Alogliptin after acute coronary syndrome in patients with type 2 diabetes.

By W. White, C. Cannon, S. Heller, S. Nissen, R. Bergenstal, G. Bakris, Alfonso T. Perez, P. Fleck, C. Mehta, S. Kupfer and 3 more. New England Journal of Medicine, 2013

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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. (Funded by Takeda Development Center Americas; EXAMINE ClinicalTrials.gov number, NCT00968708.).

Subfields: Cardiology and Cardiovascular Medicine, Endocrinology, Diabetes and Metabolism

View Paper: https://www.semanticscholar.org/paper/d9095d92ffbad6f7e450316f246e18a4ab68d2c7

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In Endocrinology, Diabetes and Metabolism

Citations in the corpus

GLP-1 receptor agonists in the treatment of type 2 diabetes – state-of-the-art (2020, neutral): “Numbers in symbols identify the clinical trials: 1: REWIND (dulaglutide) [98], 4: LEADER (liraglutide) [96], 5: EXCSEL (once-weekly exeDECLARE-TIMI-58 (dapagliflozin) [121], 9: CANVAS program (canagliflozin) [122]; 10: es Association); 11: EXAMINE (alogliptin) [123], 12 CARMELINA (linagliptin) [124]”
Management of hyperglycaemia in type 2 diabetes, 2018. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) (2018, background): “3% with placebo) [59], and in the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), the rate of hospitalisation for HF was 3.”
Management of hyperglycaemia in type 2 diabetes, 2015: a patient-centred approach. Update to a Position Statement of the American Diabetes Association and the European Association for the Study of Diabetes (2015, background): “A wider database interrogation indicated no signal for cardiovascular disease or heart failure [30, 31].”