Researchers at Northwestern Memorial Hospital (NMH; Chicago, IL, USA), University Hospital Leuven (UZ Leuven; Belgium), and other institutions participating in the Reversal Effects of idarucizumab in patients on Active Dabigatran (RE-VERSE AD) study reported the results of an interim analysis, showing that idarucizumab effectively reversed dabigatran's anticoagulant effects in brain hemorrhage patients. Blood tests revealed that in all 18 patients who received two 2.5-gram of idarucizumab infusions in a 15-minute period, dabigatran's blood-thinning effect was 100% reversed.

 

The new results are part of the large on-going phase III study that is testing idarucizumab in a range of patients on dabigatran and who have dangerous bleeding or need urgent surgery or other procedures that carry serious bleeding risks. Before idarucizumab was available, these patients, when in need of emergency surgery, were given purified clotting factors, which could induce dangerous blood clot formation. The study was presented at the American Stroke Association International Stroke Conference, held during February 2016 in Los Angeles (CA, USA). 

 

“This is definitely good news. Idarucizumab rapidly and completely reverses the effect of dabigatran in patients with brain hemorrhage. Once the dabigatran is reversed, we can focus on taking care of the patient without worrying about the blood thinner,” said lead author and study presenter Richard Bernstein, MD, PhD, director of the stroke program at NMH. “Idarucizumab gets rid of the dabigatran, but doesn't seem to carry with it any tendency to increase clotting. This should make perioperative management easier and safer.” 

 

“The biggest problem we face in preventing stroke in patients with atrial fibrillation is that almost half of patients don't take any blood thinner at all,” continued Dr. Bernstein. “I see the biggest impact of idarucizumab as providing reassurance to patients that if bleeding while taking dabigatran does occur, we can quickly reverse the dabigatran. This reassurance could lead to more strokes prevented by increasing the use of an effective blood thinner.”

 

Dabigatran is a novel oral anticoagulant (NOAC) that works by directly inhibiting thrombin; it was developed by the Boehringer Ingelheim (Germany) and is marketed as Pradaxa. Until the introduction of NOACs, warfarin had been one of the only treatment options for long-term anticoagulation of patients with conditions that require chronic anticoagulation. The major benefit of the NOAC anticoagulants is that they do not require strict and frequent laboratory monitoring, dosing adjustments, or dietary restrictions, and incur fewer drug interactions than warfarin.