Extended Use of Dabigatran, Warfarin, or Placebo in Venous Thromboembolism

 Author Interview: Sam Schulman M.D., FRCPC(C) Professor, Division of Hematology and Thromboembolism, Department of Medicine Associate Professor, Medicine, Karolinska Institute, Stockholm, Sweden Director, Clinical Thromboembolism Program Hamilton Health Sciences, Hamilton General Hospital, Hamilton, OntarioMedicalResearch.com  Author Interview: Sam Schulman M.D., FRCPC(C)
Professor, Division of Hematology and Thromboembolism, Department of Medicine
Associate Professor, Medicine, Karolinska Institute, Stockholm, Sweden
Director, Clinical Thromboembolism Program Hamilton Health Sciences, Hamilton General Hospital, Hamilton, Ontario

MedicalResearch.com: What are the main findings of the study?

Response: Similar effect of dabigatran  as warfarin, 92% risk reduction compared to placebo. The risk of bleeding is reduced by almost 50% compared to warfarin but in comparison with placebo there is an increased risk of minor bleeding. No routine coagulation monitoring or dose adjustments are required, making the treatment convenient for patients and physicians.

MedicalResearch.com: Were any of the findings unexpected?

Response: The increase in acute coronary syndromes with dabigatran versus warfarin was not completely unexpected because there had been a signal before from the RE-LY trial, but compared to placebo there was no increase in those events (in RE-SONATE). Thus, it is possible that warfarin is more protective against acute coronary syndromes but dabigatran doesn’t cause those events.

MedicalResearch.com: What should clinicians and patients take away from your report?

Response: They should know that there is an increasing number of alternatives for extended treatment of venous thromboembolism.

When the risk for new events is considered increased the treatment now doesn’t have to end at 6 months for reasons of inconvenience or fear of bleeding.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Future research should concentrate on various aspects of real life management of the drug.

Citation:

Extended use of dabigatran, warfarin, or placebo in venous thromboembolism.

Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ; RE-MEDY Trial Investigators; RE-SONATE Trial Investigators.
N Engl J Med. 2013 Feb 21;368(8):709-18. doi: 10.1056/NEJMoa1113697

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