BI presents long-term Pradaxa data at AHA
German drug major Boehringer Ingleheim presented long-term data for its Pradaxa (dabigatran etexilate) in the prevention of thromboembolic events in patients with recurrent, persistent and chronic atrial fibrillation at the annual congress of the American Heart Association in New Orleans.
The study was an open-label extension of the PETRO trial and included 361 patients with AF and at least one other stroke risk factor who were receiving Pradaxa. Subjects have been followed for an average of 29 months, with the maximum follow-up being 51 months.
The PETRO and PETRO-Ex studies showed that thromboembolic event rates were low with dabigatran etexilate doses of 150mg and 300mg twice daily. Major bleeding was more frequent with the 300mg dose, but no significant liver function abnormalities were noted.
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