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Alogliptin after acute coronary syndrome in patients with type 2 diabetes

William B White1, Christopher P Cannon, Simon R Heller

  • 1Calhoun Cardiology Center, Department of Medicine, University of Connecticut School of Medicine, 263 Farmington Ave., Farmington, CT 06030-3940, USA. wwhite@nso1.uchc.edu

The New England Journal of Medicine
|September 3, 2013
PubMed
Abstract

Insights

Alogliptin, a DPP-4 inhibitor, did not increase major adverse cardiovascular events in type 2 diabetes patients with recent acute coronary syndrome. This study confirms the cardiovascular safety of alogliptin in this high-risk population.

Area of Science:

  • Cardiology
  • Endocrinology
  • Pharmacology

Background:

  • Regulatory agencies require cardiovascular safety assessments for new antihyperglycemic drugs.
  • Type 2 diabetes patients with recent acute coronary syndrome (ACS) are at elevated cardiovascular risk.
  • Evaluating the cardiovascular safety of dipeptidyl peptidase 4 (DPP-4) inhibitors is crucial.

Purpose of the Study:

  • To assess the cardiovascular outcomes of alogliptin compared to placebo in patients with type 2 diabetes and recent ACS.
  • To determine if alogliptin affects the risk of major adverse cardiovascular events (MACE) in this high-risk population.

Main Methods:

  • A double-blind, noninferiority trial design was employed.
  • 5380 patients with type 2 diabetes and recent ACS were randomized to alogliptin or placebo.
  • The primary endpoint was a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke, with a noninferiority margin of 1.3 for the hazard ratio.

Main Results:

  • Alogliptin was noninferior to placebo regarding MACE (hazard ratio, 0.96; 95% CI, 0.83 to 1.11).
  • Alogliptin significantly reduced glycated hemoglobin levels compared to placebo (mean difference, -0.36%).
  • Incidences of hypoglycemia, cancer, pancreatitis, and dialysis initiation were similar between groups.

Conclusions:

  • Alogliptin did not increase the risk of major adverse cardiovascular events in patients with type 2 diabetes and recent ACS.
  • The DPP-4 inhibitor alogliptin demonstrates a favorable cardiovascular safety profile in this patient cohort.
  • The findings support the use of alogliptin for glycemic control in patients with type 2 diabetes and a history of ACS.

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