Published in:
Open Access 01-01-2020 | Insulin Glargine | Original Research
Glomerular Filtration Rate and Associated Risks of Cardiovascular Events, Mortality, and Severe Hypoglycemia in Patients with Type 2 Diabetes: Secondary Analysis (DEVOTE 11)
Published in: Diabetes Therapy | Issue 1/2020
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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.