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  • Chin, Melanie  (17)
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  • 1
    In: Nephrology Dialysis Transplantation, 2018, Vol. 33(suppl1), pp.i635-i635
    ISSN: 0931-0509
    E-ISSN: 1460-2385
    Source: Oxford University Press
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  • 2
    In: The New England Journal of Medicine, 2013, Vol.369(26), pp.2492-2503
    Description: Background Although inhibitors of the renin–angiotensin–aldosterone system can slow the progression of diabetic kidney disease, the residual risk is high. Whether nuclear 1 factor (erythroid-derived 2)–related factor 2 activators further reduce this risk is unknown. Methods We randomly assigned 2185 patients with type 2 diabetes mellitus and stage 4 chronic kidney disease (estimated glomerular filtration rate [GFR], 15 to 〈30 ml per minute per 1.73 m 2 of body-surface area) to bardoxolone methyl, at a daily dose of 20 mg, or placebo. The primary composite outcome was end-stage renal disease (ESRD) or death from cardiovascular causes. Results The sponsor and the steering committee terminated the trial on the recommendation of the independent data and safety monitoring committee; the median follow-up was 9 months. A total of 69 of 1088 patients (6%) randomly assigned to bardoxolone methyl and 69 of 1097 (6%) randomly assigned to placebo had a primary composite outcome (hazard ratio in the bardoxolone methyl group vs. the placebo group, 0.98; 95% confidence interval [CI], 0.70 to 1.37; P=0.92). In the bardoxolone methyl group, ESRD developed in 43 patients, and 27 patients died from cardiovascular causes; in the placebo group, ESRD developed in 51 patients, and 19 patients died from cardiovascular causes. A total of 96 patients in the bardoxolone methyl group were hospitalized for heart failure or died from heart failure, as compared with 55 in the placebo group (hazard ratio, 1.83; 95% CI, 1.32 to 2.55; P〈0.001). Estimated GFR, blood pressure, and the urinary albumin-to-creatinine ratio increased significantly and body weight decreased significantly in the bardoxolone methyl group, as compared with the placebo group. Conclusions 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 .) Among patients with type 2 diabetes and stage 4 chronic kidney disease, bardoxolone methyl, as compared with placebo, did not reduce the risk of end-stage renal disease or cardiovascular death. Cardiovascular events in the bardoxolone group prompted trial termination. Type 2 diabetes mellitus is the most important cause of progressive chronic kidney disease in the developed and developing worlds. Various therapeutic approaches to slow progression, including restriction of dietary protein, glycemic control, and control of hypertension, have yielded mixed results.1–3 Several randomized clinical trials have shown that inhibitors of the renin–angiotensin–aldosterone system significantly reduce the risk of progression,4–6 although the residual risk remains high.7 None of the new agents tested during the past decade have proved effective in late-stage clinical trials.8–12 Oxidative stress and impaired antioxidant capacity intensify with the progression of chronic kidney disease.13 In . . .
    Keywords: Medicine;
    ISSN: 0028-4793
    E-ISSN: 1533-4406
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  • 3
    Language: English
    In: Chest, October 2015, Vol.148(4), pp.639A-639A
    Keywords: Medicine
    ISSN: 0012-3692
    E-ISSN: 1931-3543
    Source: ScienceDirect Journals (Elsevier)
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  • 4
    Language: English
    In: American journal of physiology. Renal physiology, 15 June 2013, Vol.304(12), pp.F1438-46
    Description: Bardoxolone methyl and related triterpenoids are well tolerated and efficacious in numerous animal models potentially relevant to patients with Type 2 diabetes and chronic kidney disease. These agents enhance glucose control and regulate lipid accumulation in rodent models of diabetes and obesity, and improve renal function, reduce inflammation, and prevent structural injury in models of renal disease. However, a recent study in Zucker diabetic fatty (ZDF) rats noted poor tolerability with the bardoxolone methyl analog RTA 405 within 1 mo after treatment initiation, although this study was confounded in part by the use of an impure RTA 405 batch. To investigate these discordant observations, the present studies were conducted to further characterize triterpenoids in rodent models of diabetes and obesity. A follow-up study was conducted in ZDF rats with two related triterpenoids (RTA 405 and dh404) for 1.5 mo. Consistent with previous rodent experience, and in contrast to the more recent ZDF report, ZDF rats administered RTA 405 or dh404 exhibited no adverse clinical signs, had laboratory values similar to controls, and exhibited no evidence of adverse liver or kidney histopathology. Additionally, RTA 405 was well tolerated in streptozotocin-induced Type 1 diabetic rats and high-fat-diet-induced obese mice. The present results are consistent with the overall published body of data obtained with triterpenoids and provide further evidence that these molecules are well tolerated without adverse effects on hepatobiliary or renal function in rodent models of diabetes and obesity.
