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@article{Mentz:2018:10.1161/JAHA.118.009304,
author = {Mentz, RJ and Bethel, MA and Merrill, P and Lokhnygina, Y and Buse, JB and Chan, JC and Felício, JS and Goodman, SG and Choi, J and Gustavson, SM and Iqbal, N and Lopes, RD and Maggioni, AP and Öhman, P and Pagidipati, NJ and Poulter, NR and Ramachandran, A and Reicher, B and Holman, RR and Hernandez, AF and EXSCEL, Study Group},
doi = {10.1161/JAHA.118.009304},
journal = {Journal of the American Heart Association},
title = {Effect of once-weekly exenatide on clinical outcomes according to baseline risk in patients with type 2 diabetes mellitus: Insights from the EXSCEL trial},
url = {http://dx.doi.org/10.1161/JAHA.118.009304},
volume = {7},
year = {2018}
}

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TY  - JOUR
AB  - Background In the EXSCEL (Exenatide Study of Cardiovascular Event Lowering), exenatide once-weekly resulted in a nonsignificant reduction in major adverse cardiovascular events ( MACEs ) and a nominal 14% reduction in all-cause mortality in 14 752 patients with type 2 diabetes mellitus (T2 DM ) with and without cardiovascular disease. Whether patients at increased risk for events experienced a comparatively greater treatment benefit with exenatide is unknown. Methods and Results In the EXSCEL population, we created risk scores for MACEs and all-cause mortality using step-wise selection of baseline characteristics. A risk score was calculated for each patient, and a time-to-event model for each end point was developed including the risk score, treatment assignment, and risk-treatment interaction. Interaction P values evaluating for a differential treatment effect by baseline risk were reported. Over a median follow-up of 3.2 years (interquartile range, 2.2, 4.4), 1091 (7.4%) patients died and 1744 (11.8%) experienced a MACE . Independent predictors of MACEs and all-cause mortality included age, sex, comorbidities (eg, previous cardiovascular event), body mass index, blood pressure, hemoglobin A1c, and estimated glomerular filtration rate. The all-cause mortality and MACE risk models had modest discrimination with optimism-corrected c-indices of 0.73 and 0.71, respectively. No interaction was observed between treatment effect and risk profile for either end point (both interactions, P>0.1). Conclusions Baseline characteristics (eg, age, previous cardiovascular events) and routine laboratory values (eg, hemoglobin A1c, estimated glomerular filtration rate) provided modest prognostic value for mortality and MACEs in a broad population of patients with type 2 diabetes mellitus. Exenatide's effects on mortality and MACEs were consistent across the spectrum of baseline risk. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: N
AU  - Mentz,RJ
AU  - Bethel,MA
AU  - Merrill,P
AU  - Lokhnygina,Y
AU  - Buse,JB
AU  - Chan,JC
AU  - Felício,JS
AU  - Goodman,SG
AU  - Choi,J
AU  - Gustavson,SM
AU  - Iqbal,N
AU  - Lopes,RD
AU  - Maggioni,AP
AU  - Öhman,P
AU  - Pagidipati,NJ
AU  - Poulter,NR
AU  - Ramachandran,A
AU  - Reicher,B
AU  - Holman,RR
AU  - Hernandez,AF
AU  - EXSCEL,Study Group
DO  - 10.1161/JAHA.118.009304
PY  - 2018///
SN  - 2047-9980
TI  - Effect of once-weekly exenatide on clinical outcomes according to baseline risk in patients with type 2 diabetes mellitus: Insights from the EXSCEL trial
T2  - Journal of the American Heart Association
UR  - http://dx.doi.org/10.1161/JAHA.118.009304
UR  - https://www.ncbi.nlm.nih.gov/pubmed/30371301
UR  - http://hdl.handle.net/10044/1/65163
VL  - 7
ER  -

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