Chronic Kidney Disease (CKD) and Risk of Mortality, Cardiovascular (CV) Events, and Severe Hypoglycemia in Type 2 Diabetes (T2D)-DEVOTE Results
Authors: AMOD ASLAM , EMERSON SCOTT S. , MARSO STEVEN P. , MCGUIRE DARREN K. , PIEBER THOMAS R. , POP-BUSUI RODICA , PRATLEY RICHARD E. , ZINMAN BERNARD , HANSEN MELISSA V. , JIA TING , MARK THOMAS , POULTER NEIL R. ,   ON BEHALF OF THE DEVOTE STUDY GROUP
Published: June 2018

T2D is associated with an increased risk of cardiovascular disease (CVD) and CKD. CKD is a known risk factor for major adverse cardiovascular events (MACE), all-cause mortality and hypoglycemia. This secondary, pooled analysis from DEVOTE examined whether baseline CKD stages were associated with an increased risk of MACE, all-cause mortality or severe hypoglycemia in T2D patients. DEVOTE was a treat-to-target, randomized, double-blind trial in 7637 patients with T2D at high CV risk, treated once daily with insulin degludec or insulin glargine 100 units/mL. According to baseline CKD stages (CKD stage 2: n=3118; stage 3: n=2704; stages 4+5: n=214), more patients had a history of CVD (CKD stages 3–5), were older and had lower A1C vs. those with normal kidney function (normal + CKD stage 1, n=1486). Risk of MACE and all-cause mortality was significantly higher (p&lt;0.05) in those with a higher baseline CKD stage (Figure). There was a significantly higher rate of severe hypoglycemia for stages 3 and 4+5 vs. stage 2 or normal + stage 1. There were no significant interactions between treatment and CKD stages. Comparisons between treatment groups by CKD stage mirrored those from the primary analyses. Increasing severity of baseline CKD stages was associated with a higher risk of MACE, all-cause mortality and severe hypoglycemia in T2D patients at high CV risk.

Disclosure
A. Amod: Advisory Panel; Self; Novo Nordisk A/S, AstraZeneca, Merck Sharp & Dohme Corp., Merck Serono, Boehringer Ingelheim Pharmaceuticals, Inc., Aspen Pharmacare, Sanofi-Aventis. Consultant; Self; Servier, Medscheme, Discovery Health. Speaker's Bureau; Self; Novo Nordisk A/S, AstraZeneca, Merck Sharp & Dohme Corp., Merck Serono, Boehringer Ingelheim Pharmaceuticals, Inc., Aspen Pharmacare, Sanofi-Aventis, Novartis AG, Ascendis Health, Cipla Medpro. S.S. Emerson: Consultant; Self; Bayer AG, CTI BioPharma, Arena Pharmaceuticals, SFJ Pharmaceuticals Group, Genentech, Inc., GlaxoSmithKline plc., Janssen Research & Development, Novartis AG, Novo Nordisk A/S, Pfizer Inc., Roche Pharma, Allergan, AstraZeneca, Coherus Biosciences Inc, Emmaus Life Sciences Inc., Indivior, Sandoz, Seattle Genetics. Research Support; Self; National Heart, Lung, and Blood Institute. S.P. Marso: Consultant; Self; Abbott Vascular, Novo Nordisk A/S, University of Oxford, AstraZeneca, Bristol-Myers Squibb Company. Research Support; Self; Novo Nordisk A/S, The Medicines Company, Terumo Medical Corporation. D.K. McGuire: Consultant; Self; AstraZeneca, Sanofi-Aventis, Eli Lilly and Company, Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc., Pfizer Inc., Novo Nordisk A/S. Research Support; Self; AstraZeneca, Sanofi-Aventis, Janssen Pharmaceuticals, Inc., Boehringer Ingelheim Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S, Lexicon Pharmaceuticals, Inc., Eisai Inc., GlaxoSmithKline plc., Esperion Therapeutics. T.R. Pieber: Consultant; Self; Arecor, AstraZeneca, Eli Lilly and Company, Novo Nordisk A/S, Sanofi. Employee; Self; CBmed. Research Support; Self; Novo Nordisk A/S, AstraZeneca. R. Pop-Busui: Research Support; Self; AstraZeneca. R.E. Pratley: Other Relationship; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eisai Inc., GlaxoSmithKline plc., Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Ligand Pharmaceuticals, Inc., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk Inc., Pfizer Inc., Sanofi-Aventis, Takeda Development Center Americas, Inc. B. Zinman: Consultant; Self; Novo Nordisk A/S, Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Sanofi, Merck & Co., Inc., Abbott. M.V. Hansen: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. T. Jia: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. T. Mark: Employee; Self; Novo Nordisk A/S. Employee; Spouse/Partner; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. N.R. Poulter: Advisory Panel; Self; AstraZeneca, Novo Nordisk A/S, Amgen Inc.. Research Support; Self; Servier. Speaker's Bureau; Self; AstraZeneca, Novo Nordisk A/S, Amgen Inc., Servier. Other Relationship; Self; International Society of Hypertension.