Cardiovascular mortality in patients with type 2 diabetes and recent acute coronary syndromes from the EXAMINE trial

William B. White, Stuart Kupfer, Faiez Zannad, Cyrus R. Mehta, Craig A. Wilson, Lanyu Lei, George L. Bakris, Steven E. Nissen, William Cushman, Simon R. Heller, Richard M. Bergenstal, Penny R. Fleck, Christopher P. Cannon

Research output: Contribution to journalArticle

27 Citations (Scopus)

Abstract

Objective We evaluated the risk of cardiovascular (CV) death in all Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) study participants and in those who experienced an on-study, major nonfatal CV event. RESEARCH DESIGN AND METHODS The study randomly assigned 5,380 patients with type 2 diabetes to alogliptin or placebo within 15 to 90 days of an acute coronary syndrome (ACS). Deaths and nonfatal CV events (myocardial infarction [MI], stroke, hospitalized heart failure [HHF], and hospitalization for unstable angina [UA]) were adjudicated. Patients were monitored until censoring or death, regardless of a prior postrandomized nonfatal CV event. Time-updatedmultivariable Cox modelswere used to estimate the risk of death in the absence of or after each nonfatal event. RESULTS Rates of CV death were 4.1% for alogliptin and 4.9% for placebo (hazard ratio [HR] 0.85; 95%CI 0.66, 1.10). A total of 736 patients (13.7%) experienced a first nonfatal CV event (5.9% MI, 1.1% stroke, 3.0% HHF, and 3.8% UA). Compared with patients not experiencing a nonfatal event, the adjusted HR (95% CI) for death was 3.12 after MI (2.13, 4.58; P < 0.0001) 4.96 after HHF (3.29, 7.47; P < 0.0001), 3.08 after stroke (1.29, 7.37; P = 0.011), and 1.66 after UA (0.81, 3.37; P = 0.164). Mortality rates after a nonfatal event were comparable for alogliptin and placebo. CONCLUSIONS In patients with type 2 diabetes and a recent ACS, the risk of CV death was higher after a postrandomization, nonfatal CV event, particularly heart failure, compared with those who did not experience a CV event. The risk of CV death was similar between alogliptin and placebo.

Original languageEnglish (US)
Pages (from-to)1267-1273
Number of pages7
JournalDiabetes care
Volume39
Issue number7
DOIs
StatePublished - Jul 1 2016

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Acute Coronary Syndrome
Type 2 Diabetes Mellitus
Mortality
Unstable Angina
Heart Failure
Placebos
Stroke
Myocardial Infarction
Standard of Care
Hospitalization
alogliptin

All Science Journal Classification (ASJC) codes

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

Cite this

White, W. B., Kupfer, S., Zannad, F., Mehta, C. R., Wilson, C. A., Lei, L., ... Cannon, C. P. (2016). Cardiovascular mortality in patients with type 2 diabetes and recent acute coronary syndromes from the EXAMINE trial. Diabetes care, 39(7), 1267-1273. https://doi.org/10.2337/dc16-0303

Cardiovascular mortality in patients with type 2 diabetes and recent acute coronary syndromes from the EXAMINE trial. / White, William B.; Kupfer, Stuart; Zannad, Faiez; Mehta, Cyrus R.; Wilson, Craig A.; Lei, Lanyu; Bakris, George L.; Nissen, Steven E.; Cushman, William; Heller, Simon R.; Bergenstal, Richard M.; Fleck, Penny R.; Cannon, Christopher P.

In: Diabetes care, Vol. 39, No. 7, 01.07.2016, p. 1267-1273.

Research output: Contribution to journalArticle

White, WB, Kupfer, S, Zannad, F, Mehta, CR, Wilson, CA, Lei, L, Bakris, GL, Nissen, SE, Cushman, W, Heller, SR, Bergenstal, RM, Fleck, PR & Cannon, CP 2016, 'Cardiovascular mortality in patients with type 2 diabetes and recent acute coronary syndromes from the EXAMINE trial', Diabetes care, vol. 39, no. 7, pp. 1267-1273. https://doi.org/10.2337/dc16-0303
White, William B. ; Kupfer, Stuart ; Zannad, Faiez ; Mehta, Cyrus R. ; Wilson, Craig A. ; Lei, Lanyu ; Bakris, George L. ; Nissen, Steven E. ; Cushman, William ; Heller, Simon R. ; Bergenstal, Richard M. ; Fleck, Penny R. ; Cannon, Christopher P. / Cardiovascular mortality in patients with type 2 diabetes and recent acute coronary syndromes from the EXAMINE trial. In: Diabetes care. 2016 ; Vol. 39, No. 7. pp. 1267-1273.
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abstract = "Objective We evaluated the risk of cardiovascular (CV) death in all Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) study participants and in those who experienced an on-study, major nonfatal CV event. RESEARCH DESIGN AND METHODS The study randomly assigned 5,380 patients with type 2 diabetes to alogliptin or placebo within 15 to 90 days of an acute coronary syndrome (ACS). Deaths and nonfatal CV events (myocardial infarction [MI], stroke, hospitalized heart failure [HHF], and hospitalization for unstable angina [UA]) were adjudicated. Patients were monitored until censoring or death, regardless of a prior postrandomized nonfatal CV event. Time-updatedmultivariable Cox modelswere used to estimate the risk of death in the absence of or after each nonfatal event. RESULTS Rates of CV death were 4.1{\%} for alogliptin and 4.9{\%} for placebo (hazard ratio [HR] 0.85; 95{\%}CI 0.66, 1.10). A total of 736 patients (13.7{\%}) experienced a first nonfatal CV event (5.9{\%} MI, 1.1{\%} stroke, 3.0{\%} HHF, and 3.8{\%} UA). Compared with patients not experiencing a nonfatal event, the adjusted HR (95{\%} CI) for death was 3.12 after MI (2.13, 4.58; P < 0.0001) 4.96 after HHF (3.29, 7.47; P < 0.0001), 3.08 after stroke (1.29, 7.37; P = 0.011), and 1.66 after UA (0.81, 3.37; P = 0.164). Mortality rates after a nonfatal event were comparable for alogliptin and placebo. CONCLUSIONS In patients with type 2 diabetes and a recent ACS, the risk of CV death was higher after a postrandomization, nonfatal CV event, particularly heart failure, compared with those who did not experience a CV event. The risk of CV death was similar between alogliptin and placebo.",
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T1 - Cardiovascular mortality in patients with type 2 diabetes and recent acute coronary syndromes from the EXAMINE trial

