The Effect of Dabigatran Plasma Concentrations and Patient Characteristics on the Frequency of Ischemic Stroke and Major Bleeding in Atrial Fibrillation Patients

“The paper by Reilly et al. suggested that up to 20% of patients using the 110 and 150 mg twice daily dosing will fall outside of the optimal concentration range of 35 to 300 ng/ml. Recently unsealed court documents reveal internal pharmaceutical correspondence that suppressed important data regarding dabigatran therapy for patients with atrial fibrillation.”

“Boehringer Ingelheim, the maker of dabigatran, has failed to share with regulators information about the potential benefits of monitoring anticoagulant activity and adjusting the dose to make sure the drug is working as safely and effectively as possible. The company also withheld analyses that calculated how many major bleeds dose adjustment could prevent.”

“Optimally used (=titrated) dabigatran has the potential to provide patients an even better efficacy and safety profile than fixed dose dabigatran and also a better safety and efficacy profile than a matched warfarin group.”