Treatment rapidly reverses the effect of blood thinner dabigatran

At least 28 million prescriptions for blood thinners are filled by pharmacists yearly for the irregular heartbeat of atrial fibrillation, deep vein thrombosis, and other indications, according to the Department of Health and Human Services. However, on rare occasions, anticoagulants can present risks of accidental bleeding and hemorrhage or can delay emergency surgery. A newly completed phase III clinical study demonstrates the safety and efficacy of idarucizumab, a novel therapy that acts as an antidote to the blood thinner dabigatran.

"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," says first and corresponding author Charles Pollack, M.D., Professor of Emergency Medicine at Sidney Kimmel Medical College of Thomas Jefferson University. Dr. Pollack also serves as Associate Provost 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 results of the RE-VERSE AD clinical trial were published in The New England Journal of Medicine on July 11.

The study enrolled 503 patients taking dabigatran in 39 countries between 2014 and 2016, who had an urgent medical need to reverse the blood thinner. Patients were grouped by those who had uncontrolled bleeding or hemorrhage and those who required emergency surgery that could not be safely performed under anticoagulation. All patients received one dose of five grams of idarucizumab; only nine received a second dose. The researchers checked the blood for various measures of clotting ability before the reversal agent was administered and then at six time points afterwards to assess the therapy's speed and efficacy.

Idarucizumab was able to return patients to normal clotting function within minutes of administration (the first tested time point was between 10-30 minutes after therapy was given). The researchers saw that in patients with uncontrolled bleeding, idarucizumab was able to stop the bleeding within a median of 2.5 hours. Those requiring surgery were able to begin the procedure at a median of 1.6 hours.

The therapy, idarucizumab, from Boehringer Ingelheim Pharmaceuticals, is made from an antibody segment that functions by binding tightly and specifically to dabigatran and preventing the anticoagulant from working. As such, the therapy is only an effective antidote to dabigatran and not other anticoagulants.

Interim results of this study were published in 2015 and included the analysis of results from 90 patients. Based on those results and consistent findings from pre-clinical studies, the US Food and Drug Administration and the European Medicines Agency both granted approval for use of the drug in emergency settings. The current study confirms and strengthens the interim findings.

"For the first time we have the ability to turn off oral anticoagulation like a light switch," says Dr. Pollack. "In the past, we haven't had the ability to do that."

Pollack CV Jr, Reilly PA, Eikelboom J, Glund S, Verhamme P, Bernstein RA, Dubiel R, Huisman MV, Hylek EM, Kamphuisen PW, Kreuzer J, Levy JH, Sellke FW, Stangier J, Steiner T, Wang B, Kam CW, Weitz JI.
Idarucizumab for Dabigatran Reversal.
N Engl J Med. 2015 Aug 6;373(6):511-20. doi: 10.1056/NEJMoa1502000.

Most Popular Now

Novartis confirms 5 year data for first and only f…

Novartis, a global leader in Immunology & Dermatology, confirmed today positive 5 year efficacy and safety results for Cosentyx® from a Phase III long-term extension stud...

Researchers develop microneedle patch for flu vacc…

A National Institutes of Health-funded study led by a team at the Georgia Institute of Technology and Emory University has shown that an influenza vaccine can produce rob...

Jardiance® (empagliflozin) analysis reinforces est…

An analysis of pooled safety data from 15 studies plus 4 extension studies involving more than 12,500 adults with type 2 diabetes demonstrated treatment with Jardiance® (...

Alzheimer's and Parkinson's spurred by same enzyme

Alzheimer's disease and Parkinson's disease are not the same. They affect different regions of the brain and have distinct genetic and environmental risk factors. But at ...

Researchers publish new findings on influence of h…

Poor diet is associated with 80% of colorectal cancer cases, but the exact pathways by which diet leads to cancer are not known. In a newly published study, Cleveland Cli...

Merck awards €1.25 million to research projects th…

Merck, a leading science and technology company, today announced its commitment to award €1.25 million to research projects in the field of fertility, supporting the adva...

FDA tackles drug competition to improve patient ac…

Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower...

Trials show unique stem cells a potential asthma t…

A study led by scientists at Monash University has shown that a new therapy developed through stem cell technology holds promise as a treatment for chronic asthma. The Mo...

Roche acquires mySugr to form a leading open platf…

Roche (SIX: RO, ROG; OTCQX: RHHBY) and mySugr have signed an agreement under which Roche acquired all shares of mySugr GmbH. Counting more than one million users globally...

Older Americans don't get - or seek - enough help …

The majority of Americans over age 50 take two or more prescription medicines to prevent or treat health problems, and many of them say the cost weighs on their budget, a...

Novartis CAR-T cell therapy CTL019 unanimously (10…

Novartis announced today that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) unanimously (10-0) recommended approval of CTL019 (tisag...

New brain cancer drug targets revealed

Researchers from Case Western Reserve University School of Medicine and The Cleveland Clinic designed a way to screen brain tumor cells and identify potential drug target...

Pharmaceutical Companies

[ A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Z ]