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DABIGATRAN RECOMMENDED FOR EUROPE-WIDE AF APPROVAL

Dabigatran etexilate has recently been recommended for approval in EU member states by the Committee for Medicinal Products for Human Use (CHMP), for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (AF).

CHMP recommends1 the oral anticoagulant (Pradaxa®, Boehringer Ingelheim) for patients with one or more of the following risk factors:

  • Previous stroke
  • Transient ischemic attack, or systemic embolism (SEE)
  • Left ventricular ejection fraction < 40 %
  • Symptomatic heart failure, ≥ New York Heart Association (NYHA) Class 2
  • Age ≥ 75 years
  • Age ≥ 65 years associated with one of the following: diabetes mellitus, coronary artery disease, or hypertension.

CHMP’s decision was supported by the results of the Randomised Evaluation of Long-term Anticoagulation Therapy (RE-LY) trial, a prospective, randomised study which compared two fixed doses of dabigatran etexilate (110 mg and 150 mg bid) with open label warfarin in 18,113 patients.  The trial found that dabigatran etexilate 150 mg bid reduced the risk of stroke and systemic embolism by 35%, as well as reducing the risk of potentially fatal intracranial bleeding compared to warfarin.

Dabgatran has already been approved for stroke risk reduction in patients with AF in the USA, Canada, Japan, South Korea, New Zealand, Israel, Malaysia, Philippines, Singapore, Namibia, Colombia, Netherlands Antilles, Suriname and Indonesia.

References

1 Full CHMP indication available from www.ema.europa.euhttp://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000829/smops/Positive/human_smop_000216.jsp&mid=WC0b01ac058001d127&murl=menus/medicines/medicines.jsp

Published on: May 6, 2011

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ENDORSED BY

  • ArrhythmiaAlliance
  • Stars
  • Anticoagulation Europe
  • Atrial Fibrillation Association
 

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