Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo

ELIXA Investigators

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Abstract

Background: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagonlike peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated. Methods: ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallelgroup, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk. The primary efficacy end point is a composite of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Data are systematically collected for safety outcomes, including hypoglycemia, pancreatitis, and malignancy. Results: Enrollment began in July 2010 and ended in August 2013; 6,068 patients from 49 countries were randomized. Of these, 69% are men and 75% are white; at baseline, the mean ± SD age was 60.3 ± 9.7 years, body mass index was 30.2 ± 5.7 kg/m2, and duration of T2DM was 9.3±8.2 years. The qualifying ACS wasamyocardial infarctionin83% and unstableangina in 17%. The study will continue until the positive adjudication of the protocol-specified number of primary CV events. Conclusion: ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide 1 receptor agonist in people with T2DM and high CV event risk.

Original languageEnglish
Pages (from-to)631-638.e7
JournalAmerican Heart Journal
Volume169
Issue number5
DOIs
Publication statusPublished - 1 May 2015

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Acute Coronary Syndrome
Type 2 Diabetes Mellitus
Placebos
Morbidity
Safety
Peptide Receptors
Mortality
Unstable Angina
Hypoglycemia
Pancreatitis
Multicenter Studies
Hospitalization
Body Mass Index
Cardiovascular Diseases
Stroke
Myocardial Infarction
ZP10A peptide
Population
Neoplasms

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

@article{e4c7a9ea7bb24d2c80f8d0494ffc00c8,
title = "Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo",
abstract = "Background: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagonlike peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated. Methods: ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallelgroup, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk. The primary efficacy end point is a composite of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Data are systematically collected for safety outcomes, including hypoglycemia, pancreatitis, and malignancy. Results: Enrollment began in July 2010 and ended in August 2013; 6,068 patients from 49 countries were randomized. Of these, 69{\%} are men and 75{\%} are white; at baseline, the mean ± SD age was 60.3 ± 9.7 years, body mass index was 30.2 ± 5.7 kg/m2, and duration of T2DM was 9.3±8.2 years. The qualifying ACS wasamyocardial infarctionin83{\%} and unstableangina in 17{\%}. The study will continue until the positive adjudication of the protocol-specified number of primary CV events. Conclusion: ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide 1 receptor agonist in people with T2DM and high CV event risk.",
author = "{ELIXA Investigators} and Rhonda Bentley-Lewis and David Aguilar and Riddle, {Matthew C.} and Brian Claggett and Rafael Diaz and Kenneth Dickstein and Gerstein, {Hertzel C.} and Peter Johnston and K{\o}ber, {Lars V.} and Francesca Lawson and Lewis, {Eldrin F.} and Maggioni, {Aldo P.} and McMurray, {John J.V.} and Lin Ping and Probstfield, {Jeffrey L.} and Solomon, {Scott D.} and Tardif, {Jean Claude} and Yujun Wu and Pfeffer, {Marc A.} and Ebrahim Barkoudah and Abdel Brahimi and David Charytan and Peter Finn and Aiden Flynn and Hartley, {L. Howard} and Galen Henderson and Jacob Joseph and Kayode Odutayo and Vinutha Rajesh and Ali Vazir and Larry Weinrauch and {Del Prato}, Stefano and John Petrie and Allen Kaplan and Phil Lieberman and Zuraw, {Bruce L.} and Eileen O'Reilly and Keyur Patel and Peter Allen and Aldo Scarpa and Mark Schattner and Christopher Granger and Jean Rouleau and David DeMets and Nishi Chaturvedi and Denis Raccah and Diego Aizenberg and Carlos Alvarez and Andres Alvarisqueta and Rayaz Malik",
year = "2015",
month = "5",
day = "1",
doi = "10.1016/j.ahj.2015.02.002",
language = "English",
volume = "169",
pages = "631--638.e7",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby Inc.",
number = "5",

}

TY - JOUR

T1 - Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo

AU - ELIXA Investigators

AU - Bentley-Lewis, Rhonda

AU - Aguilar, David

AU - Riddle, Matthew C.

