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Dabigatran ‘as good as warfarin’ claim authors of ‘real-world’ study

Experience with dabigatran in ‘real-world’ practice in the first year after the new anticoagulant was approved in Denmark suggests it is as effective as warfarin for stroke prevention in patients with atrial fibrillation, without increasing the risk of bleeding or myocardial infarction.  

The study

Researchers analysed data for previously anticoagulant-naive patients with atrial fibrillation who were identified from the national registries. The team included 4,978 patients who were initiated on dabigatran treatment after it was formally approved in August 2011, and matched them using propensity score models in a 1:2 ratio with 8,936 patients who were treated with warfarin. Patients were followed up for a mean of 10.5 months.

The findings

Rates of stroke and systemic embolism were similar in the dabigatran and warfarin groups in both adjusted and unadjusted analyses and at both the 110 mg and 150 mg doses of dabigatran. Major bleeding was also comparable between groups at both doses of dabigatran. Mortality was significantly lower with dabigatran than with warfarin, with a 21% lower adjusted risk at the 110 mg dabigatran dose and a 43% lower adjusted risk at the 150 mg dose.

Intracranial bleeding was also significantly lower among dabigatran treated patients, with 76% and 92% lower adjusted risks at the higher and lower doses, respectively, although the authors point out that the incidence of intracranial bleeding overall was very low. Similarly, myocardial infarction rates were low overall and significantly lower with both doses of dabigatran, while pulmonary embolism also occurred less frequently in both dabigatran groups than in the warfarin group.

What this means for GPs

The researchers say their findings provide reassurance that dabigatran use in ‘everyday clinical practice’ is effective and not associated with excess bleeding or myocardial infarction risks. They write: ‘Efficacy in terms of stroke and systemic embolism was similar between warfarin and dabigatran (both doses)… The previous concerns about an excess of bleeding events or myocardial infarction amongst dabigatran treated patients were not evident.’

Expert comment

Professor Jonathan Mant, professor of primary care research at the University of Cambridge: ‘It is interesting that the absolute rates of bleeding on dabigatran were comparable to what was seen in the RE-LY trial, showing that the RE-LY trial’s population was not atypical of the population of patients – at least in Denmark – in which the drug is being used. It provides reassurance that the genuine benefits of dabigatran that were seen in the trial will translate into clinical practice.’

J Am Coll Cardiol 2013, online 10 April


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