Label update for Pradaxa® (Dabigatran)

Boehringer Ingelheim has announced an update to the prescribing information of Pradaxa® (dabigatran etexilate mesylate) capsules.

The information has been updated to affirm that Pradaxa 150 mg twice daily was superior in reducing ischemic and hemorrhaging strokes relative to warfarin in patients with non-valvular atrial fibrillation (NVAF).

The update to the ‘clinical studies’ section is based on the results of the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial, a noninferiority trial comparing the use of dabigatran, at doses of 110 mg twice daily and 150 mg twice daily, with warfarin in more than 18,000 NVAF patients.

The results of RE-LY showed that Pradaxa 150 mg twice daily was superior in reducing ischemic and hemorrhagic stroke compared with warfarin in this patient population. The risk for major bleeds was similar across subgroups with the exception of age, where there was a trend towards a higher incidence of major bleeding with Pradaxa for patients aged 75 and older.

There were also higher rates of major and total gastrointestinal bleeding with Pradaxa 150 mg than warfarin, but there was a 59% lower incidence of intracranial bleeding with Pradaxa compared with warfarin.

“Pradaxa is an important treatment option for many patients with NVAF as 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,” said John Smith, senior vice president fro clinical development and medical affairs at Boehringer Ingelheim.

“The inclusion of specific wording about the superiority of Pradaxa over warfarin in the prescribing information is important in defining the benefit it provides when physicians are considering treatment options for this patient population.”

Boehringer Ingelheim says that it remains focused on patient safety and is committed to further investigating Pradaxa through research such as the long-term safety study RELY-ABLE (Long Term Multi-center Extension of Dabigatran Treatment in Patients With Atrial Fibrillation Who Completed RE-LY Trial), which will be presented later this year.

The company recently launched phase II 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. “It is important for physicians and patients to discuss the important clinical benefit of superior stroke risk reduction with Pradaxa versus warfarin when considering treatment options,” commented Greg Behar, president and CEO at Boehringer Indelheim.

By Nikki Withers