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In addition to the statistically significant superiority of dabigatran 150 mg bid over warfarin, that dose was also significantly superior to the lower, 110 mg bid dose of dabigatran, as highlighted in the Figure.[96] This was a major consideration in the US FDA’s approval of the 150 mg bid but not the 110 mg bid dose; that is, they did not want to deprive patients of a dose that was clearly superior to either lower dose dabigatran or to warfarin.
Reiffel JA. Am J Med 2013; 126: 00-00.
[96] Connolly SJ, Ezekowitz MD, Yusuf S, et al; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009;361:1139-1151.