Baseline characteristics of patients enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL)

Robert J. Mentz, M. Angelyn Bethel, Stephanie Gustavson, Vivian P. Thompson, Neha J. Pagidipati, John B Buse, Juliana C. Chan, Nayyar Iqbal, Aldo P. Maggioni, Steve P. Marso, Peter Ohman, Neil Poulter, Ambady Ramachandran, Bernard Zinman, Adrian F. Hernandez, Rury R. Holman

Research output: Contribution to journalArticle

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Abstract

Background EXSCEL is a randomized, double-blind, placebo-controlled trial examining the effect of exenatide once-weekly (EQW) versus placebo on time to the primary composite outcome (cardiovascular death, nonfatal myocardial infarction or nonfatal stroke) in patients with type 2 diabetes mellitus (DM) and a wide range of cardiovascular (CV) risk. Methods Patients were enrolled at 688 sites in 35 countries. We describe their baseline characteristics according to prior CV event status and compare patients with those enrolled in prior glucagon-like peptide-1 receptor agonist (GLP-1RA) outcomes trials. Results Of a total of 14,752 participants randomized between June 2010 and September 2015, 6,788 (46.0%) patients were enrolled in Europe; 3,708 (25.1%), North America; 2,727 (18.5%), Latin America; and 1,529 (10.4%), Asia Pacific. Overall, 73% had at least one prior CV event (70% coronary artery disease, 24% peripheral arterial disease, 22% cerebrovascular disease). The median (IQR) age was 63 years (56, 69), 38% were female, median baseline HbA1c was 8.0% (7.3, 8.9) and 16% had a prior history of heart failure. Those without a prior CV event were younger with a shorter duration of diabetes and better renal function than those with at least one prior CV event. Compared with prior GLP-1RA trials, EXSCEL has a larger percentage of patients without a prior CV event and a notable percentage who were taking a dipeptidyl peptidase-4 inhibitor at baseline (15%). Conclusions EXSCEL is one of the largest global GLP-1RA trials, evaluating the safety and efficacy of EQW with a broad patient population that may extend generalizability compared to prior GLP-1RA trials (ClinicalTrials.gov number, NCT01144338).

LanguageEnglish (US)
Pages1-9
Number of pages9
JournalAmerican heart journal
Volume187
DOIs
StatePublished - May 1 2017

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Placebos
Dipeptidyl-Peptidase IV Inhibitors
Cerebrovascular Disorders
Latin America
Peripheral Arterial Disease
North America
Type 2 Diabetes Mellitus
exenatide
Coronary Artery Disease
Heart Failure
Stroke
Myocardial Infarction
Kidney
Safety
Glucagon-Like Peptide-1 Receptor
Population

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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Baseline characteristics of patients enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). / Mentz, Robert J.; Bethel, M. Angelyn; Gustavson, Stephanie; Thompson, Vivian P.; Pagidipati, Neha J.; Buse, John B; Chan, Juliana C.; Iqbal, Nayyar; Maggioni, Aldo P.; Marso, Steve P.; Ohman, Peter; Poulter, Neil; Ramachandran, Ambady; Zinman, Bernard; Hernandez, Adrian F.; Holman, Rury R.

In: American heart journal, Vol. 187, 01.05.2017, p. 1-9.

Research output: Contribution to journalArticle

Mentz, RJ, Bethel, MA, Gustavson, S, Thompson, VP, Pagidipati, NJ, Buse, JB, Chan, JC, Iqbal, N, Maggioni, AP, Marso, SP, Ohman, P, Poulter, N, Ramachandran, A, Zinman, B, Hernandez, AF & Holman, RR 2017, 'Baseline characteristics of patients enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL)' American heart journal, vol. 187, pp. 1-9. https://doi.org/10.1016/j.ahj.2017.02.005
Mentz, Robert J. ; Bethel, M. Angelyn ; Gustavson, Stephanie ; Thompson, Vivian P. ; Pagidipati, Neha J. ; Buse, John B ; Chan, Juliana C. ; Iqbal, Nayyar ; Maggioni, Aldo P. ; Marso, Steve P. ; Ohman, Peter ; Poulter, Neil ; Ramachandran, Ambady ; Zinman, Bernard ; Hernandez, Adrian F. ; Holman, Rury R. / Baseline characteristics of patients enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL). In: American heart journal. 2017 ; Vol. 187. pp. 1-9.
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abstract = "Background EXSCEL is a randomized, double-blind, placebo-controlled trial examining the effect of exenatide once-weekly (EQW) versus placebo on time to the primary composite outcome (cardiovascular death, nonfatal myocardial infarction or nonfatal stroke) in patients with type 2 diabetes mellitus (DM) and a wide range of cardiovascular (CV) risk. Methods Patients were enrolled at 688 sites in 35 countries. We describe their baseline characteristics according to prior CV event status and compare patients with those enrolled in prior glucagon-like peptide-1 receptor agonist (GLP-1RA) outcomes trials. Results Of a total of 14,752 participants randomized between June 2010 and September 2015, 6,788 (46.0{\%}) patients were enrolled in Europe; 3,708 (25.1{\%}), North America; 2,727 (18.5{\%}), Latin America; and 1,529 (10.4{\%}), Asia Pacific. Overall, 73{\%} had at least one prior CV event (70{\%} coronary artery disease, 24{\%} peripheral arterial disease, 22{\%} cerebrovascular disease). The median (IQR) age was 63 years (56, 69), 38{\%} were female, median baseline HbA1c was 8.0{\%} (7.3, 8.9) and 16{\%} had a prior history of heart failure. Those without a prior CV event were younger with a shorter duration of diabetes and better renal function than those with at least one prior CV event. Compared with prior GLP-1RA trials, EXSCEL has a larger percentage of patients without a prior CV event and a notable percentage who were taking a dipeptidyl peptidase-4 inhibitor at baseline (15{\%}). Conclusions EXSCEL is one of the largest global GLP-1RA trials, evaluating the safety and efficacy of EQW with a broad patient population that may extend generalizability compared to prior GLP-1RA trials (ClinicalTrials.gov number, NCT01144338).",
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T1 - Baseline characteristics of patients enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL)

