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@article{Pieber:2017:10.1007/s00125-017-4422-0,
author = {Pieber, TR and Marso, SP and McGuire, DK and Zinman, B and Poulter, NR and Emerson, SS and Pratley, RE and Woo, V and Heller, S and Lange, M and Brown-Frandesen, K and Moses, A and Barner, Lekdorf J and Lehmann, L and Kvist, K and Buse, JB and DEVOTE, Study Group},
doi = {10.1007/s00125-017-4422-0},
journal = {Diabetologia},
pages = {58--65},
title = {DEVOTE 3: Temporal relationships between severe hypoglycaemia, cardiovascular outcomes and mortality},
url = {http://dx.doi.org/10.1007/s00125-017-4422-0},
volume = {61},
year = {2017}
}

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TY  - JOUR
AB  - Aims/hypothesisThe double-blind Trial Comparing Cardiovascular Safety of Insulin Degludec vs Insulin Glargine in Patients with Type 2 Diabetes at High Risk of Cardiovascular Events (DEVOTE) assessed the cardiovascular safety of insulin degludec. The incidence and rates of adjudicated severe hypoglycaemia, and all-cause mortality were also determined. This paper reports a secondary analysis investigating associations of severe hypoglycaemia with cardiovascular outcomes and mortality.MethodsIn DEVOTE, patients with type 2 diabetes were randomised to receive either insulin degludec or insulin glargine U100 (100 units/ml) once daily (between dinner and bedtime) in an event-driven, double-blind, treat-to-target cardiovascular outcomes trial. The primary outcome was the first occurrence of an adjudicated major adverse cardiovascular event (MACE; cardiovascular death, non-fatal myocardial infarction or non-fatal stroke). Adjudicated severe hypoglycaemia was the pre-specified secondary outcome. In the present analysis, the associations of severe hypoglycaemia with both MACE and all-cause mortality was evaluated in the pooled trial population using time-to-event analyses, with severe hypoglycaemia as a time-dependent variable and randomised treatment as a fixed factor. An investigation with interaction terms indicated that the effect of severe hypoglycaemia on the risk of MACE and all-cause mortality were the same for both treatment arms, and so the temporal association for severe hypoglycaemia with subsequent MACE and all-cause mortality is reported for the pooled population.ResultsThere was a non-significant difference in the risk of MACE for individuals who had vs those who had not experienced severe hypoglycaemia during the trial (HR 1.38, 95% CI 0.96, 1.96; p = 0.080) and therefore there was no temporal relationship between severe hypoglycaemia and MACE. There was a significantly higher risk of all-cause mortality for patients who had vs those who had not experienced se
AU  - Pieber,TR
AU  - Marso,SP
AU  - McGuire,DK
AU  - Zinman,B
AU  - Poulter,NR
AU  - Emerson,SS
AU  - Pratley,RE
AU  - Woo,V
AU  - Heller,S
AU  - Lange,M
AU  - Brown-Frandesen,K
AU  - Moses,A
AU  - Barner,Lekdorf J
AU  - Lehmann,L
AU  - Kvist,K
AU  - Buse,JB
AU  - DEVOTE,Study Group
DO  - 10.1007/s00125-017-4422-0
EP  - 65
PY  - 2017///
SN  - 0012-186X
SP  - 58
TI  - DEVOTE 3: Temporal relationships between severe hypoglycaemia, cardiovascular outcomes and mortality
T2  - Diabetologia
UR  - http://dx.doi.org/10.1007/s00125-017-4422-0
UR  - http://hdl.handle.net/10044/1/50410
VL  - 61
ER  -

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