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.
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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.