PRescriptiOn PattERns of Oral Anticoagulants in Nonvalvular Atrial Fibrillation (PROPER study)

Başaran, Özcan; Başaran, Nesrin Filiz; Çekiç, Edip Güvenç; Altun, İbrahim; Doğan, Volkan; Mert, Gurbet Özge; Mert, Kadir Uğur; Akın, Fatih; Soylu, Mustafa; Sancar, Kadriye Memiç; Biteker, Murat

doi:10.1177/1076029615614395

Cited by 46 publications

(50 citation statements)

References 26 publications

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“…Earlier study evaluating prescription patterns of oral anticoagulants (OAC) found up to 47% of off-label use of NOACs. [8] Similarly, in a study conducted in Danish population, high prevalence of off-label prescription of dabigatran was noticed. [9] The misuse of NOACs indicated by the real-world data could be a possible reason for the adverse events.…”

Section: Introductionmentioning

confidence: 91%

Suboptimal use of non-vitamin K antagonist oral anticoagulants

et al. 2016

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This study aimed to investigate the potential misuse of novel oral anticoagulants (NOACs) and the physicians’ adherence to current European guideline recommendations in real-world using a large dataset from Real-life Multicenter Survey Evaluating Stroke Prevention Strategies in Turkey (RAMSES Study).RAMSES study is a prospective, multicenter, nationwide registry (ClinicalTrials.gov identifier NCT02344901). In this subgroup analysis of RAMSES study, patients who were on NOACs were classified as appropriately treated (AT), undertreated (UT), and overtreated (OT) according to the European Society of Cardiology (ESC) guidelines. The independent predictors of UT and OT were determined by multivariate logistic regression.Of the 2086 eligible patients, 1247 (59.8%) received adequate treatment. However, off-label use was detected in 839 (40.2%) patients; 634 (30.4%) patients received UT and 205 (9.8%) received OT. Independent predictors of UT included >65 years of age, creatinine clearance ≥50 mL/min, urban living, existing dabigatran treatment, and HAS-BLED score of <3, whereas that of OT were creatinine clearance <50 mL/min, ongoing rivaroxaban treatment, and HAS-BLED score of ≥3.The suboptimal use of NOACs is common because of physicians’ poor compliance to the guideline recommendations in patients with nonvalvular atrial fibrillation (NVAF). Older patients who were on dabigatran treatment with good renal functions and low risk of bleeding were at risk of UT, whereas patients who were on rivaroxaban treatment with renal impairment and high risk of bleeding were at risk of OT. Therefore, a greater emphasis should be given to prescribe the recommended dose for the specified patients.

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Section: Introductionmentioning

confidence: 91%

Suboptimal use of non-vitamin K antagonist oral anticoagulants

et al. 2016

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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%

“…Canadian study, 44 where a total of 47 patients were included, among (D) Results from direct oral anticoagulants overall adjustments regarding dose appropriateness 5,9,11,25,27,28,32,34,37,39,40,42,44,[47][48][49][50][51][52][53][54][55][56][57][58][59][60][61][62][63][64] whom 25 (53%) were receiving apixaban inconsistent with the ARIS-TOTLE trial and the product monograph.…”

Section: Study and Also By A Smallmentioning

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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“…In a single-center study of 148 patients, rivaroxaban was found to be dosed inappropriately according to the Medication Appropriateness Index in 23% of patients vs. 42% and 81% of patients on dabigatran and warfarin, respectively 6 . This may suggest that simpler dosing adjustment criteria may lead to less inappropriate dosing with oral anticoagulants.…”

Section: Discussionmentioning

confidence: 99%

Doses of apixaban and rivaroxaban prescribed in real-world United States cardiology practices compared to registration trials

Nguyen

White

Patel

et al. 2016

Current Medical Research and Opinion

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Using an I.M.S. LifeLink dataset (19 September 2014-11 September 2015), we compared U.S. cardiologist prescribing of the reduced dose of apixaban (2.5 mg) or rivaroxaban (15 mg) to utilization in their corresponding nonvalvular atrial fibrillation registration randomized trials. Of all prescriptions written by cardiologists for these agents, 20.8% of apixaban and 21.7% of rivaroxaban prescriptions were for a reduced dose; corresponding to a 4.4-fold (16.1% absolute) increase in the use of reduced dose apixaban and a 3% relative (0.6% absolute) increase in reduced dose rivaroxaban use vs. their respective registration trials. Further research is needed to better understand appropriate dosing of patients with novel anticoagulants.

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PRescriptiOn PattERns of Oral Anticoagulants in Nonvalvular Atrial Fibrillation (PROPER study)

Abstract: Inappropriate drug use is frequent among patients with NVAF not only for warfarin but also for NOACs. Although there is an apparent improvement in thromboprophylaxis of NVAF, much more effort is needed for appropriate use of OACs.

Cited by 46 publications

References 26 publications

Suboptimal use of non-vitamin K antagonist oral anticoagulants

Suboptimal use of non-vitamin K antagonist oral anticoagulants

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

Doses of apixaban and rivaroxaban prescribed in real-world United States cardiology practices compared to registration trials

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