13 Sep The GLORIA-AF Registry: Two Year Follow Up of Dabigatran for Non-Valvular A Fib Reported
MedicalResearch.com Interview with:
Menno Huisman, MD, PhD
Department of Medicine
Leiden University Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: GLORIA™-AF is one of the largest ongoing global registry programs examining the use of oral antithrombotic agents in real-world clinical practice. The program is designed to characterize the population of newly diagnosed patients with non-valvular atrial fibrillation (NVAF) at risk for stroke, and to study patterns, predictors and outcomes of different regimens for stroke prevention.
At the ESC Congress 2016, we presented the first Phase II results of GLORIA-AF from approximately 3,000 NVAF patients, which showed that treatment with PRADAXA was associated with low incidences of stroke, major bleeding and life threatening bleeding. Less than 1% of PRADAXA-treated patients experienced a stroke over two years (0.63%). Major bleeding occurred in 1.12% of PRADAXA-treated patients and 0.54% experienced a life-threatening bleed.
MedicalResearch.com: What should readers take away from your report?
Response: The data from GLORIA-AF add to the extensive body of data supporting the safety and effectiveness profile of PRADAXA for stroke risk reduction and are consistent with data seen in recently published studies assessing anticoagulant use in everyday clinical practice.
Real-world data complement data from randomized controlled clinical trials by offering additional safety and effectiveness insights from larger, more diverse patient populations with the co-morbidities encountered in various medical settings.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Two-years of follow up are planned for patients enrolled in Phase II of the GLORIA-AF study. This registry program will continue documenting patient characteristics, clinical usage and patient outcomes of anticoagulation in up to 56,000 NVAF patients in 2,200 sites and more than 50 countries throughout the world.
MedicalResearch.com: Is there anything else you would like to add?
Response: This is the first global, prospective, observational study describing the use of dabigatran etexilate in a broad NVAF patient population with 2 years of follow up information. The GLORIA-AF Registry will help provide important insights into the use, the effectiveness and safety of dabigatran etexilate in clinical practice settings.
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2016 ESC abstract:
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