Ischemic cardiac outcomes and hospitalizations according to prior macrovascular disease status in patients with type 2 diabetes and recent acute coronary syndrome from the Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care trial

EXAMINE Investigators

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

Background: Concerns raised regarding adverse cardiovascular (CV) outcomes with new therapies for type 2 diabetes mellitus (T2DM) have led to several large-scale CV outcome trials. The EXAMINE trial confirmed noninferiority of the dipeptidyl dipeptidase 4 inhibitor alogliptin to placebo on major adverse cardiac event rates in a post-acute coronary syndrome (ACS) T2DM population. We present data on additional ischemic cardiac events and CV hospitalizations in EXAMINE. Methods: Patients with T2DM and an ACS event in the previous 15 to 90 days were randomly assigned to alogliptin or placebo on a background of standard treatment for diabetes. The incident rates of a 5-component composite end point of CV death, stroke, myocardial infarction, unstable angina, and coronary revascularization as well as CV hospitalization were calculated in all participants and according to macrovascular disease at baseline. Results: There were no significant differences between alogliptin (n = 2,701) and placebo (n = 2,679) in the event rate of the 5-component composite endpoint with median follow-up 533 days (21.0% vs 21.5%, hazard ratio [HR] 0.98 [0.87-1.10], P =.72). No differences were observed in terms of CV hospitalization (25.0% vs 25.4%, HR 0.98 [0.88-1.09], P =.70) or coronary revascularization (10.6% vs 10.2%, HR 1.05 [0.88-1.09], P =.60). No interactions were observed for treatment and prior macrovascular disease. Conclusions: EXAMINE demonstrates that there was no increase in the risk of cardiac ischemic events and CV hospitalizations with alogliptin in a high-risk post-ACS patient population. Because these are major driver of overall health care costs, these data suggest that there would be no adverse impact on health care resource utilization.

Original languageEnglish (US)
Pages (from-to)18-27
Number of pages10
JournalAmerican Heart Journal
Volume175
DOIs
StatePublished - May 1 2016

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Standard of Care
Acute Coronary Syndrome
Type 2 Diabetes Mellitus
Hospitalization
Placebos
Myocardial Infarction
Patient Acceptance of Health Care
Health Resources
Unstable Angina
Health Care Costs
Population
Therapeutics
alogliptin

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

@article{dd3a590e1437466fa509a7133d1b2262,
title = "Ischemic cardiac outcomes and hospitalizations according to prior macrovascular disease status in patients with type 2 diabetes and recent acute coronary syndrome from the Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care trial",
abstract = "Background: Concerns raised regarding adverse cardiovascular (CV) outcomes with new therapies for type 2 diabetes mellitus (T2DM) have led to several large-scale CV outcome trials. The EXAMINE trial confirmed noninferiority of the dipeptidyl dipeptidase 4 inhibitor alogliptin to placebo on major adverse cardiac event rates in a post-acute coronary syndrome (ACS) T2DM population. We present data on additional ischemic cardiac events and CV hospitalizations in EXAMINE. Methods: Patients with T2DM and an ACS event in the previous 15 to 90 days were randomly assigned to alogliptin or placebo on a background of standard treatment for diabetes. The incident rates of a 5-component composite end point of CV death, stroke, myocardial infarction, unstable angina, and coronary revascularization as well as CV hospitalization were calculated in all participants and according to macrovascular disease at baseline. Results: There were no significant differences between alogliptin (n = 2,701) and placebo (n = 2,679) in the event rate of the 5-component composite endpoint with median follow-up 533 days (21.0{\%} vs 21.5{\%}, hazard ratio [HR] 0.98 [0.87-1.10], P =.72). No differences were observed in terms of CV hospitalization (25.0{\%} vs 25.4{\%}, HR 0.98 [0.88-1.09], P =.70) or coronary revascularization (10.6{\%} vs 10.2{\%}, HR 1.05 [0.88-1.09], P =.60). No interactions were observed for treatment and prior macrovascular disease. Conclusions: EXAMINE demonstrates that there was no increase in the risk of cardiac ischemic events and CV hospitalizations with alogliptin in a high-risk post-ACS patient population. Because these are major driver of overall health care costs, these data suggest that there would be no adverse impact on health care resource utilization.",
author = "{EXAMINE Investigators} and Shimada, {Yuichi J.} and Cannon, {Christopher P.} and Yuyin Liu and Craig Wilson and Stuart Kupfer and Venu Menon and William Cushman and Mehta, {Cyrus R.} and Bakris, {George L.} and Faeiz Zannad and White, {William B.}",
year = "2016",
month = "5",
day = "1",
doi = "10.1016/j.ahj.2016.01.011",
language = "English (US)",
volume = "175",
pages = "18--27",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby Inc.",

}

TY - JOUR

T1 - Ischemic cardiac outcomes and hospitalizations according to prior macrovascular disease status in patients with type 2 diabetes and recent acute coronary syndrome from the Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care trial

AU - EXAMINE Investigators

AU - Shimada, Yuichi J.

