New oral anticoagulants: appropriateness of prescribing in real‐world setting

Pattullo, Champika; Barras, Michael; Tai, Bonnie; McKean, Mitchell; Donovan, Peter

doi:10.1111/imj.13118

Cited by 54 publications

(65 citation statements)

References 21 publications

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“…With a median age of 85 years, the OAC patients in our study were substantially older than those participating in the respective phase III trials where dabigatran, rivaroxaban, or apixaban were compared with warfarin . Further, a high proportion of patients had renal disease and other comorbid conditions and frequently received other medication indicating that in this real world situation, patient characteristics do not match the trial settings .…”

Section: Discussionmentioning

confidence: 90%

Use of oral anticoagulants in German nursing home residents: drug use patterns and predictors for treatment choice

Jobski

Hoffmann

Herget–Rosenthal

et al. 2018

Brit J Clinical Pharma

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Section: Discussionmentioning

confidence: 90%

Use of oral anticoagulants in German nursing home residents: drug use patterns and predictors for treatment choice

Jobski

Hoffmann

Herget–Rosenthal

et al. 2018

Brit J Clinical Pharma

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“…(C) Real‐world studies results concerning dose adjustments of apixaban. (D) Results from direct oral anticoagulants overall adjustments regarding dose appropriateness…”

Section: Resultsmentioning

confidence: 99%

Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

Santos

António

Rocha³

et al. 2020

Brit J Clinical Pharma

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Aims Worldwide observational studies are evidencing discordance between guidelines and real‐world practice regarding direct oral anticoagulant drug (DOAC) doses. This systematic review summarizes and evaluate DOACs use in real‐world practice. Methods This review was performed following the preferred reporting items for systematic reviews and meta‐analyses (PRISMA) guidelines searching PubMed (MEDLINE) and Medscape databases. Results Data from 75 studies showed that most of the patients treated with DOACs for stroke prevention in atrial fibrillation received doses in accordance to the guidelines. However, a significant number of patients received off‐label doses (25–50% in most of the studies evaluated). DOAC overdosing was associated with increased all‐cause mortality and worse bleeding events while underdosing was associated with increased cardiovascular hospitalization and, particularly for apixaban, with a nearly 5‐fold increased risk of stroke. Conclusion Patients prescribed with off‐label DOAC doses did not receive the full benefit of anticoagulation and presented an increased risk of stroke, bleeding and/or adverse effects.

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“…Those data also suggested an overall high rate of prescriptions for the lower doses of these medications, and the present analysis explores that phenomenon in depth. The only previous studies of reduced NOAC dosing have been described across 3 centers in Australia and in a single‐center report from the United States 15, 16. Both studies suggested a high rate of inappropriate dosing for patients with AF receiving NOACs but were limited to fewer than 300 patients and not specifically designed to address inappropriate dose reductions.…”

Section: Discussionmentioning

confidence: 99%

Frequency and Outcomes of Reduced Dose Non–Vitamin K Antagonist Anticoagulants: Results From ORBIT‐AF II (The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II)

Steinberg

Shrader

Pieper

et al. 2018

JAHA

174

160

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BackgroundNon–vitamin K antagonist oral anticoagulants (NOACs) are indicated for stroke prevention in atrial fibrillation (AF) but require lower doses in certain patients. We sought to describe the frequency, appropriateness (according to Food and Drug Administration labeling), and outcomes of patients prescribed reduced doses of NOACs in community practice.Methods and ResultsWe analyzed data from the ORBIT‐AF II (The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II) registry, a prospective, national, observational registry of AF patients. Among 7925 AF patients receiving NOACs, we assessed patterns of use of reduced NOAC doses and associated cardiovascular and bleeding outcomes at median follow‐up of 1 year. Overall, 6636 patients (84%) received a NOAC at standard dose, which was consistent with US Food and Drug Administration labeling in 6376 (96%). Reduced NOAC dose was prescribed to 1289 (16% overall), which was consistent with Food and Drug Administration labeling in only 555 patients (43%). Compared with those whose NOAC dose was appropriately reduced, patients receiving inappropriate dose reductions were younger (median age 79 versus 84, P<0.0001) and had lower ORBIT bleeding risk scores (26% ≥4 versus 45%, P<0.0001). Compared with those appropriately receiving standard dosing, patients receiving inappropriately reduced‐dose NOACs had higher unadjusted rates of thromboembolic events (2.11 versus 1.35 events per 100 patient years, hazard ratio 1.56, 95% confidence interval 0.92‐2.67) and death (6.77 versus 2.60, hazard ratio 2.61, 95% confidence interval 1.86‐3.67). After adjustment, outcomes were not significantly different but tended to favor patients dosed appropriately.ConclusionsThe majority of dose reductions of NOACs in AF are inconsistent with US Food and Drug Administration recommendations. There appear to be opportunities to improve current NOAC dosing in community practice.Clinical Trial RegistrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT01701817.

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New oral anticoagulants: appropriateness of prescribing in real‐world setting

Cited by 54 publications

References 21 publications

Use of oral anticoagulants in German nursing home residents: drug use patterns and predictors for treatment choice

Use of oral anticoagulants in German nursing home residents: drug use patterns and predictors for treatment choice

Impact of direct oral anticoagulant off‐label doses on clinical outcomes of atrial fibrillation patients: A systematic review

Frequency and Outcomes of Reduced Dose Non–Vitamin K Antagonist Anticoagulants: Results From ORBIT‐AF II (The Outcomes Registry for Better Informed Treatment of Atrial Fibrillation II)

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