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Safety of idarucizumab in the reversal of dabigatran at six tertiary care Ontario hospitals

BACKGROUND: Idarucizumab, a monoclonal antibody fragment that reverses the anticoagulant effect of dabigatran, was approved for use in Canada in 2016. OBJECTIVE: Our objective was to assess the safety of idarucizumab among patients who received the drug within the first 3 years of its use in Canada....

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Autores principales: Abdulrehman, Jameel, Zarabi, Sahar, Elbaz, Carolyne, de Wit, Kerstin, Lin, Yulia, Sholzberg, Michelle, Selby, Rita
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/PMC8348998/
https://www.ncbi.nlm.nih.gov/pubmed/34401639
http://dx.doi.org/10.1002/rth2.12535
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author Abdulrehman, Jameel
Zarabi, Sahar
Elbaz, Carolyne
de Wit, Kerstin
Lin, Yulia
Sholzberg, Michelle
Selby, Rita
author_facet Abdulrehman, Jameel
Zarabi, Sahar
Elbaz, Carolyne
de Wit, Kerstin
Lin, Yulia
Sholzberg, Michelle
Selby, Rita
author_sort Abdulrehman, Jameel
collection PubMed
description BACKGROUND: Idarucizumab, a monoclonal antibody fragment that reverses the anticoagulant effect of dabigatran, was approved for use in Canada in 2016. OBJECTIVE: Our objective was to assess the safety of idarucizumab among patients who received the drug within the first 3 years of its use in Canada. PATIENTS/METHODS: We performed a retrospective health records review of all idarucizumab use, excluding use in those <18 years of age, between May 16, 2016, and August 1, 2019, at six Ontario tertiary care hospitals. The primary outcome was mortality. The secondary outcomes were in‐hospital arterial thrombotic event (ATE), in‐hospital venous thromboembolism (VTE), length of hospital stay, and length of critical care stay. RESULTS: A total of 85 patients received idarucizumab during the study period for the following indications: 37 (43.5%) for spontaneous bleeding, 28 (32.9%) for traumatic bleeding, 11 (12.9%) for emergency surgeries/procedures, 5 (5.9%) for elective surgeries/procedures, and 4 (4.7%) for other indications. Nineteen patients (22.4%; 95% confidence interval [CI], 14.8%‐32.3%) did not survive their hospitalization. During hospitalization, two patients (2.4%; 95% CI, 0.7%‐8.2%) had ATE, and three patients (3.5%; 95% CI, 1.2%‐9.9%) had VTE. The median length of stay was 8 (interquartile range [IQR], 2.5‐13) days in hospital and 3 (IQR, 2‐5) days in critical care. CONCLUSIONS: Compared with clinical trial data, we found a numerically higher rate of mortality and similar rate of ATE and VTE among patients treated with idarucizumab in the real world.
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spelling pubmed-83489982021-08-15 Safety of idarucizumab in the reversal of dabigatran at six tertiary care Ontario hospitals Abdulrehman, Jameel Zarabi, Sahar Elbaz, Carolyne de Wit, Kerstin Lin, Yulia Sholzberg, Michelle Selby, Rita Res Pract Thromb Haemost Brief Reports BACKGROUND: Idarucizumab, a monoclonal antibody fragment that reverses the anticoagulant effect of dabigatran, was approved for use in Canada in 2016. OBJECTIVE: Our objective was to assess the safety of idarucizumab among patients who received the drug within the first 3 years of its use in Canada. PATIENTS/METHODS: We performed a retrospective health records review of all idarucizumab use, excluding use in those <18 years of age, between May 16, 2016, and August 1, 2019, at six Ontario tertiary care hospitals. The primary outcome was mortality. The secondary outcomes were in‐hospital arterial thrombotic event (ATE), in‐hospital venous thromboembolism (VTE), length of hospital stay, and length of critical care stay. RESULTS: A total of 85 patients received idarucizumab during the study period for the following indications: 37 (43.5%) for spontaneous bleeding, 28 (32.9%) for traumatic bleeding, 11 (12.9%) for emergency surgeries/procedures, 5 (5.9%) for elective surgeries/procedures, and 4 (4.7%) for other indications. Nineteen patients (22.4%; 95% confidence interval [CI], 14.8%‐32.3%) did not survive their hospitalization. During hospitalization, two patients (2.4%; 95% CI, 0.7%‐8.2%) had ATE, and three patients (3.5%; 95% CI, 1.2%‐9.9%) had VTE. The median length of stay was 8 (interquartile range [IQR], 2.5‐13) days in hospital and 3 (IQR, 2‐5) days in critical care. CONCLUSIONS: Compared with clinical trial data, we found a numerically higher rate of mortality and similar rate of ATE and VTE among patients treated with idarucizumab in the real world. John Wiley and Sons Inc. 2021-08-07 /pmc/articles/PMC8348998/ /pubmed/34401639 http://dx.doi.org/10.1002/rth2.12535 Text en © 2021 The Authors. Research and Practice in Thrombosis and Haemostasis published by Wiley Periodicals LLC on behalf of International Society on Thrombosis and Haemostasis (ISTH). https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Brief Reports
Abdulrehman, Jameel
Zarabi, Sahar
Elbaz, Carolyne
de Wit, Kerstin
Lin, Yulia
Sholzberg, Michelle
Selby, Rita
Safety of idarucizumab in the reversal of dabigatran at six tertiary care Ontario hospitals
title Safety of idarucizumab in the reversal of dabigatran at six tertiary care Ontario hospitals
title_full Safety of idarucizumab in the reversal of dabigatran at six tertiary care Ontario hospitals
title_fullStr Safety of idarucizumab in the reversal of dabigatran at six tertiary care Ontario hospitals
title_full_unstemmed Safety of idarucizumab in the reversal of dabigatran at six tertiary care Ontario hospitals
title_short Safety of idarucizumab in the reversal of dabigatran at six tertiary care Ontario hospitals
title_sort safety of idarucizumab in the reversal of dabigatran at six tertiary care ontario hospitals
topic Brief Reports
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8348998/
https://www.ncbi.nlm.nih.gov/pubmed/34401639
http://dx.doi.org/10.1002/rth2.12535
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