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Cardiovascular outcomes during treatment with dabigatran: comprehensive analysis of individual subject data by

Andreas Clemens1, Mandy Fraessdorf, Jeffrey Friedman

  • 1Corporate Division Medicine, TA Cardiovascular, Ingelheim am Rhein, Germany.

Vascular Health and Risk Management
|October 22, 2013
PubMed

Insights

Dabigatran may have a higher risk of myocardial infarction compared to warfarin, but it shows a positive benefit-risk ratio for other cardiovascular events. These findings suggest myocardial infarction is not an adverse reaction to dabigatran.

Area of Science:

  • Cardiology
  • Pharmacology
  • Clinical Trials

Background:

  • Dabigatran 150 mg twice daily proved superior to warfarin in preventing stroke in nonvalvular atrial fibrillation (SPAF).
  • A numerical increase in myocardial infarctions (MI) with dabigatran versus warfarin prompted further cardiovascular outcome analysis.

Purpose of the Study:

  • To comprehensively analyze cardiovascular outcomes, specifically MI, in Phase II and III trials of dabigatran etexilate.
  • To evaluate the safety and efficacy of dabigatran compared to warfarin, enoxaparin, and placebo across various indications.

Main Methods:

  • Pooled analysis of individual patient data from 14 comparative trials (n=42,484) across five indications.
  • Evaluation of cardiovascular events, including MI, comparing dabigatran against warfarin, enoxaparin, and placebo.

Main Results:

  • Pooled analysis showed MI occurrence favored warfarin (OR 1.42, 95% CI 1.07-1.88 for dabigatran 150 mg twice daily).
  • A composite endpoint of MI, stroke, and vascular death was numerically lower with dabigatran 150 mg (OR 0.87, 95% CI 0.77-1.00).
  • Dabigatran demonstrated similar MI rates compared to enoxaparin and placebo.

Conclusions:

  • Well-controlled warfarin may offer more MI protection than dabigatran, but not enoxaparin.
  • Dabigatran exhibited a positive benefit-risk ratio for key cardiovascular composite endpoints.
  • Myocardial infarction is unlikely to be an adverse drug reaction associated with dabigatran use.
Abstract

Keywords:
atrial fibrillationcardiovascular eventsdabigatran etexilatemyocardial infarctionstrokewarfarin

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