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Heart failure and mortality outcomes in patients with type 2 diabetes taking alogliptin versus placebo in EXAMINE: a

Faiez Zannad1, Christopher P Cannon2, William C Cushman3

  • 1Institut Lorrain du Coeur et des Vaisseaux, Centre d'Investigation Clinique Inserm, Université de Lorraine and CHU, Vandoeuvre-Les-Nancy, France.

Lancet (London, England)
|March 14, 2015
PubMed

Insights

Alogliptin, a DPP-4 inhibitor, did not increase heart failure risk in patients with type 2 diabetes and recent acute coronary syndromes. This finding addresses concerns about DPP-4 inhibitors and heart failure events.

Area of Science:

  • Cardiology
  • Endocrinology
  • Pharmacology

Background:

  • The EXAMINE trial demonstrated alogliptin's non-inferiority to placebo for major adverse cardiac events (MACE) in type 2 diabetes patients post-acute coronary syndrome.
  • Concerns regarding heart failure risk with DPP-4 inhibitors necessitated a specific assessment within the EXAMINE trial.

Purpose of the Study:

  • To evaluate the risk of hospital admission for heart failure associated with alogliptin use.
  • To analyze heart failure outcomes in patients with type 2 diabetes and recent acute coronary syndromes.

Main Methods:

  • Patients with type 2 diabetes and recent ACS were randomized to alogliptin or placebo.
  • Heart failure hospital admissions were assessed as part of an exploratory MACE endpoint and in post-hoc analyses.
  • Baseline and follow-up N-terminal pro-BNP (NT-pro-BNP) levels were analyzed.

Main Results:

  • Hospital admission for heart failure occurred in 3.1% of alogliptin recipients versus 2.9% of placebo recipients (HR 1.07, 95% CI 0.79-1.46).
  • Alogliptin showed no effect on composite cardiovascular death and heart failure hospitalization events.
  • NT-pro-BNP levels decreased similarly in both treatment groups.

Conclusions:

  • Alogliptin does not elevate the risk of heart failure hospitalizations in patients with type 2 diabetes and recent acute coronary syndromes.
  • The findings suggest a favorable safety profile regarding heart failure for alogliptin in this high-risk population.
Abstract

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