AU - Cannon, Christopher P.

AU - Liu, Yuyin

AU - Wilson, Craig

AU - Kupfer, Stuart

AU - Menon, Venu

AU - Cushman, William

AU - Mehta, Cyrus R.

AU - Bakris, George L.

AU - Zannad, Faeiz

AU - White, William B.

PY - 2016/5/1

Y1 - 2016/5/1

N2 - Background: Concerns raised regarding adverse cardiovascular (CV) outcomes with new therapies for type 2 diabetes mellitus (T2DM) have led to several large-scale CV outcome trials. The EXAMINE trial confirmed noninferiority of the dipeptidyl dipeptidase 4 inhibitor alogliptin to placebo on major adverse cardiac event rates in a post-acute coronary syndrome (ACS) T2DM population. We present data on additional ischemic cardiac events and CV hospitalizations in EXAMINE. Methods: Patients with T2DM and an ACS event in the previous 15 to 90 days were randomly assigned to alogliptin or placebo on a background of standard treatment for diabetes. The incident rates of a 5-component composite end point of CV death, stroke, myocardial infarction, unstable angina, and coronary revascularization as well as CV hospitalization were calculated in all participants and according to macrovascular disease at baseline. Results: There were no significant differences between alogliptin (n = 2,701) and placebo (n = 2,679) in the event rate of the 5-component composite endpoint with median follow-up 533 days (21.0% vs 21.5%, hazard ratio [HR] 0.98 [0.87-1.10], P =.72). No differences were observed in terms of CV hospitalization (25.0% vs 25.4%, HR 0.98 [0.88-1.09], P =.70) or coronary revascularization (10.6% vs 10.2%, HR 1.05 [0.88-1.09], P =.60). No interactions were observed for treatment and prior macrovascular disease. Conclusions: EXAMINE demonstrates that there was no increase in the risk of cardiac ischemic events and CV hospitalizations with alogliptin in a high-risk post-ACS patient population. Because these are major driver of overall health care costs, these data suggest that there would be no adverse impact on health care resource utilization.

AB - Background: Concerns raised regarding adverse cardiovascular (CV) outcomes with new therapies for type 2 diabetes mellitus (T2DM) have led to several large-scale CV outcome trials. The EXAMINE trial confirmed noninferiority of the dipeptidyl dipeptidase 4 inhibitor alogliptin to placebo on major adverse cardiac event rates in a post-acute coronary syndrome (ACS) T2DM population. We present data on additional ischemic cardiac events and CV hospitalizations in EXAMINE. Methods: Patients with T2DM and an ACS event in the previous 15 to 90 days were randomly assigned to alogliptin or placebo on a background of standard treatment for diabetes. The incident rates of a 5-component composite end point of CV death, stroke, myocardial infarction, unstable angina, and coronary revascularization as well as CV hospitalization were calculated in all participants and according to macrovascular disease at baseline. Results: There were no significant differences between alogliptin (n = 2,701) and placebo (n = 2,679) in the event rate of the 5-component composite endpoint with median follow-up 533 days (21.0% vs 21.5%, hazard ratio [HR] 0.98 [0.87-1.10], P =.72). No differences were observed in terms of CV hospitalization (25.0% vs 25.4%, HR 0.98 [0.88-1.09], P =.70) or coronary revascularization (10.6% vs 10.2%, HR 1.05 [0.88-1.09], P =.60). No interactions were observed for treatment and prior macrovascular disease. Conclusions: EXAMINE demonstrates that there was no increase in the risk of cardiac ischemic events and CV hospitalizations with alogliptin in a high-risk post-ACS patient population. Because these are major driver of overall health care costs, these data suggest that there would be no adverse impact on health care resource utilization.

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U2 - 10.1016/j.ahj.2016.01.011

DO - 10.1016/j.ahj.2016.01.011

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AN - SCOPUS:84960192810

VL - 175

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JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

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