Evidence map›Paper›PMID 30371301›Full record

Trial reportJournal of the American Heart Association2018

Effect of Once-Weekly Exenatide on Clinical Outcomes According to Baseline Risk in Patients With Type 2 Diabetes Mellitus: Insights From the EXSCEL Trial.

Robert J Mentz, M Angelyn Bethel, Peter Merrill, Yuliya Lokhnygina, John B Buse, Juliana C Chan, João S Felício, Shaun G Goodman, Jasmine Choi, Stephanie M Gustavson and 11 more

Open access · goldAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of the American Heart Association, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 3 pooled it
2.3field-weighted citation impact, top 11% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 3 syntheses or guidelines pooled it, 30 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

21 authors at 11 institutions in 6 countries.

Robert J Mentz1 Duke Clinical Research Institute Duke University School of Medicine Durham NC.
M Angelyn Bethel2 Diabetes Trials Unit Oxford Centre for Diabetes, Endocrinology and Metabolism University of Oxford United Kingdom.
Peter Merrill1 Duke Clinical Research Institute Duke University School of Medicine Durham NC.
Yuliya Lokhnygina1 Duke Clinical Research Institute Duke University School of Medicine Durham NC.
John B Buse3 Department of Medicine University of North Carolina School of Medicine Chapel Hill NC.
Juliana C Chan4 Department of Medicine & Therapeutics The Chinese University of Hong Kong China.
João S Felício5 Hospital Universitário João de Barros Barreto-UFPA Belém Brazil.
Shaun G Goodman6 St. Michael's Hospital University of Toronto Ontario Canada.
Jasmine Choi8 AstraZeneca Research and Development Gaithersburg MD.
Stephanie M Gustavson8 AstraZeneca Research and Development Gaithersburg MD.
Nayyar Iqbal8 AstraZeneca Research and Development Gaithersburg MD.
Renato D Lopes1 Duke Clinical Research Institute Duke University School of Medicine Durham NC.
Aldo P Maggioni9 ANMCO Research Center Firenze Italy.
Peter Öhman8 AstraZeneca Research and Development Gaithersburg MD.
Neha J Pagidipati1 Duke Clinical Research Institute Duke University School of Medicine Durham NC.
Neil R Poulter10 International Centre for Circulatory Health Imperial College London United Kingdom.
Ambady Ramachandran11 India Diabetes Research Foundation and Dr. A. Ramachandran's Diabetes Hospitals Chennai India.
Barry Reicher8 AstraZeneca Research and Development Gaithersburg MD.
Rury R Holman2 Diabetes Trials Unit Oxford Centre for Diabetes, Endocrinology and Metabolism University of Oxford United Kingdom.
Adrian F Hernandez1 Duke Clinical Research Institute Duke University School of Medicine Durham NC.
EXSCEL Study Group
AstraZeneca (United States) · USClinical Research Institute · USDuke University · USAssociazione Nazionale Medici Cardiologi Ospedalieri · ITChinese University of Hong Kong · CNDr. A. Ramachandran's Diabetes Hospitals · INImperial College London · GBOxford Centre for Diabetes, Endocrinology and Metabolism · GBUniversity of North Carolina at Chapel Hill · USUniversity of Oxford · GBUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background In the EXSCEL (Exenatide Study of Cardiovascular Event Lowering), exenatide once-weekly resulted in a nonsignificant reduction in major adverse cardiovascular events ( MACEs ) and a nominal 14% reduction in all-cause mortality in 14 752 patients with type 2 diabetes mellitus (T2 DM ) with and without cardiovascular disease. Whether patients at increased risk for events experienced a comparatively greater treatment benefit with exenatide is unknown. Methods and Results In the EXSCEL population, we created risk scores for MACEs and all-cause mortality using step-wise selection of baseline characteristics. A risk score was calculated for each patient, and a time-to-event model for each end point was developed including the risk score, treatment assignment, and risk-treatment interaction. Interaction P values evaluating for a differential treatment effect by baseline risk were reported. Over a median follow-up of 3.2 years (interquartile range, 2.2, 4.4), 1091 (7.4%) patients died and 1744 (11.8%) experienced a MACE . Independent predictors of MACEs and all-cause mortality included age, sex, comorbidities (eg, previous cardiovascular event), body mass index, blood pressure, hemoglobin A1c, and estimated glomerular filtration rate. The all-cause mortality and MACE risk models had modest discrimination with optimism-corrected c-indices of 0.73 and 0.71, respectively. No interaction was observed between treatment effect and risk profile for either end point (both interactions, P>0.1). Conclusions Baseline characteristics (eg, age, previous cardiovascular events) and routine laboratory values (eg, hemoglobin A1c, estimated glomerular filtration rate) provided modest prognostic value for mortality and MACEs in a broad population of patients with type 2 diabetes mellitus. Exenatide's effects on mortality and MACEs were consistent across the spectrum of baseline risk. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT 01144338.

Indexed as

AgedCardiovascular DiseasesCause of DeathDiabetes Mellitus, Type 2Dose-Response Relationship, DrugDrug Administration ScheduleExenatideFemaleFollow-Up StudiesGlycated HemoglobinHumansHypoglycemic AgentsIncidenceMaleMiddle AgedRetrospective StudiesExenatideGlycated Hemoglobinhemoglobin A1c protein, humanHypoglycemic Agentsglucagon‐like peptide‐1 receptor agonismajor adverse cardiac eventmortalitytype 2 diabetes mellitus

Identifiers

PMID30371301
PMCPMC6404902
OpenAlexW2890741038

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.