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A new study confirms the effectiveness and safety of an agent that reverses the action of the blood thinner dabigatran.
Results of the RE-VERSE AD clinical trial were published recently in The New England Journal of Medicine.
“In emergency situations, idarucizumab rapidly, durably, and safely reversed the anticoagulant effect of dabigatran,” an international team of researchers conclude from the industry-funded study.
Background information in the article notes that about 28 million prescriptions for blood thinners are filled by pharmacists annually for atrial fibrillation, deep vein thrombosis, and other conditions. In rare cases, those patients end up at the emergency department because of accidental bleeding and hemorrhage related to their medications.
“Prior to idarucizumab, there was no rapid, reliable, and effective method for reversing dabigatran and other orally administered blood thinners, which otherwise may take at least 12 to 24 hours to clear from the body,” explains lead author Charles Pollack, MD, professor of Emergency Medicine at Sidney Kimmel Medical College of Thomas Jefferson University. “Physicians will now have a potentially life-saving option for treating patients at risk of uncontrolled bleeding or in need of emergency surgery.”
The study, which included 503 patients taking dabigatran with an urgent medical need to reverse the blood thinner, was conducted in 39 countries between 2014 and 2016. Participants were divided into two groups — one including patients with uncontrolled bleeding or hemorrhage, and the other with patients requiring emergency surgery that could not be safely performed while the patient was affected by anticoagulants.
Patients were given one dose of five grams of idarucizumab, with only nine requiring a second dose. Blood was evaluated for clotting ability before the reversal agent was administered, and then at six points afterward.
Results indicated that idarucizumab returned patients to normal clotting function within minutes of administration; the first tested time point was between 10-30 minutes after the dosage was received.
In patients with uncontrolled bleeding, meanwhile, idarucizumab stemmed the bleeding within a median of 2.5 hours. In fact, patients requiring surgery were able to begin the procedure an average of 1.6 hours after dosing.
The reversal agent from Boehringer Ingelheim Pharmaceuticals is made from an antibody segment that functions by binding tightly and specifically to dabigatran and preventing the anticoagulant effects. The study emphasized that idarucizumab is not an antidote to other anticoagulants.
In 2015, interim results of RE-VERSE AD were published based on analysis of results from 90 patients. Using that data, both the U.S. Food and Drug Administration and the European Medicines Agency granted approval for use of the drug in emergency settings.
Now, the new study reaffirms the interim findings. “For the first time we have the ability to turn off oral anticoagulation like a light switch,” Pollack says. “In the past, we haven’t had the ability to do that.”