Pharmacy Daily | Pradaxa gets thumbs up

A NEW study presented at the 2012 American Heart Association annual meeting has added fuel to the push for Pradaxa to be PBS listed for patients with atrial fibrillation, with results supporting the long-term benefit and safety of the treatment. The double-blinded RELY-ABLE trial tracked 5,851 non-valvular atrial fibrillation patients taking Pradaxa for 2.3 years and found the rate of ischaemic stroke: 1.15% per year on dabigatran 150mg bd and 1.24% per year on 110mg bd. Other data showed incidence of hemorrhagic stroke: 0.13% per year on dabigatran 150mg bd and 0.14% per year on 110mg bd; as well as incidence of major bleeding: 3.74% per year on dabigatran 150mg bd and 2.99% per year on 110mg bd; and rate of intracranial bleeding: 0.33% per year on dabigatran 150mg bd and 0.25% per year on 110mg bd. “RELY-ABLE reveals reassuring rates of stroke and bleeding with both doses of dabigatran over a sustained period of treatment,” said Associate Professor John Amerena, Cardiologist from Geelong Hospital and RELY-ABLE investigator. “Most patients with non-valvular atrial fibrillation need life-long anticoagulant treatment to be protected from ischaemic stroke. The long-term data we now have for dabigatran is reassuring for both patients and prescribers,” Amerena added.

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