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Alogliptin after acute coronary syndrome in patients with type 2 diabetes
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White, W. B., Cannon, C. P., Heller, S. R., Nissen, S. E., Bergenstal, R. M., Bakris, G. L., Perez, A. T., Fleck, P. R., Mehta, C. R., Kupfer, S., Wilson, C., Cushman, W. C. and Zannad, F. (2013) Alogliptin after acute coronary syndrome in patients with type 2 diabetes. The New England Journal of Medicine, Volume 369 (Number 14). pp. 1327-1335. doi:10.1056/NEJMoa1305889 ISSN 0028-4793.
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Official URL: http://dx.doi.org/10.1056/NEJMoa1305889
Abstract
BACKGROUND:
To assess potentially elevated cardiovascular risk related to new antihyperglycemic drugs in patients with type 2 diabetes, regulatory agencies require a comprehensive evaluation of the cardiovascular safety profile of new antidiabetic therapies. We assessed cardiovascular outcomes with alogliptin, a new inhibitor of dipeptidyl peptidase 4 (DPP-4), as compared with placebo in patients with type 2 diabetes who had had a recent acute coronary syndrome.
METHODS:
We randomly assigned patients with type 2 diabetes and either an acute myocardial infarction or unstable angina requiring hospitalization within the previous 15 to 90 days to receive alogliptin or placebo in addition to existing antihyperglycemic and cardiovascular drug therapy. The study design was a double-blind, noninferiority trial with a prespecified noninferiority margin of 1.3 for the hazard ratio for the primary end point of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.
RESULTS:
A total of 5380 patients underwent randomization and were followed for up to 40 months (median, 18 months). A primary end-point event occurred in 305 patients assigned to alogliptin (11.3%) and in 316 patients assigned to placebo (11.8%) (hazard ratio, 0.96; upper boundary of the one-sided repeated confidence interval, 1.16; P<0.001 for noninferiority). Glycated hemoglobin levels were significantly lower with alogliptin than with placebo (mean difference, -0.36 percentage points; P<0.001). Incidences of hypoglycemia, cancer, pancreatitis, and initiation of dialysis were similar with alogliptin and placebo.
CONCLUSIONS:
Among patients with type 2 diabetes who had had a recent acute coronary syndrome, the rates of major adverse cardiovascular events were not increased with the DPP-4 inhibitor alogliptin as compared with placebo.
Item Type: | Journal Article | ||||||
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Subjects: | R Medicine > RC Internal medicine | ||||||
Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||||
Library of Congress Subject Headings (LCSH): | Coronary heart disease, Hypoglycemic agents, Diabetes, Diabetes--Treatment | ||||||
Journal or Publication Title: | The New England Journal of Medicine | ||||||
Publisher: | Massachusetts Medical Society | ||||||
ISSN: | 0028-4793 | ||||||
Official Date: | 3 October 2013 | ||||||
Dates: |
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Volume: | Volume 369 | ||||||
Number: | Number 14 | ||||||
Page Range: | pp. 1327-1335 | ||||||
DOI: | 10.1056/NEJMoa1305889 | ||||||
Status: | Peer Reviewed | ||||||
Publication Status: | Published | ||||||
Access rights to Published version: | Restricted or Subscription Access | ||||||
Funder: | Takeda Development Center Americas | ||||||
Grant number: | NCT00968708 | ||||||
Contributors: |
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