The results from an independent retrospective comparative study, published in January 2019 in the American Journal of Medicine, showed that dabigatran was associated with a more favourable benefit-harm profile than both warfarin and rivaroxaban. The study analysed a database of patients enrolled in US Medicare with non-valvular atrial fibrillation (NVAF) treated with either a standard dose of a non-vitamin K antagonist oral anticoagulants (NOAC, i.e. dabigatran, rivaroxaban or apixaban) or warfarin.(1)
Recently, the Summary of Product Characteristics (SmPC) for dabigatran in the EU was updated with information from the results of a previous large independent Medicare study, which was published in Circulation in 2015. In the study, dabigatran was associated with reduced risk of ischaemic stroke, intracranial haemorrhage and mortality and increased risk of gastrointestinal bleeding in elderly NVAF patients compared to warfarin. The risk of major bleeding was similar across both study drugs.(2)
According to the 2019 independent real-world study, compared to warfarin, each NOAC investigated was associated with reduced risk of thromboembolic stroke (20-29% reduction; P=0.002 [dabigatran], P<0.001 [rivaroxaban, apixaban]), intracranial haemorrhage (35-62% reduction; P<0.001 [each NOAC]), and mortality (19-34% reduction; P<0.001 [each NOAC]).(1)
The most recent study also compared the individual NOACs with each other. According to the results, both dabigatran and apixaban demonstrated decreased risks of intracranial haemorrhage, major extracranial bleeding, and death, compared with rivaroxaban.(1)
Overall, the authors concluded that among the NOACs, apixaban and dabigatran had a more favourable benefit-harm profile than rivaroxaban.(1)
"This independent study from 2019 is a positive reminder of dabigatran’s demonstrated safety profile, compared to both warfarin and rivaroxaban," said Dr Waheed Jamal, Corporate Vice President, Head of Cardiometabolic Medicine, Boehringer Ingelheim. "Also, it is quite unique that a non-interventional study based on a retrospective assessment of a specific database has been accepted by a Health Authority to be added to the product label. Both this and the new comparative data add further credibility to the body of evidence demonstrating the favourable safety and efficacy profile of Pradaxa® in its licensed indications."
The 2019 study was carried out by independent researchers including David J. Graham, MD, MPHm, and funded by US Food and Drug Administration (FDA). The retrospective, propensity-matched study analysed data from NVAF patients (≥ 65 years old) enrolled in US Medicare between Oct. 2010 and Sept. 2015. Only those initiating on warfarin (183,318) or standard US dose of dabigatran (86,198), rivaroxaban (106,389), or apixaban (73,039) were included.
The 2015 study was also carried out by independent researchers, led by David J. Graham, MD, MPHm, and was funded through an intra-agency agreement between the Centers for Medicare & Medicaid Services and the FDA. The retrospective study analysed data from NVAF patients (≥ 65 years old) initiating dabigatran or warfarin for the treatment of nonvalvular AF, who were enrolled in US Medicare between Oct. 2010 and Dec. 2012. Dabigatran users (67,207) were propensity score matched to warfarin users in a 1:1 ratio. Patients who had received prior treatment with a study medication or rivaroxaban or apixaban were excluded from the study.
About Boehringer Ingelheim
Improving the health and quality of life of patients is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2017, Boehringer Ingelheim achieved net sales of nearly 18.1 billion euros. R&D expenditure, exceeding three billion euros, corresponded to 17.0 per cent of net sales.
As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.
1 Graham DJ et al. Comparative stroke, bleeding, and mortality risks in older Medicare patients treated with oral anticoagulants for nonvalvular atrial fibrillation. Am J Med. 2019.
2 Graham DJ et al. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation. 2015.