Baseline characteristics in the bardoxolone methyl evaluation in patients with chronic kidney disease and type 2 diabetes mellitus: the Occurrence of renal eveNts (BEACON) trial

Lambers Heerspink, H.J. et al. (2013) Baseline characteristics in the bardoxolone methyl evaluation in patients with chronic kidney disease and type 2 diabetes mellitus: the Occurrence of renal eveNts (BEACON) trial. Nephrology Dialysis Transplantation, 28(11), pp. 2841-2850. (doi: 10.1093/ndt/gft445) (PMID:24169612)

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Abstract

Background Type 2 diabetes mellitus (T2DM) is the most important contributing cause of end-stage renal disease (ESRD) worldwide. Bardoxolone methyl, a nuclear factor-erythroid-2-related factor 2 activator, augments estimated glomerular filtration. The Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes mellitus: the Occurrence of renal eveNts (BEACON) trial was designed to establish whether bardoxolone methyl slows or prevents progression to ESRD. Herein, we describe baseline characteristics of the BEACON population.<p></p> Methods BEACON is a randomized double-blind placebo-controlled clinical trial in 2185 patients with T2DM and chronic kidney disease stage 4 (eGFR between 15 and 30 mL/min/1.73 m2) designed to test the hypothesis that bardoxolone methyl added to guideline-recommended treatment including inhibitors of the renin–angiotensin–aldosterone system slows or prevents progression to ESRD or cardiovascular death compared with placebo.<p></p> Results Baseline characteristics (mean or percentage) of the population include age 68.5 years, female 43%, Caucasian 78%, eGFR 22.5 mL/min/1.73 m2 and systolic/diastolic blood pressure 140/70 mmHg. The median urinary albumin:creatinine ratio was 320 mg/g and the frequency of micro- and macroalbuminuria was 30 and 51%, respectively. Anemia, abnormalities in markers of bone metabolism and elevations in cardiovascular biomarkers were frequently observed. A history of cardiovascular disease was present in 56%, neuropathy in 47% and retinopathy in 41% of patients.<p></p> Conclusions The BEACON trial enrolled a population heretofore unstudied in an international randomized controlled trial. Enrolled patients suffered with numerous co-morbid conditions and exhibited multiple laboratory abnormalities, highlighting the critical need for new therapies to optimize management of these conditions.<p></p>

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:McMurray, Professor John
Authors: Lambers Heerspink, H.J., Chertow, G.M., Akizawa, T., Audhya, P., Bakris, G.L., Goldsberry, A., Krauth, M., Linde, P., McMurray, J.J., Meyer, C.J., Parving, H.-H., Remuzzi, G., Christ-Schmidt, H., Toto, R.D., Vaziri, N.D., Wanner, C., Wittes, J., Wrolstad, D., and de Zeeuw, D.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cardiovascular and Medical Sciences
Journal Name:Nephrology Dialysis Transplantation
Publisher:Oxford University Press
ISSN:0931-0509
ISSN (Online):1460-2385

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