The results from an independent retrospective comparative study, published in the American Journal of Medicine, have shown 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.
Recently, the Summary of Product Characteristics ( SmPC ) for Dabigatran in the EU ( European Union ) 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.
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 less than 0.001 [ Rivaroxaban, Apixaban ] ), intracranial haemorrhage ( 35-62% reduction; P less than 0.001 [ each NOAC ] ), and mortality ( 19-34% reduction; P less than 0.001 [ each NOAC ] ).
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.
Overall, researchers concluded that among the NOACs, Apixaban and Dabigatran had a more favourable benefit-harm profile than Rivaroxaban.
The 2019 study was carried out by independent researchers including David J. Graham, and funded by US Food and Drug Administration ( FDA ).
The retrospective, propensity-matched study analysed data from NVAF patients ( greater than or equal to 65 years old ) enrolled in US Medicare between 2010 and 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 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 ( greater than or equal to 65 years old ) initiating Dabigatran or Warfarin for the treatment of nonvalvular atrial fibrillation, who were enrolled in US Medicare between 2010 and 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.
Source: Boehringer Ingelheim, 2019