Glomerular Filtration Rate and Associated Risks of Cardiovascular Events, Mortality, and Severe Hypoglycemia in Patients with Type 2 Diabetes: Secondary Analysis (DEVOTE 11)

Aslam Amod, John B. Buse, Darren K. McGuire, Thomas R. Pieber, Rodica Pop-Busui, Richard E. Pratley, Bernard Zinman, Marco Bo Hansen, Ting Jia, Thomas Mark, Neil R. Poulter, DEVOTE Study Group the DEVOTE Study Group

Research output: Contribution to journalArticle

2 Scopus citations

Abstract

Introduction: The associations of chronic kidney disease (CKD) severity, cardiovascular disease (CVD), and insulin with the risks of major adverse cardiovascular events (MACE), mortality, and severe hypoglycemia in patients with type 2 diabetes (T2D) at high cardiovascular (CV) risk are not known. This secondary, pooled analysis of data from the DEVOTE trial examined whether baseline glomerular filtration rate (GFR) categories were associated with a higher risk of these outcomes. Methods: DEVOTE was a treat-to-target, double-blind trial involving 7637 patients with T2D at high CV risk who were randomized to once-daily treatment with either insulin degludec (degludec) or insulin glargine 100 units/mL (glargine U100). Patients with estimated GFR data at baseline (n = 7522) were analyzed following stratification into four GFR categories. Results: The risks of MACE, CV death, and all-cause mortality increased with worsening baseline GFR category (P < 0.05), with a trend towards higher rates of severe hypoglycemia. Patients with prior CVD, CKD (estimated GFR < 60 mL/min/m2), or both were at higher risk of MACE, CV death, and all-cause mortality. Only CKD was associated with a higher rate of severe hypoglycemia, and the risk of MACE was higher in patients with CVD than in those with CKD (P = 0.0003). There were no significant interactions between randomized treatment and GFR category. Conclusion: The risks of MACE, CV death, and all-cause mortality were higher with lower baseline GFR and with prior CVD, CKD, or both. The relative effects of degludec versus glargine U100 on outcomes were consistent across baseline GFR categories, suggesting that the lower rate of severe hypoglycemia associated with degludec use versus glargine U100 use was independent of baseline GFR category. Funding: Novo Nordisk.

Original languageEnglish (US)
JournalDiabetes Therapy
DOIs
StateAccepted/In press - Jan 1 2019

Keywords

  • Basal insulin analogs
  • Cardiovascular disease
  • Chronic kidney disease
  • Glomerular filtration rate
  • Insulin degludec
  • Insulin glargine U100
  • Severe hypoglycemia
  • Type 2 diabetes

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

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    Amod, A., Buse, J. B., McGuire, D. K., Pieber, T. R., Pop-Busui, R., Pratley, R. E., Zinman, B., Hansen, M. B., Jia, T., Mark, T., Poulter, N. R., & the DEVOTE Study Group, DEVOTE. S. G. (Accepted/In press). Glomerular Filtration Rate and Associated Risks of Cardiovascular Events, Mortality, and Severe Hypoglycemia in Patients with Type 2 Diabetes: Secondary Analysis (DEVOTE 11). Diabetes Therapy. https://doi.org/10.1007/s13300-019-00715-x