rate (eGFR) with concurrent reductions in body weight. We performed post-hoc analyses to further characterize reductions in body weight with bardoxolone methyl. Methods: Eligible patients with type 2 diabetes (T2DM) and CKD stage 4 (eGFR 15 to <30 mL/min/1.73 m2) were randomized 1:1 to receive once-daily oral dose of bardoxolone methyl (20 mg) or placebo. Results: BEACON enrolled 2185 patients. Patients randomized to bardoxolone methyl experienced significant reductions in body weight from baseline relative to patients randomized to placebo (−5.7 kg; 95{\%} CI: −6.0 to −5.3 kg; p < 0.001). In patients randomized to bardoxolone methyl, rate and magnitude of body weight loss were proportional to baseline BMI. Bardoxolone methyl resulted in significant reductions in waist circumference and improved glycemic control. Conclusions: Bardoxolone methyl resulted in significant weight loss in a generally obese patient population with T2DM and stage 4 CKD, with the magnitude and rate dependent on baseline BMI.",
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AU - Appel, Gerald B.

AU - Block, Geoffrey A.

AU - Chin, Melanie P.

AU - Coyne, Daniel W.

AU - Goldsberry, Angie

AU - Kalantar-Zadeh, Kamyar

AU - Meyer, Colin J.

AU - Molitch, Mark E.

AU - Pergola, Pablo E.

AU - Raskin, Philip

AU - Silva, Arnold L.

AU - Spinowitz, Bruce

AU - Sprague, Stuart M.

AU - Rossing, Peter

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N2 - Aims: Obesity is associated with progression of chronic kidney disease (CKD). Treatment with bardoxolone methyl in a multinational phase 3 trial, Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes (BEACON), resulted in increases in estimated glomerular filtration rate (eGFR) with concurrent reductions in body weight. We performed post-hoc analyses to further characterize reductions in body weight with bardoxolone methyl. Methods: Eligible patients with type 2 diabetes (T2DM) and CKD stage 4 (eGFR 15 to <30 mL/min/1.73 m2) were randomized 1:1 to receive once-daily oral dose of bardoxolone methyl (20 mg) or placebo. Results: BEACON enrolled 2185 patients. Patients randomized to bardoxolone methyl experienced significant reductions in body weight from baseline relative to patients randomized to placebo (−5.7 kg; 95% CI: −6.0 to −5.3 kg; p < 0.001). In patients randomized to bardoxolone methyl, rate and magnitude of body weight loss were proportional to baseline BMI. Bardoxolone methyl resulted in significant reductions in waist circumference and improved glycemic control. Conclusions: Bardoxolone methyl resulted in significant weight loss in a generally obese patient population with T2DM and stage 4 CKD, with the magnitude and rate dependent on baseline BMI.

AB - Aims: Obesity is associated with progression of chronic kidney disease (CKD). Treatment with bardoxolone methyl in a multinational phase 3 trial, Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes (BEACON), resulted in increases in estimated glomerular filtration rate (eGFR) with concurrent reductions in body weight. We performed post-hoc analyses to further characterize reductions in body weight with bardoxolone methyl. Methods: Eligible patients with type 2 diabetes (T2DM) and CKD stage 4 (eGFR 15 to <30 mL/min/1.73 m2) were randomized 1:1 to receive once-daily oral dose of bardoxolone methyl (20 mg) or placebo. Results: BEACON enrolled 2185 patients. Patients randomized to bardoxolone methyl experienced significant reductions in body weight from baseline relative to patients randomized to placebo (−5.7 kg; 95% CI: −6.0 to −5.3 kg; p < 0.001). In patients randomized to bardoxolone methyl, rate and magnitude of body weight loss were proportional to baseline BMI. Bardoxolone methyl resulted in significant reductions in waist circumference and improved glycemic control. Conclusions: Bardoxolone methyl resulted in significant weight loss in a generally obese patient population with T2DM and stage 4 CKD, with the magnitude and rate dependent on baseline BMI.

KW - Bardoxolone methyl

KW - Chronic kidney disease

KW - HbA

KW - Metabolic effects

KW - Obesity

KW - Randomized clinical trial

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