Evidence map›Paper›PMID 28454792›Full record

Trial reportAmerican heart journal2017

Baseline characteristics of patients enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).

Robert J Mentz, M Angelyn Bethel, Stephanie Gustavson, Vivian P Thompson, Neha J Pagidipati, John B Buse, Juliana C Chan, Nayyar Iqbal, Aldo P Maggioni, Steve P Marso and 6 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American heart journal, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01144338 (Exenatide Study of Cardiovascular Event Lowering Trial), which is not on this map. Cited by 31 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 2 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.

NCT01144338 phase3completednot on this map

Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL). A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly in Patients With Type 2 Diabetes Mellitus.

TypeinterventionalSponsorAstraZenecaRan2010 to 2017Enrolled14,752ConditionsType 2 Diabetes MellitusArmsExenatide Once Weekly, Placebo
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 2 syntheses or guidelines pooled it.

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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

16 authors.

Robert J MentzDuke Clinical Research Institute, Durham, NC. Electronic address: robert.mentz@duke.edu.
M Angelyn BethelDiabetes Trials Unit, University of Oxford, Oxford, UK.
Stephanie GustavsonAstraZeneca Research and Development, Gaithersburg, MD.
Vivian P ThompsonDuke Clinical Research Institute, Durham, NC.
Neha J PagidipatiDuke Clinical Research Institute, Durham, NC.
John B BuseUniversity of North Carolina at Chapel Hill, Chapel Hill, NC.
Juliana C ChanThe Chinese University of Hong Kong, Hong Kong, SAR, China.
Nayyar IqbalAstraZeneca Research and Development, Gaithersburg, MD.
Aldo P MaggioniANMCO Research Centre, Florence, Italy.
Steve P MarsoUniversity of Texas Southwestern Medical Center, Dallas, TX.
Peter OhmanAstraZeneca Research and Development, Gaithersburg, MD.
Neil PoulterInternational Centre for Circulatory Health, NHLI, Imperial College London, London, UK.
Ambady RamachandranIndia Diabetes Research Foundation and Dr. A. Ramachandran's Diabetes Hospitals, Chennai, India.
Bernard ZinmanLunenfeld Tanenbaum Research Institute, Mount Sinai Hospital and University of Toronto, Toronto, Ontario, Canada.
Adrian F HernandezDuke Clinical Research Institute, Durham, NC.
Rury R HolmanDiabetes Trials Unit, University of Oxford, Oxford, UK.

Funding

Postdoctoral Training in Cardiovascular Clinical ResearchT32HL069749 · NHLBI · DUKE UNIVERSITY · PI Daniel B Mark · 2003 to 2023
$1.3M
NHLBI NIH HHS T32 HL069749NHLBI NIH HHS U10 HL110312NIA NIH HHS R01 AG045551
6 · The paper itself

Abstract

backgroundEXSCEL is a randomized, double-blind, placebo-controlled trial examining the effect of exenatide once-weekly (EQW) versus placebo on time to the primary composite outcome (cardiovascular death, nonfatal myocardial infarction or nonfatal stroke) in patients with type 2 diabetes mellitus (DM) and a wide range of cardiovascular (CV) risk.

methodsPatients were enrolled at 688 sites in 35 countries. We describe their baseline characteristics according to prior CV event status and compare patients with those enrolled in prior glucagon-like peptide-1 receptor agonist (GLP-1RA) outcomes trials.

resultsOf a total of 14,752 participants randomized between June 2010 and September 2015, 6,788 (46.0%) patients were enrolled in Europe; 3,708 (25.1%), North America; 2,727 (18.5%), Latin America; and 1,529 (10.4%), Asia Pacific. Overall, 73% had at least one prior CV event (70% coronary artery disease, 24% peripheral arterial disease, 22% cerebrovascular disease). The median (IQR) age was 63 years (56, 69), 38% were female, median baseline HbA1c was 8.0% (7.3, 8.9) and 16% had a prior history of heart failure. Those without a prior CV event were younger with a shorter duration of diabetes and better renal function than those with at least one prior CV event. Compared with prior GLP-1RA trials, EXSCEL has a larger percentage of patients without a prior CV event and a notable percentage who were taking a dipeptidyl peptidase-4 inhibitor at baseline (15%).

conclusionsEXSCEL is one of the largest global GLP-1RA trials, evaluating the safety and efficacy of EQW with a broad patient population that may extend generalizability compared to prior GLP-1RA trials (ClinicalTrials.gov number, NCT01144338).

Indexed as

AgedCardiovascular DiseasesDiabetes Mellitus, Type 2Double-Blind MethodExenatideFemaleGlucagon-Like Peptide-1 ReceptorHumansHypoglycemic AgentsMaleMiddle AgedMyocardial InfarctionPeptidesRisk FactorsStrokeVenomsExenatideGlucagon-Like Peptide-1 ReceptorHypoglycemic AgentsPeptidesVenoms

Identifiers

PMID28454792
PMCPMC9849915

What Socratic holds

Textmetadata
LicenceTDM
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.