Dabigatran continues to be safe, useful in NVAF patients during idarucizumab era

Even after the dabigatran-specific reversal agent idarucizumab has been made available, dabigatran continues to be safe and well-tolerated for stroke and systemic embolism prevention in patients with nonvalvular atrial fibrillation (NVAF), reports a recent Japan study.

“Treatment outcomes have not changed since the availability of idarucizumab,” the researchers said. “[T]reatment guidelines for anticoagulation use in NVAF have been updated based on emerging clinical evidence, accounting for differences in patient characteristics, and making dabigatran a preference for distinct patient populations.”

The current analysis included 5,436 patients, of whom 3,516 and 1,898 were taking 110 mg and 150 mg of dabigatran twice-daily, respectively; the remaining 22 patients were given other dosing regimens. Follow-up lasted for an average of 287 days. Outcomes of interest included the incidences of bleeding, myocardial infarction, stroke, transient ischaemic attack, and death.

Such outcomes occurred at relatively low frequencies over the entire study duration, with annual rates mostly staying <2 percent. Only gastrointestinal disorders other than bleeding (7.9 percent) and nonmajor bleeding (3.8 percent) developed at rates higher than 2 percent.

Only 12 patients ultimately needed idarucizumab treatment, most commonly for cerebral bleeding (n=4) or cardiac issues (n=6). One patient died after idarucizumab treatment, due to haemorrhagic stroke with carotid artery dissection. Fifty-one patients died during the study.

In terms of safety, 10.7 percent (n=581) of patients developed adverse drug reactions, most of which were gastrointestinal, laboratory abnormalities, and renal and urinary in nature.