Study of Pradaxa (Boehringer) for Atrial Fibrillation shows positive safety profile and efficacy

New data from the RELY-ABLE study have provided additional support to the safety profile and efficacy of Pradaxa (dabigatran etexilate), from Boehringer, for stroke prevention in patients with nonvalvular Atrial Fibrillation (AF) over a period in excess of 2 years. The international multi-centre RELY-ABLE study followed 5,851 patients on dabigatran etexilate for a further 28 months after completion of the RE-LY trial. It examined the long-term benefits of the two treatment doses (110mg bid and 150mg bid) in an ongoing randomised and blinded approach. Results from RELY-ABLE show that the rates of ischaemic stroke are 1.15%/year on 150mg bid and 1.24%/year on 110mg bid. The incidence of haemorrhagic stroke is 0.13%/year on 150mg bid and 0.14%/year on 110mg bid and the incidence of major bleeding is 3.74%/year on 150mg bid and 2.99%/year on 110mg bid.

These rates indicate that dabigatran etexilate provides sustained benefits. Furthermore, both doses of dabigatran etexilate had a similar net clinical benefit and mortality rates. The safety profile of dabigatran etexilate was consistent with the findings from the RE-LY trial. Data was presented at the American Heart Association's (AHA) Scientific Sessions.