Alogliptin after acute coronary syndrome in patients with type 2 diabetes

White, William B., Cannon, Christopher P., Heller, Simon R., Nissen, Steven E., Bergenstal, Richard M., Bakris, George L., Perez, Alfonso T., Fleck, Penny R., Mehta, Cyrus R., Kupfer, Stuart, Wilson, Craig, Cushman, William C. and Zannad, Faiez (2013) Alogliptin after acute coronary syndrome in patients with type 2 diabetes. New England Journal of Medicine, 369 14: 1327-1335. doi:10.1056/NEJMoa1305889

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Author White, William B.
Cannon, Christopher P.
Heller, Simon R.
Nissen, Steven E.
Bergenstal, Richard M.
Bakris, George L.
Perez, Alfonso T.
Fleck, Penny R.
Mehta, Cyrus R.
Kupfer, Stuart
Wilson, Craig
Cushman, William C.
Zannad, Faiez
Title Alogliptin after acute coronary syndrome in patients with type 2 diabetes
Journal name New England Journal of Medicine   Check publisher's open access policy
ISSN 0028-4793
1533-4406
Publication date 2013-10-03
Year available 2013
Sub-type Article (original research)
DOI 10.1056/NEJMoa1305889
Open Access Status File (Publisher version)
Volume 369
Issue 14
Start page 1327
End page 1335
Total pages 9
Place of publication Waltham, MA, United States
Publisher Massachusetts Medical Society
Language eng
Formatted 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. 
Keyword Medicine, General & Internal
General & Internal Medicine
MEDICINE, GENERAL & INTERNAL
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status Non-UQ

Document type: Journal Article
Sub-type: Article (original research)
Collection: School of Medicine Publications
 
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