Evidence map›Paper›PMID 32493335›Full record

Trial reportBMC medicine2020

Alogliptin after acute coronary syndrome in patients with type 2 diabetes: a renal function stratified analysis of the EXAMINE trial.

João Pedro Ferreira, Cyrus Mehta, Abhinav Sharma, Steven E Nissen, Patrick Rossignol, Faiez Zannad

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC medicine, 2020. 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 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
1.8field-weighted citation impact, top 13% 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.

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

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 24 citations in OpenAlex.

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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

6 authors at 6 institutions in 3 countries.

João Pedro FerreiraUniversité de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France, CHRU de Nancy, Inserm U1116, Nancy, France, FCRIN INI-CRCT, Nancy, France. j.ferreira@chru-nancy.fr.
Cyrus MehtaCytel Corportation, Cambridge, MA, USA.
Abhinav SharmaDivision of Cardiology, McGill University Health Centre, McGill University, Montreal, Quebec, Canada.
Steven E NissenCleveland Clinic Coordinating Center for Clinical Research, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA.
Patrick RossignolUniversité de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France, CHRU de Nancy, Inserm U1116, Nancy, France, FCRIN INI-CRCT, Nancy, France.
Faiez ZannadUniversité de Lorraine, Centre d'Investigations Cliniques Plurithématique Inserm 1433, Nancy, France, CHRU de Nancy, Inserm U1116, Nancy, France, FCRIN INI-CRCT, Nancy, France.
Center for Clinical Research (United States) · USCentre d'Investigation Clinique Pierre Drouin · FRCytel (United States) · USDéfaillance Cardiovasculaire Aiguë et ChroniqueFrench Clinical Research Infrastructure Network · FRMcGill University Health Centre · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe EXAMINE trial tested the efficacy and safety of alogliptin, an inhibitor of dipeptidyl peptidase 4, compared with placebo in 5380 patients with type 2 diabetes and a recent acute coronary syndrome. Because alogliptin is cleared by the kidney, patients were stratified according to screening renal function within two independently randomized strata: (1) estimated glomerular filtration rate (eGFR) ≥ 60 ml/min/1.73m

methodsCox-proportional hazard models with an interaction term by renal function strata were used. The primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction (MI), or nonfatal stroke.

resultsPatient characteristics were balanced within each renal function strata. In total, 3946 patients were randomized within the eGFR ≥ 60 stratum, and 1434 patients within the eGFR < 60 stratum. The effect of alogliptin was modified by the renal function strata. PRIMARY OUTCOME: eGFR ≥ 60 HR = 0.81, 95%CI, 0.65-0.99, and eGFR < 60 HR = 1.20, 95%CI, 0.95-1.53; interaction

conclusionsAlogliptin may benefit patients with eGFR ≥ 60, but may be detrimental to patients with eGFR < 60 ml/min/1.73m

trial registrationClinicalTrials.gov, NCT00968708.

Indexed as

Acute Coronary SyndromeDiabetes Mellitus, Type 2FemaleHumansHypoglycemic AgentsKidneyMaleMiddle AgedPiperidinesTreatment OutcomeUracilalogliptinHypoglycemic AgentsPiperidinesUracilAlogliptinOutcomesRenal functionStratification

Identifiers

PMID32493335
PMCPMC7271537
OpenAlexW3030553177

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.