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AHA: Antidote to Anti-Clotting Drug Effective, Well Tolerated

Antibody fragment reverses dabigatran-induced anticoagulation

TUESDAY, Nov. 19, 2013 (HealthDay News) -- An antibody fragment is safe, well tolerated, and effectively reverses dabigatran-induced anticoagulation, according to a study presented at the American Heart Association's 2013 Scientific Sessions, held from Nov. 16 to 19 in Dallas.

Stephan Glund, Ph.D., from Boehringer Ingelheim in Biberach an der Riss, Germany, and colleagues treated 145 healthy males with a specific antibody fragment (Fab) that binds the anti-clotting drug dabigatran with high affinity and prevents dabigatran inhibition of thrombin. Subjects were first treated with increasing doses up to 8 g to assess safety and tolerability. Next, subjects were treated with 1 g, 2 g, and 4 g Fab as five minute intravenous infusions in the presence of dabigatran.

The researchers found that the Fab was safe and well tolerated at all doses. The Fab bound to dabigatran and reversed its anti-coagulant effect after infusion. Clotting assays showed the Fab also reversed the prolongation of clotting time induced by dabigatran to baseline in a dose-dependent manner. Reversal was complete and sustained in all subjects at a dose of 4 g.

"The dabigatran antidote was well tolerated and led to immediate, complete, and sustained reversal of dabigatran-induced anticoagulation in healthy male volunteers," Glund and colleagues conclude.

One author is employed by SGS Life Science Services. All other authors are employed by Boehringer Ingelheim.

Abstract (http://www.abstractsonline.com/Plan/ViewAbstract.aspx?sKey=c2d1f570-0c15-4fb3-a538-e0b82ef8f310&cKey=4a2272e7-03d3-4d59-8bd7-1cfd6889e83e&mKey=951e351e-429c-4b2e-84d0-8da73b00de45 )More Information (http://my.americanheart.org/professional/Sessions/ScientificSessions/Scientific-Sessions_UCM_316900_SubHomePage.jsp )