Pharmaceutical Business review

Dabigatran etexilate 150mg superior to warfarin in stroke prevention: Boehringer Ingelheim

RE-LY is a PROBE (prospective, randomised, open-label with blinded endpoint evaluation), designed to compare two fixed doses of the oral direct thrombin inhibitor dabigatran (110mg and 150mg bid) each administered in a blinded manner, with open label warfarin.

The reduction of stroke rates with dabigatran etexilate 150mg bid compared to well-controlled warfarin across all CHA2DS2VASc stroke risk groups were consistent with the overall RE-LY trial conclusions, which established the superiority of dabigatran etexilate 150mg bid versus well-controlled warfarin.

Dabigatran etexilate 150mg bid offers improved efficacy versus well-controlled warfarin (median TTR = 67%) for the prevention of stroke irrespective of the type of AF (paroxysmal, persistent, permanent), consistent with the overall RE-LY trial conclusions [as indicated by the p-value for interaction=0.16].

Uppsala University Hospital Jonas Oldgren said continuing on from previous RE-LY sub-group analyses, these data provide further evidence supporting dabigatran etexilate as an attractive alternative for stroke prevention in non-valvular AF across a wide range of patients and with different types of AF (paroxysmal to permanent).

"The availability of two dose strengths of dabigatran etexilate provides the opportunity to facilitate careful attention of individual patient characteristics," Oldgren said.