Impact of anticoagulant exposure misclassification on the bleeding risk of direct oral anticoagulants

AIMS: Drug exposure status based on routinely collected data might be misclassified when the database contains only prescriptions from 1 type of prescriber (e.g. general practitioner and not specialist). This study aims to quantify the impact of such exposure misclassification on the risk of major b...

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Autores principales: Hempenius, Mirjam, Groenwold, Rolf H. H., Souverein, Patrick C., de Boer, Anthonius, Klungel, Olaf H., Gardarsdottir, Helga
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8451929/
https://www.ncbi.nlm.nih.gov/pubmed/33543516
http://dx.doi.org/10.1111/bcp.14764
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author Hempenius, Mirjam
Groenwold, Rolf H. H.
Souverein, Patrick C.
de Boer, Anthonius
Klungel, Olaf H.
Gardarsdottir, Helga
author_facet Hempenius, Mirjam
Groenwold, Rolf H. H.
Souverein, Patrick C.
de Boer, Anthonius
Klungel, Olaf H.
Gardarsdottir, Helga
author_sort Hempenius, Mirjam
collection PubMed
description AIMS: Drug exposure status based on routinely collected data might be misclassified when the database contains only prescriptions from 1 type of prescriber (e.g. general practitioner and not specialist). This study aims to quantify the impact of such exposure misclassification on the risk of major bleeding and stroke/transient ischaemic attack (TIA)associated with direct oral anticoagulants (DOACs) vs. vitamin K antagonists (VKAs). METHODS: Incident anticoagulant users (>12 mo free of anticoagulation use) in the Dutch PHARMO Database Network between 2008 and 2017 were included. Drug exposure was assessed using pharmacy dispensing information. The risks of hospital admission of major bleeding for DOAC vs. VKA users was assessed with Cox regression analysis, where exposure was based on all dispensings, on general practitioner (GP)‐prescribed dispensings only or on specialist‐prescribed dispensings only. Hazard ratios (HRs) were estimated also for hospitalization for gastrointestinal bleeding, intracranial bleeding and stroke/TIA. RESULTS: We included 99 182 VKA‐initiators and 21 795 DOAC‐initiators. Use of DOAC was associated with a lower risk of major bleeding compared to VKA use; HR 0.79 (95% confidence interval 0.70–0.90), 0.78 (0.68–0.91) and 0.62 (0.50–0.76), for exposure based on complete dispensing information, only GP‐ and only specialist‐prescribed dispensings, respectively. Similar results were found for the other bleeding outcomes. For stroke/TIA the HRs were 0.96 (0.84–1.09), 1.00 (0.84–1.18) and 0.72 (0.58–0.90), respectively. CONCLUSION: Including only GP‐prescribed anticoagulant dispensings in this case did not materially impact the effect estimates compared to including all anticoagulant dispensings. Including only specialist‐prescribed dispensings, however, strengthened the effect estimates.
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spelling pubmed-84519292021-09-27 Impact of anticoagulant exposure misclassification on the bleeding risk of direct oral anticoagulants Hempenius, Mirjam Groenwold, Rolf H. H. Souverein, Patrick C. de Boer, Anthonius Klungel, Olaf H. Gardarsdottir, Helga Br J Clin Pharmacol Original Articles AIMS: Drug exposure status based on routinely collected data might be misclassified when the database contains only prescriptions from 1 type of prescriber (e.g. general practitioner and not specialist). This study aims to quantify the impact of such exposure misclassification on the risk of major bleeding and stroke/transient ischaemic attack (TIA)associated with direct oral anticoagulants (DOACs) vs. vitamin K antagonists (VKAs). METHODS: Incident anticoagulant users (>12 mo free of anticoagulation use) in the Dutch PHARMO Database Network between 2008 and 2017 were included. Drug exposure was assessed using pharmacy dispensing information. The risks of hospital admission of major bleeding for DOAC vs. VKA users was assessed with Cox regression analysis, where exposure was based on all dispensings, on general practitioner (GP)‐prescribed dispensings only or on specialist‐prescribed dispensings only. Hazard ratios (HRs) were estimated also for hospitalization for gastrointestinal bleeding, intracranial bleeding and stroke/TIA. RESULTS: We included 99 182 VKA‐initiators and 21 795 DOAC‐initiators. Use of DOAC was associated with a lower risk of major bleeding compared to VKA use; HR 0.79 (95% confidence interval 0.70–0.90), 0.78 (0.68–0.91) and 0.62 (0.50–0.76), for exposure based on complete dispensing information, only GP‐ and only specialist‐prescribed dispensings, respectively. Similar results were found for the other bleeding outcomes. For stroke/TIA the HRs were 0.96 (0.84–1.09), 1.00 (0.84–1.18) and 0.72 (0.58–0.90), respectively. CONCLUSION: Including only GP‐prescribed anticoagulant dispensings in this case did not materially impact the effect estimates compared to including all anticoagulant dispensings. Including only specialist‐prescribed dispensings, however, strengthened the effect estimates. John Wiley and Sons Inc. 2021-03-04 2021-09 /pmc/articles/PMC8451929/ /pubmed/33543516 http://dx.doi.org/10.1111/bcp.14764 Text en © 2021 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of British Pharmacological Society. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.
spellingShingle Original Articles
Hempenius, Mirjam
Groenwold, Rolf H. H.
Souverein, Patrick C.
de Boer, Anthonius
Klungel, Olaf H.
Gardarsdottir, Helga
Impact of anticoagulant exposure misclassification on the bleeding risk of direct oral anticoagulants
title Impact of anticoagulant exposure misclassification on the bleeding risk of direct oral anticoagulants
title_full Impact of anticoagulant exposure misclassification on the bleeding risk of direct oral anticoagulants
title_fullStr Impact of anticoagulant exposure misclassification on the bleeding risk of direct oral anticoagulants
title_full_unstemmed Impact of anticoagulant exposure misclassification on the bleeding risk of direct oral anticoagulants
title_short Impact of anticoagulant exposure misclassification on the bleeding risk of direct oral anticoagulants
title_sort impact of anticoagulant exposure misclassification on the bleeding risk of direct oral anticoagulants
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8451929/
https://www.ncbi.nlm.nih.gov/pubmed/33543516
http://dx.doi.org/10.1111/bcp.14764
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