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Cardiovascular Outcomes of Patients in SAVOR-TIMI 53 by Baseline Hemoglobin A1c

Matthew A Cavender1, Benjamin M Scirica1, Itamar Raz2

  • 1Thrombolysis in Myocardial Infarction (TIMI) Study Group, Heart and Vascular Center, Brigham and Women's Hospital, and Harvard Medical School, Boston, Mass.

The American Journal of Medicine
|November 3, 2015
PubMed

Insights

Higher baseline hemoglobin A1c (HbA1c) increases cardiovascular risk in type 2 diabetes patients. Saxagliptin did not alter cardiovascular outcomes across different HbA1c levels in the SAVOR-TIMI 53 trial.

Area of Science:

  • Cardiology
  • Endocrinology
  • Clinical Trials

Background:

  • The impact of saxagliptin on cardiovascular events stratified by baseline hemoglobin A1c (HbA1c) remains underexplored.
  • The SAVOR-TIMI 53 trial provides a unique dataset to investigate this relationship.

Purpose of the Study:

  • To compare the cardiovascular effects of saxagliptin versus placebo in patients with type 2 diabetes based on their baseline HbA1c levels.
  • To assess the association between baseline HbA1c and the risk of major adverse cardiovascular events.

Main Methods:

  • Analysis of 16,492 patients with type 2 diabetes randomized to saxagliptin or placebo in the SAVOR-TIMI 53 trial.
  • Patients were stratified by baseline HbA1c (<7%, 7%-<8%, 8%-<9%, and ≥9%) and followed for a median of 2.1 years.
  • The primary endpoint included cardiovascular death, myocardial infarction, or ischemic stroke.

Main Results:

  • Higher baseline HbA1c (≥7%) was linked to an increased risk of major adverse cardiovascular events (adjusted HR 1.35; 95% CI, 1.17-1.58).
  • Saxagliptin demonstrated no significant effect on cardiovascular outcomes across all HbA1c strata (P-interaction = .89).
  • No significant association was found between baseline HbA1c and hospitalization for heart failure.

Conclusions:

  • Baseline HbA1c independently predicts macrovascular event risk in patients with type 2 diabetes.
  • Saxagliptin's cardiovascular efficacy is consistent across the spectrum of baseline HbA1c levels.
  • The study found no evidence of heterogeneity in saxagliptin's effect on cardiovascular outcomes based on baseline glycemic control.
Abstract

Keywords:
Coronary artery diseaseDiabetes mellitusGlycated hemoglobin assayRandomized clinical trials

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