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. 2019 Sep 20;9(9):e031341.
doi: 10.1136/bmjopen-2019-031341.

Appropriateness of initial dose of non-vitamin K antagonist oral anticoagulants in patients with non-valvular atrial fibrillation in the UK

Luis Alberto García Rodríguez  1 , Mar Martín-Pérez  2 , Pareen Vora  3 , Luke Roberts  4 , Yanina Balabanova  3 , Gunnar Brobert  5 , Samuel Fatoba  6 , Kiliana Suzart-Woischnik  3 , Bernhard Schaefer  3 , Ana Ruigomez  2
Affiliations

Appropriateness of initial dose of non-vitamin K antagonist oral anticoagulants in patients with non-valvular atrial fibrillation in the UK

Luis Alberto García Rodríguez et al. BMJ Open. .

Erratum in

Abstract

Objective: To evaluate the appropriateness of the initial prescribed daily dose of non-vitamin K antagonist oral anticoagulants (NOACs) according to label in patients with non-valvular atrial fibrillation (NVAF) in the UK.

Design: Population-based cross-sectional study.

Setting: UK primary care.

Population: 30 467 patients with NVAF and a first prescription for apixaban, dabigatran or rivaroxaban between January 2011 and December 2016.

Main outcome measures: Percentage of patients prescribed a NOAC dose according to the European Union (EU) labels (appropriately dosed), and not according to the EU labels (inappropriately dosed-including both underdosed and overdosed patients); percentage of patients prescribed an initial NOAC dose according to renal function status.

Results: A total of 15 252 (50.1%) patients started NOAC therapy on rivaroxaban, 10 834 (35.6%) on apixaban and 4381 (14.4%) on dabigatran. Among patients starting NOAC therapy on rivaroxaban, 17.3% were eligible to receive a reduced dose compared with 12.8% of patients starting on apixaban and 53.8% of patients starting on dabigatran. The majority of patients were prescribed an appropriate dose according to the EU labels: apixaban 74.9 %, dabigatran, 74.4%; rivaroxaban, 84.2%. Underdosing occurred in 21.6% (apixaban), 8.7% (dabigatran), 9.1% (rivaroxaban). Overdosing was more frequent for dabigatran (16.9%) than for rivaroxaban (6.6%) or apixaban (3.5%). There was a trend towards dose reduction with increasing renal impairment. Among patients with severe renal impairment, the majority received a reduced dose NOAC: apixaban, 91.1%, dabigatran, 80.0%, rivaroxaban, 83.0%.

Conclusion: Between 2011 and 2016, the majority of patients starting NOAC therapy in UK primary care were prescribed a daily dose in line with the approved EU drug label. Underdosing was more than twice as common among patients starting on apixaban than those starting on dabigatran or rivaroxaban. Research into the patient characteristics that may influence inappropriate underdosing of NOACs in UK primary care is warranted.

Keywords: Cardiac Epidemiology; EPIDEMIOLOGY; Thromboembolism.

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Conflict of interest statement

Competing interests: PV, YB, KS-W and BS are employees of Bayer AG (Germany), the funder of the study. GB is an employee of Bayer AB (Stockholm, Sweden). LR and SF are employees of Bayer PLC (Reading, UK). KS-W declares Bayer stocks. LR and SF declare shares in Bayer. LAGR, MM-P and AR work for the Spanish Centre for Pharmacoepidemiologic Research (Madrid, Spain), which has received research funding from Bayer AG. LAGR also declares honoraria for serving on advisory boards for Bayer AG.

Figures

Figure 1
Figure 1
Overall appropriateness of index NOAC daily dose (first prescribed NOAC). Overdosed includes patients who received a higher dose than recommended plus patients who were contraindicated. NOAC, non-vitamin K antagonist oral anticoagulant.
Figure 2
Figure 2
Daily dose of the index NOAC prescription by degree of renal impairment* for (A) new users of apixaban, (B) new users of dabigatran and (C) new users of rivaroxaban, in patients with NVAF and no other recent indication. Renal function was unknown in 13.6% of the apixaban cohort, 12.3% of the dabigatran cohort and 13.0% of the rivaroxaban cohort. *Estimated using the chronic kidney disease epidemiology collaboration equation. eGFR, estimated glomerular filtration rate; NOAC, non-vitamin K antagonist oral anticoagulant; NVAF, non-valvular atrial fibrillation.
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