PMID- 27179720
OWN - NLM
STAT- MEDLINE
DCOM- 20170517
LR  - 20191210
IS  - 1097-6744 (Electronic)
IS  - 0002-8703 (Linking)
VI  - 175
DP  - 2016 May
TI  - 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.
PG  - 18-27
LID - S0002-8703(16)00026-0 [pii]
LID - 10.1016/j.ahj.2016.01.011 [doi]
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.
CI  - Copyright (c) 2016 Elsevier Inc. All rights reserved.
FAU - Shimada, Yuichi J
AU  - Shimada YJ
AD  - Harvard Clinical Research Institute, Boston, MA; Cardiology Division, 
      Massachusetts General Hospital, Harvard Medical School, Boston, MA; 
      Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, 
      Harvard Medical School, Boston, MA. Electronic address: yshimada@partners.org.
FAU - Cannon, Christopher P
AU  - Cannon CP
AD  - Harvard Clinical Research Institute, Boston, MA; Cardiovascular Division, 
      Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, 
      Boston, MA.
FAU - Liu, Yuyin
AU  - Liu Y
AD  - Harvard Clinical Research Institute, Boston, MA; Department of Biostatistics, 
      Boston University, Boston, MA.
FAU - Wilson, Craig
AU  - Wilson C
AD  - Takeda Development Center Americas, Deerfield, IL.
FAU - Kupfer, Stuart
AU  - Kupfer S
AD  - Takeda Development Center Americas, Deerfield, IL.
FAU - Menon, Venu
AU  - Menon V
AD  - Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, 
      OH.
FAU - Cushman, William C
AU  - Cushman WC
AD  - University of Tennessee College of Medicine, Memphis Veterans Affairs Medical 
      Center, Memphis, TN.
FAU - Mehta, Cyrus R
AU  - Mehta CR
AD  - Harvard School of Public Health, Boston, MA.
FAU - Bakris, George L
AU  - Bakris GL
AD  - University of Chicago Medicine, Chicago, IL.
FAU - Zannad, Faeiz
AU  - Zannad F
AD  - Institut Lorrain du Coeur et des Vaisseaux, Centre d'Investigation Clinique 
      Inserm, Universite de Lorraine and CHU, Vandoeuvre-Les-Nancy, France.
FAU - White, William B
AU  - White WB
AD  - Calhoun Cardiology Center, University of Connecticut School of Medicine, 
      Farmington, CT.
CN  - EXAMINE Investigators
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20160123
PL  - United States
TA  - Am Heart J
JT  - American heart journal
JID - 0370465
RN  - 0 (Hypoglycemic Agents)
RN  - 0 (Piperidines)
RN  - 56HH86ZVCT (Uracil)
RN  - JHC049LO86 (alogliptin)
SB  - IM
MH  - *Acute Coronary Syndrome/complications/therapy
MH  - Aged
MH  - *Diabetes Mellitus, Type 2/complications/drug therapy
MH  - Female
MH  - Hospitalization/statistics & numerical data
MH  - Humans
MH  - Hypoglycemic Agents/administration & dosage/adverse effects
MH  - Male
MH  - Middle Aged
MH  - *Myocardial Infarction/epidemiology/etiology/therapy
MH  - *Myocardial Revascularization/methods/statistics & numerical data
MH  - Outcome and Process Assessment, Health Care
MH  - *Piperidines/administration & dosage/adverse effects
MH  - Risk Assessment
MH  - Standard of Care
MH  - *Stroke/epidemiology/etiology/therapy
MH  - Uracil/administration & dosage/adverse effects/*analogs & derivatives
EDAT- 2016/05/18 06:00
MHDA- 2017/05/18 06:00
CRDT- 2016/05/16 06:00
PHST- 2015/11/29 00:00 [received]
PHST- 2016/01/21 00:00 [accepted]
PHST- 2016/05/16 06:00 [entrez]
PHST- 2016/05/18 06:00 [pubmed]
PHST- 2017/05/18 06:00 [medline]
AID - S0002-8703(16)00026-0 [pii]
AID - 10.1016/j.ahj.2016.01.011 [doi]
PST - ppublish
SO  - Am Heart J. 2016 May;175:18-27. doi: 10.1016/j.ahj.2016.01.011. Epub 2016 Jan 23.