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dc.contributor.authorScirica, Benjamin M.en_US
dc.contributor.authorBhatt, Deepak L.en_US
dc.contributor.authorBraunwald, Eugeneen_US
dc.contributor.authorGabriel Steg, P.en_US
dc.contributor.authorDavidson, Jaimeen_US
dc.contributor.authorHirshberg, Boazen_US
dc.contributor.authorOhman, Peteren_US
dc.contributor.authorFrederich, Roberten_US
dc.contributor.authorWiviott, Stephen D.en_US
dc.contributor.authorHoffman, Elaine B.en_US
dc.contributor.authorCavender, Matthew A.en_US
dc.contributor.authorUdell, Jacob A.en_US
dc.contributor.authorDesai, Nihar R.en_US
dc.contributor.authorMosenzon, Ofrien_US
dc.contributor.authorMcGuire, Darren K.en_US
dc.contributor.authorRay, Kausik K.en_US
dc.contributor.authorLeiter, Lawrence A.en_US
dc.contributor.authorRaz, Itamaren_US
dc.contributor.authorJayasinghe, Rohanen_US
dc.date.accessioned2018-12-12T01:31:10Z
dc.date.available2018-12-12T01:31:10Z
dc.date.issued2013en_US
dc.identifier.issn00284793en_US
dc.identifier.doi10.1056/NEJMoa1307684en_US
dc.identifier.urihttp://hdl.handle.net/10072/67407
dc.description.abstractBACKGROUND: 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. (Funded by AstraZeneca and Bristol-Myers Squibb; SAVOR-TIMI 53 ClinicalTrials.gov number, NCT01107886.)en_US
dc.description.peerreviewedYesen_US
dc.description.publicationstatusYesen_US
dc.languageEnglishen_US
dc.publisherMassachusetts Medical Societyen_US
dc.publisher.placeUnited Statesen_US
dc.relation.ispartofstudentpublicationNen_US
dc.relation.ispartofpagefrom1317en_US
dc.relation.ispartofpageto1326en_US
dc.relation.ispartofissue14en_US
dc.relation.ispartofjournalThe New England Journal of Medicineen_US
dc.relation.ispartofvolume369en_US
dc.rights.retentionYen_US
dc.subject.fieldofresearchMedical and Health Sciences not elsewhere classifieden_US
dc.subject.fieldofresearchcode119999en_US
dc.titleSaxagliptin and cardiovascular outcomes in patients with type 2 diabetes mellitusen_US
dc.typeJournal articleen_US
dc.type.descriptionC1 - Peer Reviewed (HERDC)en_US
dc.type.codeC - Journal Articlesen_US
dc.description.versionPublisheden_US
gro.rights.copyright© 2013 Massachusetts Medical Society. The attached file is reproduced here in accordance with the copyright policy of the publisher. Please refer to the journal's website for access to the definitive, published version.en_US
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