    Keywords: Type 2 Diabetes ; Bardoxolone Methyl ; Diabetes Mellitus, Experimental -- Drug Therapy ; Diabetes Mellitus, Type 2 -- Drug Therapy ; Obesity -- Drug Therapy ; Oleanolic Acid -- Analogs & Derivatives
    E-ISSN: 1522-1466
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  • 5
    In: Nephrology Dialysis Transplantation, 2017, Vol. 32(suppl3), pp.iii480-iii480
    ISSN: 0931-0509
    E-ISSN: 1460-2385
    Source: Oxford University Press
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  • 6
    In: Nephrology Dialysis Transplantation, 2018, Vol. 33(suppl1), pp.i10-i10
    ISSN: 0931-0509
    E-ISSN: 1460-2385
    Source: Oxford University Press
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  • 7
    Language: English
    In: American Journal of Physiology (Consolidated), 2013, Vol.304(6), p.F1438(9)
    Description: Bardoxolone methyl and related triterpenoids are well tolerated and efficacious in numerous animal models potentially relevant to patients with Type 2 diabetes and chronic kidney disease. These agents enhance glucose control and regulate lipid accumulation in rodent models of diabetes and obesity, and improve renal function, reduce inflammation, and prevent structural injury in models of renal disease. However, a recent study in Zucker diabetic fatty (ZDF) rats noted poor tolerability with the bardoxolone methyl analog RTA 405 within 1 mo after treatment initiation, although this study was confounded in part by the use of an impure RTA 405 batch. To investigate these discordant observations, the present studies were conducted to further characterize triterpenoids in rodent models of diabetes and obesity. A follow-up study was conducted in ZDF rats with two related triterpenoids (RTA 405 and dh404) for 1.5 mo. Consistent with previous rodent experience, and in contrast to the more recent ZDF report, ZDF rats administered RTA 405 or dh404 exhibited no adverse clinical signs, had laboratory values similar to controls, and exhibited no evidence of adverse liver or kidney histopathology. Additionally, RTA 405 was well tolerated in streptozotocin-induced Type 1 diabetic rats and high-fat-diet-induced obese mice. The present results are consistent with the overall published body of data obtained with triterpenoids and provide further evidence that these molecules are well tolerated without adverse effects on hepatobiliary or renal function in rodent models of diabetes and obesity. bardoxolone methyl; Type 2 diabetes doi: 10.1152/ajprenal.00387.2012
    Keywords: Animal Research Models – Usage ; Obesity – Care and Treatment ; Obesity – Genetic Aspects ; Obesity – Research ; Terpenoids – Usage ; Terpenoids – Health Aspects ; Type 2 Diabetes – Drug Therapy ; Type 2 Diabetes – Research
    ISSN: 0002-9513
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  • 8
  • 9
    In: Nephrology Dialysis Transplantation, 2018, Vol. 33(suppl1), pp.i14-i14
    Keywords: Medicine;
    ISSN: 0931-0509
    E-ISSN: 1460-2385
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  • 10
    In: Nephrology Dialysis Transplantation, 2018, Vol. 33(suppl1), pp.i634-i634
    ISSN: 0931-0509
    E-ISSN: 1460-2385
    Source: Oxford University Press
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