scholarly journals Bardoxolone Methyl in Type 2 Diabetes and Stage 4 Chronic Kidney Disease

2013 ◽  
Vol 369 (26) ◽  
pp. 2492-2503 ◽  
Author(s):  
Dick de Zeeuw ◽  
Tadao Akizawa ◽  
Paul Audhya ◽  
George L. Bakris ◽  
Melanie Chin ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Stage 4

scholarly journals Effects of Bardoxolone Methyl on Magnesium in Patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease

2019 ◽  
Vol 9 (5) ◽  
pp. 316-325 ◽  
Author(s):  
Dana V. Rizk ◽  
Arnold L. Silva ◽  
Pablo E. Pergola ◽  
Robert Toto ◽  
David G. Warnock ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Serum Magnesium ◽  
Open Label ◽  
Stage 4 ◽  
Renal Magnesium Wasting ◽  
Total Body ◽  
To Receive

Background: Treatment with bardoxolone methyl (Bard) 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 with concurrent reductions in serum magnesium. We analyzed data from several trials to characterize reductions in magnesium with Bard. Methods: BEACON randomized patients (n = 2,185) with type 2 diabetes (T2DM) and stage 4 chronic kidney disease (CKD) 1:1 to receive Bard (20 mg) or placebo once daily. In a separate open-label study, magnesium levels from 24-hour urine and sublingual epithelial cell samples were analyzed in patients with stage 3b-4 CKD and T2DM administered 20 mg Bard for 56 consecutive days. Results: BEACON patients randomized to Bard experienced significant reductions in serum magnesium from baseline relative to patients randomized to placebo (–0.17 mEq/L, 95% CI –0.18 to –0.60 mEq/L; p < 0.001). A separate study showed intracellular and urinary magnesium levels were unchanged with Bard treatment. Conclusions: Bard treatment results in significant decreases in serum magnesium that are not associated with changes in intracellular and urinary magnesium levels, indicating that magnesium decreases are not due to renal magnesium wasting or total body magnesium depletion. Importantly, the decreases in serum magnesium with Bard are not associated with adverse effects on QT interval.

scholarly journals Bardoxolone Methyl Improves Kidney Function in Patients with Chronic Kidney Disease Stage 4 and Type 2 Diabetes: Post-Hoc Analyses from Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes Study

2018 ◽  
Vol 47 (1) ◽  
pp. 40-47 ◽  
Author(s):  
Melanie P. Chin ◽  
George L. Bakris ◽  
Geoffrey A. Block ◽  
Glenn M. Chertow ◽  
Angie Goldsberry ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Kidney Function ◽  
Chronic Kidney Disease Stage ◽  
Disease Stage ◽  
Stage 4 ◽  
Ckd Stage ◽  
Post Hoc

Background: Increases in measured inulin clearance, measured creatinine clearance, and estimated glomerular filtration rate (eGFR) have been observed with bardoxolone methyl in 7 studies enrolling approximately 2,600 patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). The largest of these studies was Bardoxolone Methyl Evaluation in Patients with Chronic Kidney Disease and Type 2 Diabetes (BEACON), a multinational, randomized, double-blind, placebo-controlled phase 3 trial which enrolled patients with T2D and CKD stage 4. The BEACON trial was terminated after preliminary analyses showed that patients randomized to bardoxolone methyl experienced significantly higher rates of heart failure events. We performed post-hoc analyses to characterize changes in kidney function induced by bardoxolone methyl. Methods: Patients in ­BEACON (n = 2,185) were randomized 1: 1 to receive once-daily bardoxolone methyl (20 mg) or placebo. We compared the effects of bardoxolone methyl and placebo on a post-hoc composite renal endpoint consisting of ≥30% decline from baseline in eGFR, eGFR <15 mL/min/1.73 m2, and end-stage renal disease (ESRD) events (provision of dialysis or kidney transplantation). Results: Consistent with prior studies, patients randomized to bardoxolone methyl experienced mean increases in eGFR that were sustained through study week 48. Moreover, increases in eGFR from baseline were sustained 4 weeks after cessation of treatment. Patients randomized to bardoxolone methyl were significantly less likely to experience the composite renal endpoint (hazards ratio 0.48 [95% CI 0.36–0.64]; p < 0.0001). Conclusions: Bardoxolone methyl preserves kidney function and may delay the onset of ESRD in patients with T2D and stage 4 CKD.

scholarly journals FO022BARDOXOLONE METHYL PREVENTS EGFR DECLINE IN PATIENTS WITH CHRONIC KIDNEY DISEASE STAGE 4 AND TYPE 2 DIABETES - POST-HOC ANALYSES FROM BEACON

2018 ◽  
Vol 33 (suppl_1) ◽  
pp. i10-i10
Author(s):  
Christoph Wanner ◽  
George Bakris ◽  
Geoffrey Block ◽  
Melanie Chin ◽  
Angie Goldsberry ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Chronic Kidney Disease Stage ◽  
Disease Stage ◽  
Stage 4 ◽  
Post Hoc ◽  
Egfr Decline

scholarly journals Effect of bardoxolone methyl on the urine albumin-to-creatinine ratio in patients with type 2 diabetes and stage 4 chronic kidney disease

2019 ◽  
Vol 96 (4) ◽  
pp. 1030-1036 ◽  
Author(s):  
Peter Rossing ◽  
Geoffrey A. Block ◽  
Melanie P. Chin ◽  
Angie Goldsberry ◽  
Hiddo J.L. Heerspink ◽  
...  
Keyword(s):  
Type 2 Diabetes ◽  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Creatinine Ratio ◽  
Urine Albumin ◽  
Stage 4
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