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November 14, 2023
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In AF hospitalization, more than 10% of DOAC doses off-label after discharge

Fact checked byRichard Smith
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Key takeaways:

  • Among patients hospitalized with atrial fibrillation who were discharged with a direct oral anticoagulant, more than 10% were given an off-label dose.
  • The rate of off-label dosing decreased over time.

PHILADELPHIA — Among patients hospitalized with atrial fibrillation discharged on a direct oral anticoagulant, more than 10% received an off-label dose, researchers reported at the American Heart Association Scientific Sessions.

“Prior work has shown substantial off-label direct oral anticoagulant (DOAC) use, or use of DOAC at doses that may result in excess bleeding risk or below optimal stroke protection, in the outpatient setting,” Amneet Sandhu, MD, MSc, assistant professor of medicine at the University of Colorado School of Medicine, Anschutz Medical Campus, told Healio. “We were interested in evaluating the use of DOACs in inpatients, specifically those hospitalized for atrial fibrillation. Inpatient hospitalizations represent critical periods that may lead to changes in health state, warranting adjustment in DOAC dosing.”

Graphical depiction of data presented in article
Among patients hospitalized with atrial fibrillation who were discharged with a direct oral anticoagulant, more than 10% were given an off-label dose.
Data were derived from Sandhu A, et al. Abstract Su3235. Presented at: American Heart Association Scientific Sessions; Nov. 11-13, 2023; Philadelphia.

Sandhu and colleagues analyzed 22,470 patients included in the Get With the Guidelines–Atrial Fibrillation Registry (mean age, 70.1 years; 48.1% women; 82.5% white) who were hospitalized for AF and discharged on a DOAC for stroke prevention from 2014 to March 2020. Among the cohort, 66% were discharged on apixaban (Eliquis, Bristol Myers Squibb/Pfizer), 29% on rivaroxaban (Xarelto, Janssen/Bayer) and 5% on dabigatran (Pradaxa, Boehringer Ingelheim).

The results were simultaneously published in Circulation: Cardiovascular Quality and Outcomes.

The rate of off-label dosing was 11.2%, with 8.9% of patients underdosed and 2.3% overdosed.

Factors associated with off-label dosing were age (OR for underdosing per 1-year increase = 1.06; 95% CI, 1.06-1.07; OR for overdosing per 1-year increase = 1.07; 95% CI, 1.06-1.09), dialysis dependence (OR for underdosing = 5.5; 95% CI, 3.76-8.05; OR for overdosing = 5.47; 95% CI, 2.74-10.88), female sex (OR for overdosing = 0.79; 95% CI, 0.63-0.99) and weight (OR for overdosing per 1-kg increase = 0.96; 95% CI, 0.95-1), according to the researchers.

The adjusted median ORs across hospitals were 1.45 (95% CI, 1.34-1.65) for off-label dosing, 1.52 (95% CI, 1.39-1.76) for underdosing and 1.32 (95% CI, 1.2-1.84) for overdosing, suggesting much hospital-level variation, the researchers found.

Amneet Sandhu

“On a positive note, over the study period, the rate of guideline-recommended DOAC dosing increased, with a corresponding decline in under and overdosing,” Sandhu told Healio. Recommended dosing rose from 81.9% to 90.9% (P for trend < .0001), whereas underdosing declined from 14.4% to 6.6% (P for trend < .0001) and overdosing declined from 3.8% to 2.5%; P for trend = .001).

“The results suggest continued opportunity to improve the use of DOAC, particularly among those requiring hospitalization for atrial fibrillation,” Sandhu told Healio. “Future interventions to improve this gap could include continued development of team-based, integrated clinical care pathways including pharmacy, nursing, hospital medicine and cardiology; enhanced clinical decision support with automated dosing checks accounting for at-risk patient profiles identified as part of this work; and consideration of close outpatient follow-up attentive to the post-discharge DOAC dosing for at-risk patients.”

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