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Heart failure with insulin degludec versus glargine U100 in patients with type 2 diabetes at high risk of cardiovascular disease: DEVOTE 14.
- Source :
-
Cardiovascular diabetology [Cardiovasc Diabetol] 2019 Nov 15; Vol. 18 (1), pp. 156. Date of Electronic Publication: 2019 Nov 15. - Publication Year :
- 2019
-
Abstract
- Background: Heart failure (HF) is a common cardiovascular complication of type 2 diabetes (T2D). This secondary analysis investigated baseline factors and treatment differences associated with risk of hospitalization for HF (hHF), and the possible association between severe hypoglycemia and hHF.<br />Methods: DEVOTE was a treat-to-target, double-blind cardiovascular outcomes trial in patients (n = 7637) with T2D and high cardiovascular risk randomized to insulin degludec (degludec) or insulin glargine 100 units/mL (glargine U100). The main endpoint of this secondary analysis was time to first hHF (standardized MedDRA Query definition). Severe hypoglycemia was adjudicated (American Diabetes Association definition). The main endpoint and the temporal association between severe hypoglycemia and hHF were analyzed with a Cox proportional hazards regression model. Predictors of time to first hHF were identified using baseline variables.<br />Results: Overall, 372 (4.9%) patients experienced hHF (550 events). There was no significant difference in the risk of hHF between treatments (hazard ratio [HR] 0.88 [0.72;1.08] <subscript>95% CI</subscript> , p = 0.227). Prior HF (HR 4.89 [3.90;6.14] <subscript>95% CI</subscript> , p ≤ 0.0001) was the strongest predictor of future hHF events. The risk of hHF significantly increased after (HR 2.2), and within a week after (HR 11.1), experiencing a severe hypoglycemic episode compared with before an episode.<br />Conclusions: In patients with T2D and high cardiovascular risk there were no treatment differences in terms of hHF. Prior HF was the strongest predictor of future hHF events, and there was an association between severe hypoglycemia and subsequent hHF. Further research should evaluate whether the risk of hHF can be modified by treatments aimed at reducing hypoglycemia. Trial Registration NCT01959529.
- Subjects :
- Aged
Biomarkers blood
Blood Glucose metabolism
Diabetes Mellitus, Type 2 blood
Diabetes Mellitus, Type 2 diagnosis
Diabetes Mellitus, Type 2 epidemiology
Disease Progression
Double-Blind Method
Female
Heart Failure diagnosis
Heart Failure epidemiology
Humans
Hypoglycemia blood
Hypoglycemia chemically induced
Hypoglycemia epidemiology
Hypoglycemic Agents adverse effects
Insulin Glargine adverse effects
Insulin, Long-Acting adverse effects
Male
Middle Aged
Prospective Studies
Risk Assessment
Risk Factors
Time Factors
Treatment Outcome
Blood Glucose drug effects
Diabetes Mellitus, Type 2 drug therapy
Heart Failure therapy
Hypoglycemic Agents therapeutic use
Insulin Glargine therapeutic use
Insulin, Long-Acting therapeutic use
Patient Admission
Subjects
Details
- Language :
- English
- ISSN :
- 1475-2840
- Volume :
- 18
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Cardiovascular diabetology
- Publication Type :
- Academic Journal
- Accession number :
- 31729990
- Full Text :
- https://doi.org/10.1186/s12933-019-0960-8