Evaluation of the Clinical Outcomes of Apixaban Use in Patients with Atrial Fibrillation and Uncontrolled Hypothyroidism: A Real-world Evidence

Introduction Atrial fibrillation (AF) poses a substantial worldwide health concern, significantly increasing the risk of stroke and morbidity. Direct oral anticoagulants (DOACs) such as apixaban are recommended over vitamin K antagonists for the management of AF. However, the impact of thyroid abnor...

وصف كامل

التفاصيل البيبلوغرافية
الحاوية / القاعدة:Clinical and Applied Thrombosis/Hemostasis
المؤلفون الرئيسيون: Khalid Al Sulaiman BCCCP, BCNSP, MBA, FCCM, Manal A Aljohani PharmD, Abdullah F Alharthi PharmD, Hisham A Badreldin PharmD, Mohammed Y Alzahrani PharmD, Rahaf A Alqahtani PharmD, Walaa A Alshahrani PharmD, Fatimah M Abudayah PhD, Mohammad S Shawaqfeh PharmD, PhD, Ahmed A Alrashed PharmD, Alaa M Alenazi PharmD, Nouf S Alsagri PharmD, Mohammed Yahya Asiri PharmD, Zayed Asiri PharmD, Sulaiman Aljarallah PharmD, Yusuf M. Garwan PharmD, Lama S. Alfehaid PharmD, Abeer A. Alenazi PharmD, Tariq Aldebasi MD, Shmeylan Alharbi PharmD, Ahmed Aldemerdash PharmD, Amer Alzahrani MD, Ohoud Aljuhani PharmD
التنسيق: مقال
اللغة:الإنجليزية
منشور في: SAGE Publishing 2025-09-01
الوصول للمادة أونلاين:https://doi.org/10.1177/10760296251371043
_version_ 1849323537914920960
author Khalid Al Sulaiman BCCCP, BCNSP, MBA, FCCM
Manal A Aljohani PharmD
Abdullah F Alharthi PharmD
Hisham A Badreldin PharmD
Mohammed Y Alzahrani PharmD
Rahaf A Alqahtani PharmD
Walaa A Alshahrani PharmD
Fatimah M Abudayah PhD
Mohammad S Shawaqfeh PharmD, PhD
Ahmed A Alrashed PharmD
Alaa M Alenazi PharmD
Nouf S Alsagri PharmD
Mohammed Yahya Asiri PharmD
Zayed Asiri PharmD
Sulaiman Aljarallah PharmD
Yusuf M. Garwan PharmD
Lama S. Alfehaid PharmD
Abeer A. Alenazi PharmD
Tariq Aldebasi MD
Shmeylan Alharbi PharmD
Ahmed Aldemerdash PharmD
Amer Alzahrani MD
Ohoud Aljuhani PharmD
author_facet Khalid Al Sulaiman BCCCP, BCNSP, MBA, FCCM
Manal A Aljohani PharmD
Abdullah F Alharthi PharmD
Hisham A Badreldin PharmD
Mohammed Y Alzahrani PharmD
Rahaf A Alqahtani PharmD
Walaa A Alshahrani PharmD
Fatimah M Abudayah PhD
Mohammad S Shawaqfeh PharmD, PhD
Ahmed A Alrashed PharmD
Alaa M Alenazi PharmD
Nouf S Alsagri PharmD
Mohammed Yahya Asiri PharmD
Zayed Asiri PharmD
Sulaiman Aljarallah PharmD
Yusuf M. Garwan PharmD
Lama S. Alfehaid PharmD
Abeer A. Alenazi PharmD
Tariq Aldebasi MD
Shmeylan Alharbi PharmD
Ahmed Aldemerdash PharmD
Amer Alzahrani MD
Ohoud Aljuhani PharmD
author_sort Khalid Al Sulaiman BCCCP, BCNSP, MBA, FCCM
collection DOAJ
container_title Clinical and Applied Thrombosis/Hemostasis
description Introduction Atrial fibrillation (AF) poses a substantial worldwide health concern, significantly increasing the risk of stroke and morbidity. Direct oral anticoagulants (DOACs) such as apixaban are recommended over vitamin K antagonists for the management of AF. However, the impact of thyroid abnormalities on DOACs, specifically apixaban in AF patients remains underexplored. Given the limited data, this study aims to evaluate the effectiveness and safety of apixaban in AF patients with uncontrolled hypothyroidism. Methods This study was a retrospective cohort analysis that categorized patients into two sub-cohorts according to their hypothyroidism status at the time they began apixaban treatment: a control group (without hypothyroidism) and an active group (with uncontrolled hypothyroidism). The primary outcome assessed was the rate of thrombosis events following the initiation of apixaban, while bleeding, stroke, and venous thromboembolism (VTE) events were considered as secondary outcomes. Logistic regression analysis was performed, with a p-value of less than .05 deemed statistically significant. Results Among 292 patients included, 51 had uncontrolled hypothyroidism, and 241 were in the control group. Both groups had a median age of 70 years, with predominantly female patients. Any thrombosis events were higher in the uncontrolled hypothyroidism at crude analysis (17.6% vs 8.4%; p-value = .04); as well as higher odds at regression analysis [aOR: 2.40, 95%CI 0.99-5.83; p-value = .05]. In addition, stroke and major bleeding events were significantly higher in the uncontrolled hypothyroidism group (aOR: 4.26, 95%CI 1.51-12.00; p-value = .006 and aOR: 6.21, 95%CI 1.73-22.19; p-value = .005, respectively). The rate of VTE events and minor bleeding did not differ significantly between the two groups. Conclusions The use of apixaban in patients with AF and uncontrolled hypothyroidism was linked to higher rates of thrombosis and major bleeding compared to those without known hypothyroidism. These findings highlight the need for further research through larger prospective studies in this often-overlooked population.
