Evidence map›Paper›PMID 26630143›Full record

Trial reportThe New England journal of medicine2015

Lixisenatide in Patients with Type 2 Diabetes and Acute Coronary Syndrome.

Marc A Pfeffer, Brian Claggett, Rafael Diaz, Kenneth Dickstein, Hertzel C Gerstein, Lars V Køber, Francesca C Lawson, Lin Ping, Xiaodan Wei, Eldrin F Lewis and 7 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01147250 (A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome), which is not on this map. Cited by 978 papers, 39 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
978citing papers in PubMed, 39 pooled it
–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.

NCT01147250 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate Cardiovascular Outcomes During Treatment With Lixisenatide in Type 2 Diabetic Patients After an Acute Coronary Syndrome

TypeinterventionalSponsorSanofiRan2010 to 2015Enrolled6,068ConditionsAcute Coronary SyndromeArmsLixisenatide (AVE0010), Placebo
3 · Its place in the literature

Who cites it

978 citing papers in PubMed, 39 syntheses or guidelines pooled it.

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  11. The effect of GLP-1 receptor agonists on renal outcomes: a systematic review and meta-analysis.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2026
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918 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors.

Marc A PfefferFrom the Cardiovascular Division, Brigham and Women's Hospital, and Harvard Medical School - both in Boston (M.A.P., B.C., E.F.L., S.D.S.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); University of Bergen, Stavanger University Hospital, Stavanger, Norway (K.D.); McMaster University, Hamilton, ON, Canada (H.C.G.); Rigshospitalet Copenhagen University Hospital, Copenhagen (L.V.K.); Sanofi U.S., Bridgewater, NJ (F.C.L., L.P., X.W.); Research Center of the Italian Association of Hospital Cardiologists, Florence (A.P.M.); British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (J.J.V.M.); University of Washington Medical Center, Seattle (J.L.P.); Oregon Health and Science University, Portland (M.C.R.); and Montreal Heart Institute, Université de Montréal, Montreal (J.C.T.).
Brian Claggett
Rafael Diaz
Kenneth Dickstein
Hertzel C Gerstein
Lars V Køber
Francesca C Lawson
Lin Ping
Xiaodan Wei
Eldrin F Lewis
Aldo P Maggioni
John J V McMurray
Jeffrey L Probstfield
Matthew C Riddle
Scott D Solomon
Jean-Claude Tardif
ELIXA Investigators

Funding

LCenter for Clinical and Translational Science and TrainingUL1TR001425 · NCATS · UNIVERSITY OF CINCINNATI · PI MEINZEN-DERR, JAREEN, STRAWN, JEFFREY ROBERT · 2015 to 2024
$37.5M
6 · The paper itself

Abstract

backgroundCardiovascular morbidity and mortality are higher among patients with type 2 diabetes, particularly those with concomitant cardiovascular diseases, than in most other populations. We assessed the effects of lixisenatide, a glucagon-like peptide 1-receptor agonist, on cardiovascular outcomes in patients with type 2 diabetes who had had a recent acute coronary event.

methodsWe randomly assigned patients with type 2 diabetes who had had a myocardial infarction or who had been hospitalized for unstable angina within the previous 180 days to receive lixisenatide or placebo in addition to locally determined standards of care. The trial was designed with adequate statistical power to assess whether lixisenatide was noninferior as well as superior to placebo, as defined by an upper boundary of the 95% confidence interval for the hazard ratio of less than 1.3 and 1.0, respectively, for the primary composite end point of cardiovascular death, myocardial infarction, stroke, or hospitalization for unstable angina.

resultsThe 6068 patients who underwent randomization were followed for a median of 25 months. A primary end-point event occurred in 406 patients (13.4%) in the lixisenatide group and in 399 (13.2%) in the placebo group (hazard ratio, 1.02; 95% confidence interval [CI], 0.89 to 1.17), which showed the noninferiority of lixisenatide to placebo (P<0.001) but did not show superiority (P=0.81). There were no significant between-group differences in the rate of hospitalization for heart failure (hazard ratio in the lixisenatide group, 0.96; 95% CI, 0.75 to 1.23) or the rate of death (hazard ratio, 0.94; 95% CI, 0.78 to 1.13). Lixisenatide was not associated with a higher rate of serious adverse events or severe hypoglycemia, pancreatitis, pancreatic neoplasms, or allergic reactions than was placebo.

conclusionsIn patients with type 2 diabetes and a recent acute coronary syndrome, the addition of lixisenatide to usual care did not significantly alter the rate of major cardiovascular events or other serious adverse events. (Funded by Sanofi; ELIXA ClinicalTrials.gov number, NCT01147250.).

Indexed as

Glucagon-Like Peptide-1 Receptor AgonistsAcute Coronary SyndromeAgedAngina, UnstableCardiovascular DiseasesDiabetes Mellitus, Type 2FemaleGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHumansHypoglycemic AgentsKaplan-Meier EstimateMaleMiddle AgedMyocardial InfarctionPeptidesGlucagon-Like Peptide-1 Receptor AgonistsGlucagon-Like Peptide-2 ReceptorGlycated HemoglobinHypoglycemic AgentslixisenatidePeptides

Identifiers

PMID26630143

What OpenQuestion holds

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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.