Boehringer Ingelheim has announced in a company release the enrolment of the 10,000th patient with atrial fibrillation into GLORIA-AF, one of the largest atrial fibrillation registry programmes currently running worldwide. GLORIA-AF is a global registry on long-term oral antithrombotic treatment in patients with atrial fibrillation.
The registry will provide important information from everyday clinical practice on antithrombotic prescribing patterns and patient outcomes. Additionally, the registry is expected to provide valuable insight into how antithrombotic therapy can be further optimised to ensure patients with atrial fibrillation receive the best possible protection from a potentially disabling or deadly stroke. The innovative three-phase design of GLORIA-AF, published in the March issue of the American Heart Journal, will help to collect useful data on the effectiveness and safety of Pradaxa (dabigatran etexilate) versus warfarin and allow for the assessment of changes in prescribing patterns of antithrombotic therapies over time and across different regions of the world.
The GLORIA-AF registry programme has been designed to increase understanding of patient characteristics influencing choice of antithrombotic treatment, such as comorbidities and concurrent medications. GLORIA-AF will involve up to 56,000 patients newly diagnosed with atrial fibrillation at risk of stroke from nearly 50 countries worldwide. The registry programme will report patient outcome data that will assist in the evaluation of how antithrombotic therapies are used in the real world for the prevention of atrial fibrillation-related stroke.
“The introduction of new antithrombotics has changed prescribing patterns for stroke prevention in atrial fibrillation worldwide,” says Menno Huisman, professor of medicine at Leiden University Medical Center, Department of Thrombosis and Haemostasis, The Netherlands, and chair of the GLORIA-AF registry programme. “Large registries such as GLORIA-AF provide physicians with invaluable insights from outside the context of clinical trials. The knowledge that will be gained from GLORIA-AF will help physicians to choose the best possible treatment for their patients with atrial fibrillation to ensure effective stroke prevention.”
GLORIA-AF adopted a novel three-phase design. The registry programme is run in different phases, with useful information being collected to assess changes in prescribing patterns of antithrombotic therapies over time and across different regions of the world. The knowledge that will be shared throughout the registry programme will advance the management of atrial fibrillation in clinical practice.
- Phase I was undertaken to collect information on antithrombotic prescribing patterns prior to the approval of novel oral anticoagulants (NOACs) in many countries worldwide, enrolling patients from May 2011 to January 2013
- Phase II, which began after the approval of the first novel oral anticoagulant Pradaxa in November 2011, collects data on the safety of the treatment as well as the baseline characteristics of patients treated with Pradaxa or warfarin
- Phase III starts when there is sufficient overlap of patient characteristics between Pradaxa and warfarin treatment groups. Phase III will follow patients for three years to evaluate the effectiveness and safety of Pradaxa versus warfarin using patient outcome data. Information regarding the overall safety and effectiveness of other antithrombotic treatments will also be collected
To mirror the real-world setting, GLORIA-AF will include patients newly diagnosed with AF from multiple clinical settings including general practices, specialist offices, community and university hospitals, outpatient care centres and anticoagulation clinics. Knowledge will be gained from patients treated with a variety of therapies including warfarin and NOACs, as recommended in treatment guidelines for protection against the devastating consequences of AF-related stroke. Additionally data will be collected from patients prescribed acetylsalicylic acid (ASA) or no antithrombotic treatment.
Patient enrolment into the registry has commenced in all major regions of the world including Europe, North America, Latin America and Asia with the first global results expected to be announced in the first half of 2014.