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Heller, S; Lingvay, I; Marso, SP; Philis-Tsimikas, A; Pieber, TR; Poulter, NR; Pratley, RE; Hachmann-Nielsen, E; Kvist, K; Lange, M; Moses, AC; Andresen, MT; Buse, JB; DEVOTE Study Group.
Risk of severe hypoglycaemia and its impact in type 2 diabetes in DEVOTE.
Diabetes Obes Metab. 2020;
Doi: 10.1111/dom.14049
[OPEN ACCESS]
Web of Science
PubMed
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- Co-Autor*innen der Med Uni Graz
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Pieber Thomas
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- Abstract:
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To undertake a post hoc analysis, utilizing a hypoglycaemia risk score based on DEVOTE trial data, to investigate if a high risk of severe hypoglycaemia was associated with an increased risk of cardiovascular events, and whether reduced rates of severe hypoglycaemia in patients identified as having the highest risk impacted the risk of cardiovascular outcomes.
The DEVOTE population was divided into quartiles according to patients' individual hypoglycaemia risk scores. For each quartile, the observed incidence and rate of severe hypoglycaemia, major adverse cardiovascular event (MACE) and all-cause mortality were determined to investigate whether those with the highest risk of hypoglycaemia were also at the greatest risk of MACE and all-cause mortality. In addition, treatment differences within each risk quartile (insulin degludec [degludec] vs insulin glargine 100 units/mL [glargine U100]) in terms of severe hypoglycaemia, MACE and all-cause mortality were also investigated.
Patients with the highest risk scores had the highest rates of severe hypoglycaemia, MACE and all-cause mortality. Treatment ratios between degludec and glargine U100 in the highest risk quartile were 0.56 [0.39;0.80]95%CI (severe hypoglycaemia), 0.76 [0.58;0.99]95%CI (MACE) and 0.77 [0.55;1.07]95%CI (all-cause mortality).
The risk score demonstrated that a high risk of severe hypoglycaemia was associated with a high incidence of MACE and all-cause mortality and that, in this high-risk group, those treated with degludec had a lower incidence of MACE. These observations support the hypothesis that hypoglycaemia is a risk factor for cardiovascular events.
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all-cause mortality
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MACE
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severe hypoglycaemia
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type 2 diabetes