AU - White, William B.

AU - Kupfer, Stuart

AU - Zannad, Faiez

AU - Mehta, Cyrus R.

AU - Wilson, Craig A.

AU - Lei, Lanyu

AU - Bakris, George L.

AU - Nissen, Steven E.

AU - Cushman, William

AU - Heller, Simon R.

AU - Bergenstal, Richard M.

AU - Fleck, Penny R.

AU - Cannon, Christopher P.

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N2 - Objective We evaluated the risk of cardiovascular (CV) death in all Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) study participants and in those who experienced an on-study, major nonfatal CV event. RESEARCH DESIGN AND METHODS The study randomly assigned 5,380 patients with type 2 diabetes to alogliptin or placebo within 15 to 90 days of an acute coronary syndrome (ACS). Deaths and nonfatal CV events (myocardial infarction [MI], stroke, hospitalized heart failure [HHF], and hospitalization for unstable angina [UA]) were adjudicated. Patients were monitored until censoring or death, regardless of a prior postrandomized nonfatal CV event. Time-updatedmultivariable Cox modelswere used to estimate the risk of death in the absence of or after each nonfatal event. RESULTS Rates of CV death were 4.1% for alogliptin and 4.9% for placebo (hazard ratio [HR] 0.85; 95%CI 0.66, 1.10). A total of 736 patients (13.7%) experienced a first nonfatal CV event (5.9% MI, 1.1% stroke, 3.0% HHF, and 3.8% UA). Compared with patients not experiencing a nonfatal event, the adjusted HR (95% CI) for death was 3.12 after MI (2.13, 4.58; P < 0.0001) 4.96 after HHF (3.29, 7.47; P < 0.0001), 3.08 after stroke (1.29, 7.37; P = 0.011), and 1.66 after UA (0.81, 3.37; P = 0.164). Mortality rates after a nonfatal event were comparable for alogliptin and placebo. CONCLUSIONS In patients with type 2 diabetes and a recent ACS, the risk of CV death was higher after a postrandomization, nonfatal CV event, particularly heart failure, compared with those who did not experience a CV event. The risk of CV death was similar between alogliptin and placebo.

AB - Objective We evaluated the risk of cardiovascular (CV) death in all Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care (EXAMINE) study participants and in those who experienced an on-study, major nonfatal CV event. RESEARCH DESIGN AND METHODS The study randomly assigned 5,380 patients with type 2 diabetes to alogliptin or placebo within 15 to 90 days of an acute coronary syndrome (ACS). Deaths and nonfatal CV events (myocardial infarction [MI], stroke, hospitalized heart failure [HHF], and hospitalization for unstable angina [UA]) were adjudicated. Patients were monitored until censoring or death, regardless of a prior postrandomized nonfatal CV event. Time-updatedmultivariable Cox modelswere used to estimate the risk of death in the absence of or after each nonfatal event. RESULTS Rates of CV death were 4.1% for alogliptin and 4.9% for placebo (hazard ratio [HR] 0.85; 95%CI 0.66, 1.10). A total of 736 patients (13.7%) experienced a first nonfatal CV event (5.9% MI, 1.1% stroke, 3.0% HHF, and 3.8% UA). Compared with patients not experiencing a nonfatal event, the adjusted HR (95% CI) for death was 3.12 after MI (2.13, 4.58; P < 0.0001) 4.96 after HHF (3.29, 7.47; P < 0.0001), 3.08 after stroke (1.29, 7.37; P = 0.011), and 1.66 after UA (0.81, 3.37; P = 0.164). Mortality rates after a nonfatal event were comparable for alogliptin and placebo. CONCLUSIONS In patients with type 2 diabetes and a recent ACS, the risk of CV death was higher after a postrandomization, nonfatal CV event, particularly heart failure, compared with those who did not experience a CV event. The risk of CV death was similar between alogliptin and placebo.

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