Favorable safety profile of Pradaxa® (dabigatran etexilate) confirmed in large prospective real-world analysis

INGELHEIM, Germany–(BUSINESS WIRE)– New data from one of the largest prospective ongoing global studies examining the use of oral antithrombotics for stroke prevention in atrial fibrillation (AF) in clinical practice, GLORIA^TM-AF, were presented at the EHRA 2018, the annual congress of the European Heart Rhythm Association (EHRA).^1,2 The registry examined two-year safety and effectiveness outcomes of nearly 5,000 AF patients treated with dabigatran (marketed as Pradaxa^®). Results of the completed Phase II of GLORIA^TM-AF,¹ presented during the ‘Late-breaking science – Registries’ session, showed low rates of major bleeding (0.97%) and stroke (0.65%). These findings confirm the sustained safety and effectiveness of dabigatran and are highly consistent with the long-term safety profile observed in other real-world evidence, as well as in randomised clinical trials.

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“Long-term, ‘real-world’ data are important to cardiologists as they help build a bigger picture of how an antithrombotic medication works in daily clinical practice,” commented Gregory Y H Lip, MD, Co-Chair of the GLORIA^TM-AF Steering Committee. “The results from the second phase of GLORIA^TM-AF underline the safety and effectiveness of dabigatran, which is reassuring for physicians treating patients with atrial fibrillation.”

In an additional analysis from GLORIA^TM-AF² the safety of uninterrupted dabigatran for patients undergoing cardiovascular (CV) interventions was evaluated. The rates of major bleeding and stroke/ systemic embolism were very low, i.e. one major bleed and one systemic embolic event occurred in 412 CV interventions that were performed with uninterrupted dabigatran.

“From the first clinical trials such as RE-LY^® and RELY-ABLE^®, through to numerous real-world studies, both supported by and independent from Boehringer Ingelheim, we get an absolute, consistent picture of the favorable safety of dabigatran,” commented Professor Jörg Kreuzer, Vice President Medicine, Therapeutic Area Cardiovascular, Boehringer Ingelheim. “Recent clinical trials in specific settings like RE-CIRCUIT^TM,³ with dabigatran in AF patients undergoing cardio ablation, again demonstrated the superior safety of Pradaxa^® compared to standard-of-care. The prospective, long-term data for dabigatran from GLORIA^TM-AF now add one further piece to complete this picture with profound real-world evidence.”

AF is the most common cardiac rhythm disorder worldwide, with numbers expected to rise in the coming years.⁴ Overall, people diagnosed with AF have a five-fold increased risk of stroke,⁵ which occurs when a blood clot blocks a vessel in the brain. Each year three million patients suffer AF-related strokes.^6,7

~ENDS~

Please click on the link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/EHRA-Congress-2018

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