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Published on: February 26, 2013
Direct-Acting Oral Anticoagulants and Potential Inconsistencies with FDA-Approved Dosing for Non-Valvular Atrial
Bonnie DeLor1, Jon J Glover2, Timothy J Hartman2
1Pfizer Inc, 66 Hudson Blvd E, New York, NY, 10001, USA. bonnie.delor@pfizer.com.
Insights
Direct-acting oral anticoagulant (DOAC) dosing inconsistent with FDA labels was common in non-valvular atrial fibrillation (NVAF) patients. Inconsistent dosing varied by patient factors, prescriber, and healthcare system, highlighting a need for improved monitoring.
Area of Science:
- Pharmacology
- Clinical Pharmacy
- Cardiology
Background:
- Direct-acting oral anticoagulants (DOACs) are crucial for preventing stroke and embolism in non-valvular atrial fibrillation (NVAF).
- However, deviations from FDA-approved DOAC dosing guidelines are frequent and linked to adverse patient outcomes.
Purpose of the Study:
- To determine the prevalence of label-inconsistent DOAC dosing in ambulatory NVAF patients.
- To identify patient-specific variables associated with DOAC doses lower or higher than recommended.
Main Methods:
- A retrospective analysis of electronic health records from nine US healthcare systems was conducted.
- Data from adult NVAF patients receiving DOAC therapy in 2022 were analyzed.
- Multivariable regression identified factors associated with label-inconsistent DOAC dosing.
Main Results:
- Nearly 10% of 51,128 NVAF patients received label-inconsistent DOAC doses (6.8% lower, 3.0% higher).
- Factors like older age, renal impairment, hypertension, female sex, and higher weight were associated with inconsistent dosing.
- Dosing inconsistencies varied significantly by prescriber specialty and healthcare system.
Conclusions:
- DOAC dosing inconsistencies in NVAF patients are influenced by patient demographics, clinical status, prescriber type, and healthcare setting.
- Targeted interventions are needed to ensure appropriate DOAC dosing, particularly in vulnerable patient groups.
Background:
Direct-acting oral anticoagulants (DOACs) are recommended to reduce risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF). However, DOAC dosing inconsistent with FDA-approved product labels is common and associated with poor clinical outcomes.
Objectives:
Identify DOAC dosing inconsistent with FDA-approved product labels in ambulatory care patients with NVAF; identify variables associated with dosing lower and higher than label.
Design:
Retrospective analysis using electronic health records from nine US healthcare systems.
Patients:
Adults with NVAF receiving DOAC therapy in 2022.
Main Measures:
Rates of label-inconsistent dosing; multivariable regression analysis to identify demographic and clinical variables associated with dosing lower and higher than label.
Key Results:
Among 51,128 NVAF patients (56.1% male, 94.3% White, mean [SD] age 73.5 [10.5] years), 5008 (9.8%) were prescribed label-inconsistent doses of DOACs (6.8% lower and 3.0% higher than label). Age ≥ 75 years, renal impairment, and hypertension were significantly associated with inconsistent dosing both higher and lower than label. Female sex and higher weight were significantly associated with dosing lower than label, as were heart failure, vascular or liver disease, and bleeding history. Dosing higher than label was significantly associated with male sex, race (African American/Black), weight < 60 kg, and use of drugs with potential drug-drug interactions. When prescribed by primary care physicians, DOAC doses were 37% (95% CI, 27-49%) more likely to be lower than label and 30% (95% CI, 16-46%) more likely to be higher than label than when prescribed by cardiologists or electrophysiologists. Label-inconsistent dosing varied (6.7 to 15.8%) across participating systems.
Conclusions:
DOAC dosing inconsistent with label varied by demographics, clinical characteristics, prescriber specialty, and healthcare system, suggesting a need to monitor and assess dosing decisions in NVAF. Identification of variables associated with dosing inconsistencies may enable targeted interventions to ensure label-consistent dosing in vulnerable populations.
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