Evidence map›Paper›PMID 29064626›Full record

Trial reportDiabetes, obesity & metabolism2018

High-sensitivity C-reactive protein, low-density lipoprotein cholesterol and cardiovascular outcomes in patients with type 2 diabetes in the EXAMINE (Examination of Cardiovascular Outcomes with Alogliptin versus Standard of Care) trial.

You-Cheol Hwang, David A Morrow, Christopher P Cannon, Yuyin Liu, Richard Bergenstal, Simon Heller, Cyrus Mehta, William Cushman, George L Bakris, Faiez Zannad and 1 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00968708 (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), which is not on this map. Cited by 25 papers.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed
–field-weighted citation impact
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.

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

25 citing papers in PubMed.

  1. Influence of sex, age and race on coronary and heart failure events in patients with diabetes and post-acute coronary syndrome.Clinical research in cardiology : official journal of the German Cardiac Society · 2021
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  15. The IL-1 Family and Its Role in Atherosclerosis.International journal of molecular sciences · 2022
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

You-Cheol HwangDivision of Endocrinology and Metabolism, Department of Medicine, Kyung Hee University School of Medicine, Kyung Hee University Hospital at Gangdong, Seoul, South Korea.
David A MorrowCardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.
Christopher P CannonBaim Institute for Clinical Research, Boston, Massachusetts.
Yuyin LiuBaim Institute for Clinical Research, Boston, Massachusetts.
Richard BergenstalInternational Diabetes Center, Park-Nicollet Clinic, Minneapolis, Minnesota.
Simon HellerUniversity of Sheffield, Sheffield, UK.ORCID 0000-0002-2425-9565
Cyrus MehtaHarvard School of Public Health, Boston, Massachusetts.
William CushmanUniversity of Tennessee College of Medicine, Memphis, Tennessee.
George L BakrisUniversity of Chicago Med, Chicago, Illinois.
Faiez ZannadUniversite de Lorraine, Nancy, France.
William B WhiteUniversity of Connecticut School of Medicine, Farmington, Connecticut.ORCID 0000-0001-8936-967X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsWe sought to assess the risk of major adverse cardiovascular events (MACE) by utilizing high-sensitivity C-reactive protein (hsCRP) level and low-density lipoprotein cholesterol (LDL-C) in patients with type 2 diabetes and recent acute coronary syndrome. MATERIALS AND

methodsStudy participants enrolled in the EXAMINE trial (Clinical trials registration number: NCT00968708) and were stratified by baseline hsCRP levels (<1, 1-3 and >3 mg/L). They were also sub-divided into 4 groups according to baseline hsCRP (≤3 or >3 mg/L) and achieved LDL-C (<70 or ≥70 mg/dL) levels. Among 5380 patients, the MACE rate, a composite of cardiovascular death, non-fatal acute myocardial infarction and non-fatal stroke, was evaluated during the 30 months of follow-up.

resultsCumulative incidence of MACE was 11.5% (119 events), 14.6% (209 events) and 18.4% (287 events) in patients with hsCRP levels of <1, 1 to 3 and >3 mg/L, respectively (P < .001). In patients with hsCRP >3 mg/L, the adjusted hazard ratio (95% confidence interval) was 1.42 (1.13, 1.78; P = .002) for MACE compared with patients with hsCRP <1 mg/L. MACE cumulative incidences were 11.0% (128 events), 14.4% (100 events), 15.6% (194 events) and 21.3% (182 events) in patients with low LDL-C and low hsCRP, low LDL-C and high hsCRP, high LDL-C and low hsCRP, and high LDL-C and high hsCRP levels, respectively (P < .001).

conclusionsLevels of hsCRP were associated with recurrent cardiovascular events in patients with type 2 diabetes and recent acute coronary syndrome, and this association appears to be independent of and additive to the achieved LDL-C level.

Indexed as

Acute Coronary SyndromeCholesterol, LDLC-Reactive ProteinDiabetes Mellitus, Type 2Diabetic AngiopathiesDouble-Blind MethodFemaleHeart FailureHumansHypoglycemic AgentsMaleMiddle AgedMyocardial InfarctionMyocardial RevascularizationPiperidinesStandard of CarealogliptinCholesterol, LDLC-Reactive ProteinHypoglycemic AgentsPiperidinesUracilacute coronary syndromescardiovascular outcomeshigh-sensitivity C-reactive proteinLDL cholesteroltype 2 diabetes

Identifiers

PMID29064626
PMCPMC5836896

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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 OpenQuestion graph.