Dabigatran prescribing information is updated

June 22, 2012

Label prescribing information for dabigatran (Pradaxa, Boehringer Ingelheim) capsules has been updated to affirm that the 150-mg twice-daily dose is superior to warfarin in reducing ischemic and hemorrhagic strokes in patients with nonvalvular atrial fibrillation.

Label prescribing information for dabigatran (Pradaxa, Boehringer Ingelheim) capsules has been updated to affirm that the 150-mg twice-daily dose is superior to warfarin in reducing ischemic and hemorrhagic strokes in patients with nonvalvular atrial fibrillation (NVAF).

“The inclusion of specific wording about the superior reduction in ischemic and hemorrhagic stroke provided with Pradaxa over warfarin in the prescribing information is important in defining the benefit it provides when physicians are considering treatment options for patients with nonvalvular atrial fibrillation,” John Smith, MD, PhD, senior vice president for clinical development and medical affairs, Boehringer Ingelheim, told Formulary in an email.

Ischemic stroke accounts for at least 80% of all strokes, he said, so dabigatran is an important treatment option for many patients with NVAF because it is the only treatment compared to warfarin that provides a superior reduction in ischemic and hemorrhagic stroke, which is the main goal of anticoagulation treatment.

The update is based on the results of the Randomized Evaluation of Long-term anticoagulant therapY (RE-LY) trial - a prospective, multicenter, multinational, randomized, parallel-group trial - that compared 2 blinded doses of dabigatran (110 mg and 150 mg) to open-label warfarin adjusted locally to an international normalized ratio of 2.0 to 3.0 in 18,000 patients with NVAF.

Data from the trial demonstrated that a 150-mg twice-daily dose of dabigatran was superior in reducing ischemic and hemorrhagic stroke compared to warfarin in patients with NVAF. In addition, the incidence of intracranial bleeding was 59% lower with dabigatran 150 mg compared with warfarin.

The investigators also noted that the risk of major bleeds was similar to the 150-mg dabigatran dose and warfarin across major subgroups, with the exception of age. There was a trend toward a higher incidence of major bleeding for patients ≥75 years of age with dabigatran 150 mg. There also were higher rates of major gastrointestinal (GI) bleeding and total GI bleeding with dabigatran 150 mg compared with warfarin.

Boehringer Ingelheim noted in its statement that the company is focused on patient safety and committed to investigating dabigatran further through such studies as the currently on-going long-term safety study RELY-ABLE, which will be presented later this year. The company also says it has recently launched a phase 2 of the GLORIA-AF patient registry, which is designed to better characterize the use of antithrombotic treatments to reduce the risk of stroke in patients with NVAF.

Dabigatran is indicated to reduce the risk of stroke and systemic embolism in patients with NVAF.