AU - Mentz, Robert J.

AU - Bethel, M. Angelyn

AU - Gustavson, Stephanie

AU - Thompson, Vivian P.

AU - Pagidipati, Neha J.

AU - Buse, John B

AU - Chan, Juliana C.

AU - Iqbal, Nayyar

AU - Maggioni, Aldo P.

AU - Marso, Steve P.

AU - Ohman, Peter

AU - Poulter, Neil

AU - Ramachandran, Ambady

AU - Zinman, Bernard

AU - Hernandez, Adrian F.

AU - Holman, Rury R.

PY - 2017/5/1

Y1 - 2017/5/1

N2 - Background EXSCEL is a randomized, double-blind, placebo-controlled trial examining the effect of exenatide once-weekly (EQW) versus placebo on time to the primary composite outcome (cardiovascular death, nonfatal myocardial infarction or nonfatal stroke) in patients with type 2 diabetes mellitus (DM) and a wide range of cardiovascular (CV) risk. Methods Patients were enrolled at 688 sites in 35 countries. We describe their baseline characteristics according to prior CV event status and compare patients with those enrolled in prior glucagon-like peptide-1 receptor agonist (GLP-1RA) outcomes trials. Results Of a total of 14,752 participants randomized between June 2010 and September 2015, 6,788 (46.0%) patients were enrolled in Europe; 3,708 (25.1%), North America; 2,727 (18.5%), Latin America; and 1,529 (10.4%), Asia Pacific. Overall, 73% had at least one prior CV event (70% coronary artery disease, 24% peripheral arterial disease, 22% cerebrovascular disease). The median (IQR) age was 63 years (56, 69), 38% were female, median baseline HbA1c was 8.0% (7.3, 8.9) and 16% had a prior history of heart failure. Those without a prior CV event were younger with a shorter duration of diabetes and better renal function than those with at least one prior CV event. Compared with prior GLP-1RA trials, EXSCEL has a larger percentage of patients without a prior CV event and a notable percentage who were taking a dipeptidyl peptidase-4 inhibitor at baseline (15%). Conclusions EXSCEL is one of the largest global GLP-1RA trials, evaluating the safety and efficacy of EQW with a broad patient population that may extend generalizability compared to prior GLP-1RA trials (ClinicalTrials.gov number, NCT01144338).

AB - Background EXSCEL is a randomized, double-blind, placebo-controlled trial examining the effect of exenatide once-weekly (EQW) versus placebo on time to the primary composite outcome (cardiovascular death, nonfatal myocardial infarction or nonfatal stroke) in patients with type 2 diabetes mellitus (DM) and a wide range of cardiovascular (CV) risk. Methods Patients were enrolled at 688 sites in 35 countries. We describe their baseline characteristics according to prior CV event status and compare patients with those enrolled in prior glucagon-like peptide-1 receptor agonist (GLP-1RA) outcomes trials. Results Of a total of 14,752 participants randomized between June 2010 and September 2015, 6,788 (46.0%) patients were enrolled in Europe; 3,708 (25.1%), North America; 2,727 (18.5%), Latin America; and 1,529 (10.4%), Asia Pacific. Overall, 73% had at least one prior CV event (70% coronary artery disease, 24% peripheral arterial disease, 22% cerebrovascular disease). The median (IQR) age was 63 years (56, 69), 38% were female, median baseline HbA1c was 8.0% (7.3, 8.9) and 16% had a prior history of heart failure. Those without a prior CV event were younger with a shorter duration of diabetes and better renal function than those with at least one prior CV event. Compared with prior GLP-1RA trials, EXSCEL has a larger percentage of patients without a prior CV event and a notable percentage who were taking a dipeptidyl peptidase-4 inhibitor at baseline (15%). Conclusions EXSCEL is one of the largest global GLP-1RA trials, evaluating the safety and efficacy of EQW with a broad patient population that may extend generalizability compared to prior GLP-1RA trials (ClinicalTrials.gov number, NCT01144338).

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