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Pratley, RE; Husain, M; Lingvay, I; Pieber, TR; Mark, T; Saevereid, HA; Møller, DV; Zinman, B; DEVOTE Study Group.
Heart failure with insulin degludec versus glargine U100 in patients with type 2 diabetes at high risk of cardiovascular disease: DEVOTE 14.
Cardiovasc Diabetol. 2019; 18(1):156-156
Doi: 10.1186/s12933-019-0960-8
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- Co-authors Med Uni Graz
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Pieber Thomas
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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.
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.
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]95% CI, p = 0.227). Prior HF (HR 4.89 [3.90;6.14]95% CI, 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.
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.
- Find related publications in this database (using NLM MeSH Indexing)
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Aged -
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Biomarkers - blood
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Blood Glucose - drug effects
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Blood Glucose - metabolism
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Diabetes Mellitus, Type 2 - blood
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Diabetes Mellitus, Type 2 - diagnosis
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Diabetes Mellitus, Type 2 - drug therapy
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Diabetes Mellitus, Type 2 - epidemiology
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Disease Progression -
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Double-Blind Method -
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Female -
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Heart Failure - diagnosis
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Heart Failure - epidemiology
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Heart Failure - therapy
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Humans -
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Hypoglycemia - blood
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Hypoglycemia - chemically induced
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Hypoglycemia - epidemiology
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Hypoglycemic Agents - adverse effects
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Hypoglycemic Agents - therapeutic use
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Insulin Glargine - adverse effects
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Insulin Glargine - therapeutic use
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Insulin, Long-Acting - adverse effects
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Insulin, Long-Acting - therapeutic use
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Male -
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Middle Aged -
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Patient Admission -
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Prospective Studies -
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Risk Assessment -
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Risk Factors -
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Time Factors -
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Treatment Outcome -
- Find related publications in this database (Keywords)
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Clinical trial
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Hospitalization for heart failure
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Severe hypoglycemia
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Insulin degludec
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Type 2 diabetes