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

Rhonda Bentley-Lewis; David Aguilar; Matthew C Riddle; Brian Claggett; Rafael Diaz; Kenneth Dickstein; Hertzel C Gerstein; Peter Johnston; Lars V Køber; Francesca Lawson; Eldrin F Lewis; Aldo P Maggioni; John J V McMurray; Lin Ping; Jeffrey L Probstfield; Scott D Solomon; Jean-Claude Tardif; Yujun Wu; Marc A Pfeffer; ELIXA Investigators

doi:10.1016/j.ahj.2015.02.002

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

Rhonda Bentley-Lewis, David Aguilar, Matthew C Riddle, Brian Claggett, Rafael Diaz, Kenneth Dickstein, Hertzel C Gerstein, Peter Johnston, Lars V Køber, Francesca Lawson, Eldrin F Lewis, Aldo P Maggioni, John J V McMurray, Lin Ping, Jeffrey L Probstfield, Scott D Solomon, Jean-Claude Tardif, Yujun Wu, Marc A Pfeffer, ELIXA Investigators

Institut for Klinisk Medicin

74 Citationer (Scopus)

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 glucagon-like 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, parallel-group, 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/m(2), and duration of T2DM was 9.3 ± 8.2 years. The qualifying ACS was a myocardial infarction in 83% and unstable angina 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.

Originalsprog	Engelsk
Tidsskrift	American Heart Journal
Vol/bind	169
Udgave nummer	5
Sider (fra-til)	631-638.e7
ISSN	0002-8703
DOI	https://doi.org/10.1016/j.ahj.2015.02.002
Status	Udgivet - 1 maj 2015

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10.1016/j.ahj.2015.02.002

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Bentley-Lewis, R., Aguilar, D., Riddle, M. C., Claggett, B., Diaz, R., Dickstein, K., Gerstein, H. C., Johnston, P., Køber, L. V., Lawson, F., Lewis, E. F., Maggioni, A. P., McMurray, J. J. V., Ping, L., Probstfield, J. L., Solomon, S. D., Tardif, J-C., Wu, Y., Pfeffer, M. A., & ELIXA Investigators (2015). Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo. American Heart Journal, 169(5), 631-638.e7. https://doi.org/10.1016/j.ahj.2015.02.002

Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo. / Bentley-Lewis, Rhonda; Aguilar, David; Riddle, Matthew C et al.

I: American Heart Journal, Bind 169, Nr. 5, 01.05.2015, s. 631-638.e7.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Bentley-Lewis, R, Aguilar, D, Riddle, MC, Claggett, B, Diaz, R, Dickstein, K, Gerstein, HC, Johnston, P, Køber, LV, Lawson, F, Lewis, EF, Maggioni, AP, McMurray, JJV, Ping, L, Probstfield, JL, Solomon, SD, Tardif, J-C, Wu, Y, Pfeffer, MA & ELIXA Investigators 2015, 'Rationale, design, and baseline characteristics in Evaluation of LIXisenatide in Acute Coronary Syndrome, a long-term cardiovascular end point trial of lixisenatide versus placebo', American Heart Journal, bind 169, nr. 5, s. 631-638.e7. https://doi.org/10.1016/j.ahj.2015.02.002

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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 glucagon-like 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, parallel-group, 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/m(2), and duration of T2DM was 9.3 ± 8.2 years. The qualifying ACS was a myocardial infarction in 83% and unstable angina 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.",

keywords = "Acute Coronary Syndrome, Aged, Cardiovascular Diseases, Double-Blind Method, Female, Glucagon-Like Peptide 1, Humans, Male, Middle Aged, Peptides, Placebos, Protein Kinase Inhibitors, Research Design, p38 Mitogen-Activated Protein Kinases",

author = "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 Jean-Claude Tardif and Yujun Wu and Pfeffer, {Marc A} and {ELIXA Investigators}",

note = "Copyright {\textcopyright} 2015. Published by Elsevier Inc.",

year = "2015",

month = may,

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",

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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 - 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 - ELIXA Investigators

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 glucagon-like 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, parallel-group, 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/m(2), and duration of T2DM was 9.3 ± 8.2 years. The qualifying ACS was a myocardial infarction in 83% and unstable angina 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 glucagon-like 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, parallel-group, 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/m(2), and duration of T2DM was 9.3 ± 8.2 years. The qualifying ACS was a myocardial infarction in 83% and unstable angina 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.

KW - Acute Coronary Syndrome

KW - Aged

KW - Cardiovascular Diseases

KW - Double-Blind Method

KW - Female

KW - Glucagon-Like Peptide 1

KW - Humans

KW - Male

KW - Middle Aged

KW - Peptides

KW - Placebos

KW - Protein Kinase Inhibitors

KW - Research Design

KW - p38 Mitogen-Activated Protein Kinases

U2 - 10.1016/j.ahj.2015.02.002

DO - 10.1016/j.ahj.2015.02.002

M3 - Journal article

C2 - 25965710

SN - 0002-8703

VL - 169

SP - 631-638.e7

JO - American Heart Journal

JF - American Heart Journal

IS - 5

ER -

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

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