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Safety and Experience | Pradaxa® (dabigatran etexilate) Skip to main content

NVAF=non‑valvular atrial fibrillation; DVT=deep venous thrombosis; PE=pulmonary embolism; AF=atrial fibrillation; AHA=American Heart Association; ASA=American Stroke Association; ACC=American College of Cardiology; HRS=Heart Rhythm Society; AAN=American Academy of Neurology; GI=gastrointestinal

*Composite of confirmed VTE (proximal or distal DVT on venogram, confirmed symptomatic DVT, or confirmed PE) and all-cause death.
Findings were consistent with results of the pivotal RE‑LY® Trial, with the exception of the MI finding. An increased risk of MI was observed for PRADAXA compared to warfarin in RE-LY®.
Source: IMS Health, NPA Audit for the period of October 2010 through December 2015 (Retail + Mail Order + Long-term Care Only). 
§Source: IMS Health, Custom PRADAXA Patient-Level Data, January 2016 (Retail + Mail Order Only).
llPercentage excludes plans where information on PRADAXA coverage is not provided.

  • References:
  • 1. Data on File. Boehringer Ingelheim Pharmaceuticals, Inc.
  • 2. Pradaxa [prescribing information]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.
  • 3. Southworth MR, Reichman ME, Unger EF. Dabigatran and postmarketing reports of bleeding. N Engl J Med. 2013;368(14):1272‑1274.
  • 4. Graham DJ, Reichman ME, Wernecke M, et al. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation. 2015;131(2):157‑164.
  • 5. Villines TC, Schnee J, Fraeman K, et al. A comparison of the safety and effectiveness of dabigatran and warfarin in non‑valvular atrial fibrillation patients in a large healthcare system. Thromb Haemost. 2015;114(6):1290-1298.
  • 6. Seeger JD, Bykov K, Bartels DB, et al. Safety and effectiveness of dabigatran and warfarin in routine care of patients with atrial fibrillation. Thromb Haemost. 2015;114(6):1277-1289.
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  • 10. January CT, Wann LS, Alpert S, et al. 2014 AHA/ACC/HRS Guideline for the Management of Patients With Atrial Fibrillation: Executive Summary. J Am Coll Cardiol. 2014;doi:10.1016/j.jacc.2014.03.021.
  • 11. Bushnell C, McCullough LD, Awad lA, et al; on behalf of the American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, Council on Epidemiology and Prevention, and Council for High Blood Pressure Research. Guidelines for the prevention of stroke in women: a statement for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2014;45(5):1545‑1588.
  • 12. Culebras A, Messe SR, Chaturvedi S, et al. Summary of evidence‑based guideline update: prevention of stroke in nonvalvular atrial fibrillation: report of the Guideline Development Subcommittee of the American Academy of Neurology. Neurology. 2014;82(8):716‑724.