TY - JOUR
T1 - Baseline characteristics in the Bardoxolone methyl EvAluation in patients with Chronic kidney disease and type 2 diabetes mellitus
T2 - The Occurrence of renal eveNts (BEACON) trial
AU - Heerspink, Hiddo J Lambers
AU - Chertow, Glenn M.
AU - Akizawa, Tadao
AU - Audhya, Paul
AU - Bakris, George L.
AU - Goldsberry, Angie
AU - Krauth, Melissa
AU - Linde, Peter
AU - McMurray, John J.
AU - Meyer, Colin J.
AU - Parving, Hans Henrik
AU - Remuzzi, Giuseppe
AU - Christ-Schmidt, Heidi
AU - Toto, Robert D.
AU - Vaziri, Nosratola D.
AU - Wanner, Christoph
AU - Wittes, Janet
AU - Wrolstad, Danielle
AU - De Zeeuw, Dick
PY - 2013/11
Y1 - 2013/11
N2 - 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. 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/1.73m2) 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. 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. 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.
AB - 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. 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/1.73m2) 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. 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. 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.
KW - BEACON
KW - Bardoxolone
KW - Diabetic nephropathy
KW - RCT
UR - http://www.scopus.com/inward/record.url?scp=84890067870&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84890067870&partnerID=8YFLogxK
U2 - 10.1093/ndt/gft445
DO - 10.1093/ndt/gft445
M3 - Article
C2 - 24169612
AN - SCOPUS:84890067870
SN - 0931-0509
VL - 28
SP - 2841
EP - 2850
JO - Nephrology Dialysis Transplantation
JF - Nephrology Dialysis Transplantation
IS - 11
ER -