Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.

dc.contributor.author

Holman, Rury R

dc.contributor.author

Bethel, M Angelyn

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Mentz, Robert J

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Thompson, Vivian P

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Lokhnygina, Yuliya

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Buse, John B

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Chan, Juliana C

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Choi, Jasmine

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Gustavson, Stephanie M

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Iqbal, Nayyar

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Maggioni, Aldo P

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Marso, Steven P

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Öhman, Peter

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Pagidipati, Neha J

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Poulter, Neil

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Ramachandran, Ambady

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Zinman, Bernard

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Hernandez, Adrian F

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EXSCEL Study Group

dc.date.accessioned

2024-04-01T13:42:09Z

dc.date.available

2024-04-01T13:42:09Z

dc.date.issued

2017-09

dc.description.abstract

Background

The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown.

Methods

We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy.

Results

In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority). The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome, and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups.

Conclusions

Among patients with type 2 diabetes with or without previous cardiovascular disease, the incidence of major adverse cardiovascular events did not differ significantly between patients who received exenatide and those who received placebo. (Funded by Amylin Pharmaceuticals; EXSCEL ClinicalTrials.gov number, NCT01144338 .).
dc.identifier.issn

0028-4793

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1533-4406

dc.identifier.uri

https://hdl.handle.net/10161/30420

dc.language

eng

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Massachusetts Medical Society

dc.relation.ispartof

The New England journal of medicine

dc.relation.isversionof

10.1056/nejmoa1612917

dc.rights.uri

https://creativecommons.org/licenses/by-nc/4.0

dc.subject

EXSCEL Study Group

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Venoms

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Humans

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Cardiovascular Diseases

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Diabetes Mellitus, Type 2

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Peptides

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Hypoglycemic Agents

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Injections, Subcutaneous

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Drug Administration Schedule

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Incidence

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Least-Squares Analysis

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Double-Blind Method

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Aged

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Middle Aged

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Female

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Male

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Kaplan-Meier Estimate

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Exenatide

dc.title

Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.

dc.type

Journal article

duke.contributor.orcid

Mentz, Robert J|0000-0002-3222-1719

duke.contributor.orcid

Hernandez, Adrian F|0000-0003-3387-9616

pubs.begin-page

1228

pubs.end-page

1239

pubs.issue

13

pubs.organisational-group

Duke

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School of Medicine

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Basic Science Departments

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Clinical Science Departments

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Institutes and Centers

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Biostatistics & Bioinformatics

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Medicine

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Medicine, Cardiology

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Medicine, Endocrinology, Metabolism, and Nutrition

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Duke Clinical Research Institute

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University Initiatives & Academic Support Units

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Neurology

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Neurology, Neurocritical Care

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Initiatives

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Neurosurgery

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Population Health Sciences

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Duke - Margolis Center For Health Policy

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Biostatistics & Bioinformatics, Division of Biostatistics

pubs.publication-status

Published

pubs.volume

377

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