New Data Show High Adherence Rates with Pradaxa® (dabigatran etexilate mesylate) in NVAF Patients

Boehringer Ingelheim Pharmaceuticals, Inc. announced on Dec. 4, 2016, results from a new analysis of the GLORIA™-AF Registry Program, which showed that newly diagnosed non-valvular atrial fibrillation (NVAF) patients treated with Pradaxa® (dabigatran etexilate mesylate) had a 76.6 percent probability of remaining on treatment at one year and a 69.2 percent probability at two years. The results were presented on Dec. 4, 2016  at the American Society of Hematology (ASH) Annual Meeting in San Diego, CA.

“Patients with NVAF are at a five times greater risk for stroke, and the goal of anticoagulant therapy is to reduce this risk. It is critical for patients and physicians to understand the benefits of staying on prescribed treatment and the potential risks of discontinuing,” said Jonathan Halperin, M.D., the Robert and Harriet Heilbrunn Professor of Medicine at the Icahn School of Medicine at Mount Sinai, study author and member of the GLORIA-AF steering committee. “In general, nearly half of patients discontinue oral anticoagulant therapy after only a year, so it is promising to see high adherence rates with PRADAXA in this new analysis from the GLORIA-AF Registry.”

The analysis was based on real-world data from 2,937 PRADAXA patients receiving care at nearly 1,000 sites in 44 countries. Eighty-eight percent of the patients were considered at high risk for stroke (i.e., CHA2DS2-VASc score of 2 or higher), and many patients experienced other health conditions in addition to NVAF, including hypertension (78.9%), diabetes (22.7%) and heart failure (24.9%). Of patients who permanently discontinued treatment with PRADAXA, half (418/828) had switched to another oral anticoagulant by the second year of follow-up.

“Understanding how medicines are used in the real world, including factors that may influence patients to stop taking treatment, is essential to helping the community identify ways to improve patient outcomes,” said Sabine Luik, MD, senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “These results are encouraging and underscore that the majority of PRADAXA patients follow their treatment plan. The growing body of real-world data on PRADAXA, and the fact that it is the only novel oral anticoagulant with a specific reversal agent available, should offer healthcare providers, patients and caregivers added assurance in reducing stroke risk in NVAF patients.”

About GLORIA™-AF (Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation)
GLORIA™-AF is one of the largest worldwide registry programs to investigate the long-term use of oral antithrombotic therapies in reducing the risk of NVAF-related strokes in the clinical setting. The Registry examines physicians’ prescribing behaviors in treating NVAF, as well as the factors behind their prescribing decisions. The study is collecting long-term safety and effectiveness data on a range of antithrombotics, including warfarin, ASA (aspirin) and NOACs for stroke risk reduction in NVAF, as well as patient outcomes data.

The Registry Program will enroll up to 56,000 patients newly diagnosed with AF at risk of stroke from up to 2,200 sites in nearly 50 countries.

Please see full Prescribing Information, including boxed WARNING and Medication Guide.



SOURCE Boehringer Ingelheim Pharmaceuticals, Inc.

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