Search
The New England Journal of Medicine and Lancet both published studies evaluating idarucizumab for reversal of dabigatran. It is a monoclonal antibody fragment that binds dabigatran with high affinity. Dr. Ryan Radecki summarizes the two articles on his EM Lit of Note blog.
Here are a few take home points from these early studies:
- Both studies were funded by Boehringer Ingelheim, who not suprisingly also markets dabigatran. Skepticism is always welcome when the same company makes the drug and the antidote.
- The Lancet study was conducted in healthy volunteers, while the NEJM study was conducted in patients needing reversal but lacked a control group.
- Idarucizumab seems to reverse laboratory markers of anticoagulation from dabigatran rapidly and completely, including dilute thrombin time and ecarin clotting time. Not all institutions have these assays available.
- The dose that seems to 'work' the best is 5 gm given IV (two-2.5 gm infusions given no more than 15 minutes apart).
- Median investigator-reported time to cessation of bleeding was 11.4 hours in the NEJM study.
- 21 of the 90 patients in the NEJM study had 'serious adverse effects' including thrombotic events.
- The acquisition cost of this medication will most assuredly be high if and when it is FDA-approved in the U.S.
References
Pollack CV, et al. Idarucizumab for dabigatran reversal. N Engl J Med. 2015 Jun 22. [Epub ahead of print, PMID 26095746]
Glund S, et al. Safety, tolerability, and efficacy of idarucizumab for the reversal of the anticoagulant effect of dabigatran in health male volunteers: a randomised, placebo-controlled, double-blind phase 1 trial. Lancet. 2015 Jun 15. [Epub ahead of print, PMID 26088268]
Follow me on Twitter (@PharmERToxGuy) or Google Plus (+bryanhayes13)