Why the study?
Does off-label dosing of NOACs increase the risk of adverse events in U.S. patients with atrial fibrillation?
Does off-label dosing of NOACs increase the risk of adverse events in U.S. patients with atrial fibrillation?
Off-label dosing of NOACs is common in community practice (almost 1 in 8 patients) and is associated with an increased risk of adverse clinical events.
Off-label NOAC dosing was associated with higher adverse events in AF; hypothesis-generating and should not yet change practice.
A significant minority (almost 1 in 8) of U.S. patients in the community received NOAC doses inconsistent with labeling. NOAC over- and underdosing are associated with increased risk for adverse events. (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II [ORBIT-AF II]; NCT01701817).
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Steinberg et al. (2016) studied this question.
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