Direct Oral Anticoagulants and Non-valvular Atrial Fibrillation: Compliance with Dose Level Guidelines in Patients Aged 80 Years and Over

Decaestecker, Marie Cavillon; Ferret, Laurie; Decaestecker, Kévin; Gautier, Sophie; Verdun, Stéphane; Tsogli, Essé Sylvestre

doi:10.1007/s40266-021-00883-1

Cited by 3 publications

(7 citation statements)

References 33 publications

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“…This is consistent with previous findings in the older adult patient population. 7,11,13,15 Off-label dose reduction of apixaban was not associated with a significantly increased risk for stroke, or decreased risk of CRNMB or major bleeding. This is consistent with the findings of the 2022 systematic review that was not limited to older adults.…”

Section: Discussionmentioning

confidence: 91%

“…Numerous studies have evaluated prescribing practices of apixaban in patients with nonvalvular AF and have reported the incidence of offlabel apixaban dose reductions (ie, "underdosing") to be between 8.1%-39%. [7][8][9][10][11][12][13][14][15][16][17][18][19] However, only 4 of these studies excluded patients younger than age 65, and none have explored the clinical impact of this underdosing practice in older adults specifically. 7,11,13,15 Several studies not limited to older adults have been conducted to examine the clinical impact of off-label dose reduction of apixaban in patients with AF, and a systematic review of these data was published in 2022.…”

Section: Introductionmentioning

confidence: 99%

“…[7][8][9][10][11][12][13][14][15][16][17][18][19] However, only 4 of these studies excluded patients younger than age 65, and none have explored the clinical impact of this underdosing practice in older adults specifically. 7,11,13,15 Several studies not limited to older adults have been conducted to examine the clinical impact of off-label dose reduction of apixaban in patients with AF, and a systematic review of these data was published in 2022. 20 The authors conducted a meta-analysis using data from 5 retrospective cohort studies (n = 46 521), which suggested that there was no difference in stroke and systemic embolism or major bleeding in patients who received off-label reduced-dose apixaban versus those who received it according to FDA labeling.…”

Section: Introductionmentioning

confidence: 99%

“…Numerous studies have evaluated prescribing practices of apixaban in patients with nonvalvular AF and have reported the incidence of off-label apixaban dose reductions (ie, “underdosing”) to be between 8.1%-39%. 7-19 However, only 4 of these studies excluded patients younger than age 65, and none have explored the clinical impact of this underdosing practice in older adults specifically. 7,11,13,15…”

Section: Introductionmentioning

confidence: 99%

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Off-Label Reduced Dose Apixaban in Older Adults With Atrial Fibrillation and Associated Outcomes

Campbell,

Pae,

Lee

et al. 2023

Ann Pharmacother

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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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Section: Discussionmentioning

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Off-Label Reduced Dose Apixaban in Older Adults With Atrial Fibrillation and Associated Outcomes

Campbell,

Pae,

Lee

et al. 2023

Ann Pharmacother

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“…et al, 2019). We believe that underdosing could have been caused by insufficient knowledge or lack of confidence in the appropriate dose ( Sato et al, 2018 ; Cavillon Decaestecker et al, 2021 ), or by fear of the prescribers of causing harm, such as bleeding, as women present higher frequency and severity of adverse drug reactions than men ( Tamargo et al, 2017 ; Fernández et al, 2020 ). We also think that prescribers might be more concerned for bleeding risk than for stroke risk, as overdosing was less frequent, and it might have been caused by insufficient knowledge of the criteria for dose reduction for each DOAC ( Sato et al, 2018 ; Cavillon Decaestecker et al, 2021 ).…”

Section: Discussionmentioning

confidence: 99%

Sex and gender differences in the use of oral anticoagulants for non-valvular atrial fibrillation: A population-based cohort study in primary health care in catalonia

Giner-Soriano

Prat-Vallverdú²,

Ouchi³

et al. 2023

Front. Pharmacol.

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Objectives: To describe the sex and gender differences in the treatment initiation and in the socio-demographic and clinical characteristics of all patients initiating an oral anticoagulant (OAC), and the sex and gender differences in prescribed doses and adherence and persistence to the treatment of those receiving direct oral anticoagulants (DOAC).Material and methods: Cohort study including patients with non-valvular atrial fibrillation (NVAF) who initiated OAC in 2011–2020. Data proceed from SIDIAP, Information System for Research in Primary Care, in Catalonia, Spain.Results: 123,250 people initiated OAC, 46.9% women and 53.1% men. Women were older and the clinical characteristics differed between genders. Women had higher risk of stroke than men at baseline, were more frequently underdosed with DOAC and discontinued the DOAC less frequently than men.Conclusion: We described the dose adequacy of patients receiving DOAC, finding a high frequency of underdosing, and significantly higher in women in comparison with men. Adherence was generally high, only with higher levels in women for rivaroxaban. Persistence during the first year of treatment was also high in general, being significantly more persistent women than men in the case of dabigatran and edoxaban. Dose inadequacy, lack of adherence and of persistence can result in less effective and safe treatments. It is necessary to conduct studies analysing sex and gender differences in health and disease.

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Retrospective Cross-sectional Analysis of Older Adults Living with Frailty and Anticoagulant Use for Atrial Fibrillation

et al. 2023

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Background Oral anticoagulation (OAC) is recommended for most individuals with atrial fibrillation (AF), including those who are frail. Based on previous literature, those who are frail may be less likely to be prescribed OAC, and up to one-third may receive an inappropriate dose if prescribed a direct oral anticoagulant (DOAC). The objectives of this study were to determine the proportion of frail ambulatory older adults with AF who are prescribed OAC, compare the rates of OAC use across the frailty spectrum, assess the appropriateness of DOAC dosing, and identify if frailty and geriatric syndromes impact OAC prescribing patterns. Methods Retrospective cross-sectional review of individuals with AF referred to an ambulatory clinic for older adults living with frailty and/or geriatric syndromes. Rockwood clinical frailty score of ≥4 was used to define frailty and DOAC appropriateness was assessed based on the Canadian Cardiovascular Society AF guidelines. Results Two hundred and ten participants were included. The mean age was 84 years, 49% were female and the median frailty score was 5. Of the 185 participants who were frail, 82% were prescribed an OAC (83% with frailty score of 4, 85% with a frailty score of 5, and 78% with a frailty score of 6). Of those prescribed a DOAC, 70% received a guideline-approved dose. Conclusions Over 80% of ambulatory older adults with frailty and AF were prescribed an OAC. However, of those prescribed a DOAC, 30% received an unapproved dose, suggesting more emphasis should be placed on initial and ongoing dosage selection.

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Direct Oral Anticoagulants and Non-valvular Atrial Fibrillation: Compliance with Dose Level Guidelines in Patients Aged 80 Years and Over

Cited by 3 publications

References 33 publications

Off-Label Reduced Dose Apixaban in Older Adults With Atrial Fibrillation and Associated Outcomes

Off-Label Reduced Dose Apixaban in Older Adults With Atrial Fibrillation and Associated Outcomes

Sex and gender differences in the use of oral anticoagulants for non-valvular atrial fibrillation: A population-based cohort study in primary health care in catalonia

Retrospective Cross-sectional Analysis of Older Adults Living with Frailty and Anticoagulant Use for Atrial Fibrillation

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