In final guidance published today (March 15), the UK drug watchdog the National Institute of Health and Clinical Excellence (NICE) has recommended Pradaxa (dabigatran), from independent German drug major Boehringer Ingelheim, as an option for the prevention of stroke and systemic embolism in people with atrial fibrillation.
The guidance, which confirms an earlier draft positive opinion (The Pharma Letter November 1, 2011) also recommends that the decision about whether to start treatment with dabigatran should be made after an informed discussion about the risks and benefits of dabigatran compared with warfarin, and in light of a person’s current level of international normalized ratio (INR) control if they are already taking warfarin. Publication of the final guidance follows the dismissal on all points of an appeal against the draft guidance.
Benefits over warfarin
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