Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus

Scirica, Benjamin M., Bhatt, Deepak L., Braunwald, Eugene, Steg, P. Gabriel, Davidson, Jaime, Hirshberg, Boaz, Ohman, Peter, Frederich, Robert, Wiviott, Stephen D., Hoffman, Elaine B., Cavender, Matthew A., Udell, Jacob A., Desai, Nihar R., Mosenzon, Ofri, McGuire, Darren K., Ray, Kausik K., Leiter, Lawrence A., Raz, Itamar, SAVOR-TIMI 53 Steering Committee and Investigators and Colquhoun, D. (2013) Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus. New England Journal of Medicine, 369 14: 1317-1326. doi:10.1056/NEJMoa1307684

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Author Scirica, Benjamin M.
Bhatt, Deepak L.
Braunwald, Eugene
Steg, P. Gabriel
Davidson, Jaime
Hirshberg, Boaz
Ohman, Peter
Frederich, Robert
Wiviott, Stephen D.
Hoffman, Elaine B.
Cavender, Matthew A.
Udell, Jacob A.
Desai, Nihar R.
Mosenzon, Ofri
McGuire, Darren K.
Ray, Kausik K.
Leiter, Lawrence A.
Raz, Itamar
SAVOR-TIMI 53 Steering Committee and Investigators
Colquhoun, D.
Title Saxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitus
Journal name New England Journal of Medicine   Check publisher's open access policy
ISSN 0028-4793
1533-4406
Publication date 2013-01-01
Year available 2013
Sub-type Article (original research)
DOI 10.1056/NEJMoa1307684
Open Access Status File (Publisher version)
Volume 369
Issue 14
Start page 1317
End page 1326
Total pages 10
Place of publication Waltham, MA, United States
Publisher Massachusetts Medical Society
Language eng
Subject 2700 Medicine
Abstract BackgroundThe cardiovascular safety and efficacy of many current antihyperglycemic agents, including saxagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, are unclear.
Formatted abstract
BACKGROUND:
The cardiovascular safety and efficacy of many current antihyperglycemic agents, including saxagliptin, a dipeptidyl peptidase 4 (DPP-4) inhibitor, are unclear.

METHODS: We randomly assigned 16,492 patients with type 2 diabetes who had a history of, or were at risk for, cardiovascular events to receive saxagliptin or placebo and followed them for a median of 2.1 years. Physicians were permitted to adjust other medications, including antihyperglycemic agents. The primary end point was a composite of cardiovascular death, myocardial infarction, or ischemic stroke.

RESULTS: A primary end-point event occurred in 613 patients in the saxagliptin group and in 609 patients in the placebo group (7.3% and 7.2%, respectively, according to 2-year Kaplan-Meier estimates; hazard ratio with saxagliptin, 1.00; 95% confidence interval [CI], 0.89 to 1.12; P=0.99 for superiority; P<0.001 for noninferiority); the results were similar in the "on-treatment" analysis (hazard ratio, 1.03; 95% CI, 0.91 to 1.17). The major secondary end point of a composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, coronary revascularization, or heart failure occurred in 1059 patients in the saxagliptin group and in 1034 patients in the placebo group (12.8% and 12.4%, respectively, according to 2-year Kaplan-Meier estimates; hazard ratio, 1.02; 95% CI, 0.94 to 1.11; P=0.66). More patients in the saxagliptin group than in the placebo group were hospitalized for heart failure (3.5% vs. 2.8%; hazard ratio, 1.27; 95% CI, 1.07 to 1.51; P=0.007). Rates of adjudicated cases of acute and chronic pancreatitis were similar in the two groups (acute pancreatitis, 0.3% in the saxagliptin group and 0.2% in the placebo group; chronic pancreatitis, <0.1% and 0.1% in the two groups, respectively).

CONCLUSIONS: DPP-4 inhibition with saxagliptin did not increase or decrease the rate of ischemic events, though the rate of hospitalization for heart failure was increased. Although saxagliptin improves glycemic control, other approaches are necessary to reduce cardiovascular risk in patients with diabetes. 
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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