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

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Author(s)
Rury R. HolmanRobert J. MentzVivian P. ThompsonYuliya LokhnyginaJohn B. BuseJuliana C. ChanJasmine Choi, M.S., Stephanie M. GustavsonNayyar IqbalAldo P. MaggioniSteven P. MarsoPeter ÖhmanNeha J. PagidipatiNeil PoulterAmbady RamachandranBernard ZinmanAdrian F. Hernandezfor the EXSCEL Study GroupM. Angelyn Bethel
Keimyung Author(s)
Kim, Yoon NyunNam, Chang Wook
Department
Dept. of Internal Medicine (내과학)
Journal Title
New England Journal of Medicine
Issued Date
2017
Volume
377
Issue
13
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.
Keimyung Author(s)(Kor)
김윤년
남창욱
Publisher
School of Medicine (의과대학)
Citation
Rury R. Holman et al. (2017). Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes. New England Journal of Medicine, 377(13), 1228–1239. doi: 10.1056/NEJMoa1612917
Type
Article
ISSN
0028-4793
DOI
10.1056/NEJMoa1612917
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/41218
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Internal Medicine (내과학)
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