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Evaluating Prescribing Practices of Apixaban in the Elderly
Abstract
OBJECTIVE: The aim of this study was to evaluate prescribing practices for elderly patients started on apixaban in multiple practice settings.
DESIGN: Retrospective, chart review.
SETTING: One outpatient and three inpatient settings in Arizona and Massachusetts.
PATIENT, PARTICIPANTS: Patients who received a new order for apixaban between July 1, 2015, and December 31, 2016. Inclusion criteria included adults 65 years of age and older who were receiving apixaban for atrial fibrillation or venous thromboembolism (VTE) at a current treatment dose.
There were 1,045 patients included, the average age was 78 years, 52% were male, and 90% had atrial fibrillation.
MAIN OUTCOME MEASURE: Appropriate prescribing of apixaban based on Food and Drug Administration (FDA)-labeling (age, weight, serum creatinine).
RESULTS: Six patients who were on hemodialysis were excluded from the analysis, leaving 1,039 patients to be analyzed. 16.2% (168/1,039) of patients had an incorrect dose of apixaban prescribed based on their indication. Of those, 75% (126/168) were taking the medication for atrial fibrillation and 25% (42/168) for VTE. For those with atrial fibrillation (n = 126), the majority of inappropriate orders resulted from doses that were lower than indicated (113/126).
CONCLUSION: This research suggests that elderly patients may receive inappropriately lower doses of apixaban than indicated, which may decrease the effectiveness of the medication. This research supports the fact that pharmacists can play a vital role in anticoagulation stewardship by verifying apixaban doses for accuracy.
... 27 Pogge shared that in her clinical practice, she performed a chart review to determine appropriate dosing and found approximately 16% of patients on apixaban were underdosed. 28 She used this data to reiterate the importance of an anticoagulation clinic. Haimowitz shared that sometimes providers might not think underdosing is a problem in their practice until they are shown the data and reviews like this, which create awareness of the issue. ...
Beyond Warfarin: How does the
American Geriatric Society Beers
Criteria® Impact Appropriate Use
of Anticoagulants in Older Adults?
... Also, few clinical trials have been carried out to assess its efficacy and safety in morbidly obese patients in comparison to warfarin [8]. Interestingly, apixaban has been inappropriately prescribed, dispensed, and administered to morbidly obese patients who otherwise would not have been ideal candidates to receive apixaban [9]. Recent published studies found that high serum creatinine level and inappropriate use of NSAIDs may significantly modulate the efficacy and safety of apixaban in obese patients [10,11]. ...
... Also, few clinical trials have been carried out to assess its efficacy and safety in morbidly obese patients in comparison to warfarin [8]. Interestingly, apixaban has been inappropriately prescribed, dispensed, and administered to morbidly obese patients who otherwise would not have been ideal candidates to receive apixaban [9]. Recently published studies found that high serum creatinine levels and inappropriate use of NSAIDs may significantly modulate the efficacy and safety of apixaban in obese patients [10][11]. ...
This study was conducted to evaluate the efficacy and safety of apixaban versus warfarin in morbidly obese patients. A total of 250 morbidly obese patients with a body mass index (BMI) higher than 40 kg/m2 or a body weight higher than 120 kg who were on anticoagulation therapy with either apixaban or warfarin for over one month were included in the study. This retrospective cohort, multicenter study was executed using the medical records of 125 morbidly obese patients treated with apixaban, while patients on warfarin were selected using a systemic random sampling to match the sample size of the apixaban group. There was no significant difference between apixaban and warfarin in the development of thromboembolic events and major bleeding. However, incidences of minor bleeding significantly decreased in the apixaban group compared to patients treated with warfarin. This difference was overcome by controlling serum creatinine and nonsteroidal anti-inflammatory drugs (NSAIDs). In conclusion, apixaban efficacy and safety are nearly the same as that of warfarin in morbidly obese patients with a lower incidence of minor bleeding with apixaban. Controlling serum creatinine and NSAIDs use may improve warfarin safety and decrease its complications.
Background
Apixaban is commonly used to prevent stroke in older adults with nonvalvular atrial fibrillation (AF). Although its package insert has specific dose reduction criteria, providers may dose reduce outside of these parameters based on clinical scenarios.
Objective
The primary objective was to determine the incidence of apixaban off-label reduced dosing, while secondarily determining the safety and efficacy outcomes associated with such dosing.
Methods
A retrospective analysis of patients aged 65 and older with orders for apixaban for AF was institutional review board (IRB)-approved and conducted across 3 academic medical centers. Patients receiving off-label reduced-dose apixaban (ie, “underdosed”) were matched to a cohort of patients dosed according to the package insert at the standard dosing (5 mg twice daily) using stratified random sampling. Secondary outcomes included 1-year incidence of major bleeding, clinically relevant non-major bleeding (CRNMB), stroke or transient ischemic attack (TIA), and mortality. The Fisher exact tests were used to compare between-group differences.
Results
Of the 1172 patients meeting initial inclusion criteria, 201 (17%) were dosed off-label, with 175 (15%) “underdosed.” The 147 “underdosed” patients with documented follow-up were matched with 139 patients receiving standard Food and Drug Administration (FDA)-labeled dosing. There were no significant differences in incidence of stroke (2.7% vs 2.2%), major bleeding (0% vs 0.7%), and CRNMB (2.7% vs 1.4%) in the off-label reduced dosing versus standard dosing groups. All-cause mortality was higher in the off-label reduced-dose group (16 [10.9%] vs 2 [1.4%], P < 0.05).
Conclusion and Relevance
Older adults with nonvalvular AF are commonly prescribed lower-than-recommended doses of apixaban. However, no significant association was found between empiric off-label reduced dosing and stroke or bleeding outcomes.
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