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Am Heart J. 2017 May;187:1-9. doi: 10.1016/j.ahj.2017.02.005. Epub 2017 Feb 12.

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

Author information

1
Duke Clinical Research Institute, Durham, NC. Electronic address: robert.mentz@duke.edu.
2
Diabetes Trials Unit, University of Oxford, Oxford, UK.
3
AstraZeneca Research and Development, Gaithersburg, MD.
4
Duke Clinical Research Institute, Durham, NC.
5
University of North Carolina at Chapel Hill, Chapel Hill, NC.
6
The Chinese University of Hong Kong, Hong Kong, SAR, China.
7
ANMCO Research Centre, Florence, Italy.
8
University of Texas Southwestern Medical Center, Dallas, TX.
9
International Centre for Circulatory Health, NHLI, Imperial College London, London, UK.
10
India Diabetes Research Foundation and Dr. A. Ramachandran's Diabetes Hospitals, Chennai, India.
11
Lunenfeld Tanenbaum Research Institute, Mount Sinai Hospital and University of Toronto, Toronto, Ontario, Canada.

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).

PMID:
28454792
DOI:
10.1016/j.ahj.2017.02.005
[Indexed for MEDLINE]

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