AU - Claggett, Brian

AU - Diaz, Rafael

AU - Dickstein, Kenneth

AU - Gerstein, Hertzel C.

AU - Johnston, Peter

AU - Køber, Lars V.

AU - Lawson, Francesca

AU - Lewis, Eldrin F.

AU - Maggioni, Aldo P.

AU - McMurray, John J.V.

AU - Ping, Lin

AU - Probstfield, Jeffrey L.

AU - Solomon, Scott D.

AU - Tardif, Jean Claude

AU - Wu, Yujun

AU - Pfeffer, Marc A.

AU - Barkoudah, Ebrahim

AU - Brahimi, Abdel

AU - Charytan, David

AU - Finn, Peter

AU - Flynn, Aiden

AU - Hartley, L. Howard

AU - Henderson, Galen

AU - Joseph, Jacob

AU - Odutayo, Kayode

AU - Rajesh, Vinutha

AU - Vazir, Ali

AU - Weinrauch, Larry

AU - Del Prato, Stefano

AU - Petrie, John

AU - Kaplan, Allen

AU - Lieberman, Phil

AU - Zuraw, Bruce L.

AU - O'Reilly, Eileen

AU - Patel, Keyur

AU - Allen, Peter

AU - Scarpa, Aldo

AU - Schattner, Mark

AU - Granger, Christopher

AU - Rouleau, Jean

AU - DeMets, David

AU - Chaturvedi, Nishi

AU - Raccah, Denis

AU - Aizenberg, Diego

AU - Alvarez, Carlos

AU - Alvarisqueta, Andres

AU - Malik, Rayaz

PY - 2015/5/1

Y1 - 2015/5/1

N2 - Background: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagonlike peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated. Methods: ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallelgroup, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk. The primary efficacy end point is a composite of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Data are systematically collected for safety outcomes, including hypoglycemia, pancreatitis, and malignancy. Results: Enrollment began in July 2010 and ended in August 2013; 6,068 patients from 49 countries were randomized. Of these, 69% are men and 75% are white; at baseline, the mean ± SD age was 60.3 ± 9.7 years, body mass index was 30.2 ± 5.7 kg/m2, and duration of T2DM was 9.3±8.2 years. The qualifying ACS wasamyocardial infarctionin83% and unstableangina in 17%. The study will continue until the positive adjudication of the protocol-specified number of primary CV events. Conclusion: ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide 1 receptor agonist in people with T2DM and high CV event risk.

AB - Background: Cardiovascular (CV) disease is the leading cause of morbidity and mortality in patients with type 2 diabetes mellitus (T2DM). Furthermore, patients with T2DM and acute coronary syndrome (ACS) have a particularly high risk of CV events. The glucagonlike peptide 1 receptor agonist, lixisenatide, improves glycemia, but its effects on CV events have not been thoroughly evaluated. Methods: ELIXA (www.clinicaltrials.gov no. NCT01147250) is a randomized, double-blind, placebo-controlled, parallelgroup, multicenter study of lixisenatide in patients with T2DM and a recent ACS event. The primary aim is to evaluate the effects of lixisenatide on CV morbidity and mortality in a population at high CV risk. The primary efficacy end point is a composite of time to CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. Data are systematically collected for safety outcomes, including hypoglycemia, pancreatitis, and malignancy. Results: Enrollment began in July 2010 and ended in August 2013; 6,068 patients from 49 countries were randomized. Of these, 69% are men and 75% are white; at baseline, the mean ± SD age was 60.3 ± 9.7 years, body mass index was 30.2 ± 5.7 kg/m2, and duration of T2DM was 9.3±8.2 years. The qualifying ACS wasamyocardial infarctionin83% and unstableangina in 17%. The study will continue until the positive adjudication of the protocol-specified number of primary CV events. Conclusion: ELIXA will be the first trial to report the safety and efficacy of a glucagon-like peptide 1 receptor agonist in people with T2DM and high CV event risk.

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U2 - 10.1016/j.ahj.2015.02.002

DO - 10.1016/j.ahj.2015.02.002

M3 - Article

VL - 169

SP - 631-638.e7

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 5

ER -