Favorable safety profile of Pradaxa® (dabigatran etexilate) confirmed in large prospective real-world analysis
Complete Phase II results from the prospective GLORIA™-AF registry in dabigatran patients presented as a late-breaker at the EHRA 2018, the annual congress of the European Heart Rhythm Association (EHRA)[1]
Low rates of major bleeding and stroke observed for dabigatran patients[1]
Long-term safety data[1,2] highly consistent with other available real-world evidence and randomised clinical trials
“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™-AF Steering Committee. “The results from the second phase of GLORIA™-AF underline the safety and effectiveness of dabigatran, which is reassuring for physicians treating patients with atrial fibrillation.”
In an additional analysis from GLORIATM-AF[2] 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™,[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™-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]
Please click on the link for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/EHRA-Congress-2018
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2021년 9월 10일 15:15
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2021년 3월 2일 15:05