Evidence map›Paper›PMID 31542942›Full record

ArticleCirculation2019

Effect of Once-Weekly Exenatide in Patients With Type 2 Diabetes Mellitus With and Without Heart Failure and Heart Failure-Related Outcomes: Insights From the EXSCEL Trial.

Marat Fudim, Jennifer White, Neha J Pagidipati, Yuliya Lokhnygina, Julio Wainstein, Jan Murin, Nayyar Iqbal, Peter Öhman, Renato D Lopes, Barry Reicher and 3 more

Registry-linked trialAbstract readMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Circulation, 2019. 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 44 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 9 pooled it
6.2field-weighted citation impact, top 3% 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.

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

44 citing papers in PubMed, 9 syntheses or guidelines pooled it, 92 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 5 institutions in 6 countries.

Marat FudimDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).
Jennifer WhiteDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).
Neha J PagidipatiDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).
Yuliya LokhnyginaDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).
Julio WainsteinDiabetes Unit, The E. Wolfson Medical Center, Sackler Tel-Aviv University, Israel (J.W.).
Jan MurinUniversity Hospital, Bratislava, Slovakia (J.M.).
Nayyar IqbalAstraZeneca Research and Development, Gaithersburg, MD (N.I., P.Ö., B.R.).
Peter ÖhmanAstraZeneca Research and Development, Gaithersburg, MD (N.I., P.Ö., B.R.).
Renato D LopesDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).
Barry ReicherAstraZeneca Research and Development, Gaithersburg, MD (N.I., P.Ö., B.R.).
Rury R HolmanDiabetes Trials Unit, University of Oxford, United Kingdom (R.R.H.).
Adrian F HernandezDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).
Robert J MentzDuke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.F., J.W., N.J.P., Y.L., R.D.L., A.F.H., R.J.M.).
Clinical Research Institute · USAstraZeneca (Netherlands) · NLOxford Centre for Diabetes, Endocrinology and Metabolism · GBUniversity Hospital Bratislava · SKWolfson Medical Center · IL

Funding

MULTIDISCIPLINARY HEART &VASCULAR DISEASEST32HL007101 · NHLBI · DUKE UNIVERSITY · PI FREEDMAN, NEIL J. · 1985 to 2020
$9.8M
Dissemination and Implementation Science in Cardiovascular Outcomes (DISCO)K12HL138030 · NHLBI · DUKE UNIVERSITY · PI BOSWORTH, HAYDEN B · 2017 to 2021
$3.9M
NHLBI NIH HHS K12 HL138030NHLBI NIH HHS T32 HL007101
6 · The paper itself

Abstract

backgroundOnce-weekly exenatide (EQW) had a neutral effect on hospitalization for heart failure (HHF) in the EXSCEL study (Exenatide Study of Cardiovascular Event Lowering), with no differential treatment effect on major adverse cardiac events by baseline heart failure (HF) status. EQW's effects on secondary end points based on HHF status have not been reported. The objective was to explore the effects of EQW on secondary end points in patients with and without baseline HF and test the effects of EQW on recurrent HHF events.

methodsThe prespecified analysis of the randomized controlled EXSCEL trial, which enrolled patients with type 2 diabetes mellitus with and without additional cardiovascular disease, analyzed EQW effects on all-cause death, each major adverse cardiac event component, first HHF, and repeat HHF, by baseline HF status (regardless of ejection fraction). A subgroup analysis of the population stratified by preserved or reduced baseline ejection fraction was performed.

resultsOf 14 752 EXSCEL participants, 2389 (16.2%) had HF at baseline. Compared with those without HF at baseline, patients with preexisting HF were older, and more likely to be male and white, with a higher burden of other cardiovascular diseases. Overall, those assigned to EQW had a lower incidence of all-cause death (hazard ratio [HR], 0.86 [95% CI, 0.77-0.97]) and the composite outcome of all-cause death or HHF (HR, 0.89 [95% CI, 0.80-0.99]). When stratified by presence or absence of baseline HF, there was no observed reduction in all-cause death with EQW with baseline HF (HR, 1.05 [95% CI, 0.85-1.29]), while the risk of mortality was reduced with EQW in the no-HF group (HR, 0.79 [95% CI, 0.68-0.92]) with an interaction

conclusionsIn EXSCEL, the use of EQW in patients with or without HF was well tolerated, but benefits of EQW on reduction in all-cause death and first hospitalization for HF were attenuated in patients with baseline HF. CLINICAL

trial registrationhttps://www.clinicaltrials.gov. Unique identifier: NCT01144338.

Indexed as

AgedCause of DeathDiabetes Mellitus, Type 2Disease ProgressionDrug Administration ScheduleExenatideFemaleHeart FailureHumansHypoglycemic AgentsIncretinsMaleMiddle AgedPatient AdmissionRisk FactorsTime FactorsExenatideHypoglycemic AgentsIncretinsdiabetes mellitusexenatideheart failureoutcomes

Identifiers

PMID31542942
PMCPMC6924268
OpenAlexW2985002379

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.