December 1, 2016Open Access

Off-Label Dosing of Non-Vitamin K Antagonist Oral Anticoagulants and Adverse Outcomes

Structured PICO

Does off-label dosing of NOACs increase the risk of adverse events in U.S. patients with atrial fibrillation?

Population

U.S. patients in the community with atrial fibrillation (from the ORBIT-AF II registry)

Intervention

Non-Vitamin K Antagonist Oral Anticoagulants (NOACs) dosed inconsistently with labeling (over- and underdosing)

Comparator

NOAC doses consistent with labeling

Outcome

Adverse eventssafety

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.

Abstract

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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Cite This Study

Steinberg et al. (Thu,) studied this question.

synapsesocial.com/papers/69d56dc675589c71d767d084 https://doi.org/https://doi.org/10.1016/j.jacc.2016.09.966

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