Evidence map›Paper›PMID 23992602›Full record

Trial reportThe New England journal of medicine2013

Alogliptin after acute coronary syndrome in patients with type 2 diabetes.

William B White, Christopher P Cannon, Simon R Heller, Steven E Nissen, Richard M Bergenstal, George L Bakris, Alfonso T Perez, Penny R Fleck, Cyrus R Mehta, Stuart Kupfer and 4 more

2 registry-linked trialsOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 942 papers, 26 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
942citing papers in PubMed, 26 pooled it
173.0field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06286878 phase2 / phase3recruitingstarted 2021, after this paper: background citation

Pleiotropic Effects of Dapagliflozin in Patients With Acute Coronary Syndromes

Ran2021Enrolled80Registered outcomes4Posted comparisons0ConditionsAcute Coronary Syndrome, Diabetes, Myocardial Infarction, Ventricular DysfunctionArmsdapagliflozin, Placebo
PMID 14502100PMID 28605608PMID 21205121PMID 26026848PMID 27295427PMID 28522450PMID 11602624PMID 30424892PMID 11179406PMID 11595605PMID 16046311PMID 17852797other papers from this trial
Open the trial in the graph
NCT00968708 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Cardiovascular Outcomes Following Treatment With Alogliptin in Addition to Standard of Care in Subjects With Type 2 Diabetes and Acute Coronary Syndrome

TypeinterventionalSponsorTakedaRan2009 to 2013Enrolled5,380ConditionsDiabetes Mellitus, Type 2, Acute Coronary SyndromeArmsAlogliptin, Placebo
3 · Its place in the literature

Who cites it

942 citing papers in PubMed, 26 syntheses or guidelines pooled it, 2,508 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Pooled it
  10. Pooled it
  11. Pooled it
  12. Pooled it
  13. Pooled it
  14. Guideline
  15. Pooled it
  16. Pooled it
  17. Pooled it
  18. Pooled it
  19. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  20. Pooled it

882 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 10 institutions in 3 countries.

William B WhiteCalhoun Cardiology Center, Department of Medicine, University of Connecticut School of Medicine, 263 Farmington Ave., Farmington, CT 06030-3940, USA. wwhite@nso1.uchc.edu
Christopher P Cannon
Simon R Heller
Steven E Nissen
Richard M Bergenstal
George L Bakris
Alfonso T Perez
Penny R Fleck
Cyrus R Mehta
Stuart Kupfer
Craig Wilson
William C Cushman
Faiez Zannad
EXAMINE Investigators
Deerfield (United States) · USHarvard University · USTakeda (United States) · USCleveland Clinic · USPark Nicollet Clinic · USUniversité de Lorraine · FRUniversity of Chicago · USUniversity of Connecticut · USUniversity of Sheffield · GBUniversity of Tennessee at Knoxville · US

Funding

NCATS NIH HHS UL1 TR000041
6 · The paper itself

Abstract

backgroundTo assess potentially elevated cardiovascular risk related to new antihyperglycemic drugs in patients with type 2 diabetes, regulatory agencies require a comprehensive evaluation of the cardiovascular safety profile of new antidiabetic therapies. We assessed cardiovascular outcomes with alogliptin, a new inhibitor of dipeptidyl peptidase 4 (DPP-4), as compared with placebo in patients with type 2 diabetes who had had a recent acute coronary syndrome.

methodsWe randomly assigned patients with type 2 diabetes and either an acute myocardial infarction or unstable angina requiring hospitalization within the previous 15 to 90 days to receive alogliptin or placebo in addition to existing antihyperglycemic and cardiovascular drug therapy. The study design was a double-blind, noninferiority trial with a prespecified noninferiority margin of 1.3 for the hazard ratio for the primary end point of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.

resultsA total of 5380 patients underwent randomization and were followed for up to 40 months (median, 18 months). A primary end-point event occurred in 305 patients assigned to alogliptin (11.3%) and in 316 patients assigned to placebo (11.8%) (hazard ratio, 0.96; upper boundary of the one-sided repeated confidence interval, 1.16; P<0.001 for noninferiority). Glycated hemoglobin levels were significantly lower with alogliptin than with placebo (mean difference, -0.36 percentage points; P<0.001). Incidences of hypoglycemia, cancer, pancreatitis, and initiation of dialysis were similar with alogliptin and placebo.

conclusionsAmong patients with type 2 diabetes who had had a recent acute coronary syndrome, the rates of major adverse cardiovascular events were not increased with the DPP-4 inhibitor alogliptin as compared with placebo. (Funded by Takeda Development Center Americas; EXAMINE ClinicalTrials.gov number, NCT00968708.).

Indexed as

AgedAngina, UnstableCardiovascular DiseasesDiabetes Mellitus, Type 2Dipeptidyl-Peptidase IV InhibitorsDouble-Blind MethodFemaleGlycated HemoglobinHumansHypoglycemic AgentsMaleMiddle AgedMyocardial InfarctionPiperidinesUracilalogliptinDipeptidyl-Peptidase IV InhibitorsGlycated HemoglobinHypoglycemic AgentsPiperidinesUracil

Identifiers

PMID23992602
OpenAlexW2127854619

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.