format Article
id doaj-art-ede6ca773bbf41dc9fb4a22e511a6efa
institution Directory of Open Access Journals
issn 1938-2723
language English
publishDate 2025-09-01
publisher SAGE Publishing
record_format Article
spelling doaj-art-ede6ca773bbf41dc9fb4a22e511a6efa2025-09-02T06:10:08ZengSAGE PublishingClinical and Applied Thrombosis/Hemostasis1938-27232025-09-013110.1177/10760296251371043Evaluation of the Clinical Outcomes of Apixaban Use in Patients with Atrial Fibrillation and Uncontrolled Hypothyroidism: A Real-world EvidenceKhalid Al Sulaiman BCCCP, BCNSP, MBA, FCCM0Manal A Aljohani PharmD1Abdullah F Alharthi PharmD2Hisham A Badreldin PharmD3Mohammed Y Alzahrani PharmD4Rahaf A Alqahtani PharmD5Walaa A Alshahrani PharmD6Fatimah M Abudayah PhD7Mohammad S Shawaqfeh PharmD, PhD8Ahmed A Alrashed PharmD9Alaa M Alenazi PharmD10Nouf S Alsagri PharmD11Mohammed Yahya Asiri PharmD12Zayed Asiri PharmD13Sulaiman Aljarallah PharmD14Yusuf M. Garwan PharmD15Lama S. Alfehaid PharmD16Abeer A. Alenazi PharmD17Tariq Aldebasi MD18Shmeylan Alharbi PharmD19Ahmed Aldemerdash PharmD20Amer Alzahrani MD21Ohoud Aljuhani PharmD22 Saudi Society for Multidisciplinary Research Development and Education (SCAPE Society), Riyadh, Saudi Arabia Clinical Trial Management, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia Department of Clinical Pharmacy, College of Pharmacy, , Al-Dawadmi, Saudi Arabia Clinical Trial Management, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia Clinical Trial Management, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia Clinical Trial Management, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia Saudi Critical Care Pharmacy Research (SCAPE) Platform, Riyadh, Saudi Arabia Faculty of Nursing, , Jeddah, Saudi Arabia Clinical Trial Management, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia Administration of Pharmaceutical Services, , Riyadh, Saudi Arabia Pharmaceutical Care Department, , Riyadh, Saudi Arabia Pharmaceutical Care Department, , Riyadh, Saudi Arabia Pharmaceutical Care Department, , Riyadh, Saudi Arabia Pharmaceutical Care Department, , Riyadh, Saudi Arabia Pharmaceutical Care Department, , Riyadh, Saudi Arabia Department of Pharmacy Practice, College of Clinical Pharmacy, , Dammam, Saudi Arabia Clinical Trial Management, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia Pharmaceutical Care Department, , Riyadh, Saudi Arabia Opthalmology department, , Riyadh, Saudi Arabia Clinical Trial Management, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia Department of Clinical Pharmacy, College of Pharmacy, , Riyadh, Saudi Arabia Lung Health Center Department, Organ Transplant Center of Excellence, King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia Pharmacy Practice Department, Faculty of Pharmacy, , Jeddah, Saudi ArabiaIntroduction Atrial fibrillation (AF) poses a substantial worldwide health concern, significantly increasing the risk of stroke and morbidity. Direct oral anticoagulants (DOACs) such as apixaban are recommended over vitamin K antagonists for the management of AF. However, the impact of thyroid abnormalities on DOACs, specifically apixaban in AF patients remains underexplored. Given the limited data, this study aims to evaluate the effectiveness and safety of apixaban in AF patients with uncontrolled hypothyroidism. Methods This study was a retrospective cohort analysis that categorized patients into two sub-cohorts according to their hypothyroidism status at the time they began apixaban treatment: a control group (without hypothyroidism) and an active group (with uncontrolled hypothyroidism). The primary outcome assessed was the rate of thrombosis events following the initiation of apixaban, while bleeding, stroke, and venous thromboembolism (VTE) events were considered as secondary outcomes. Logistic regression analysis was performed, with a p-value of less than .05 deemed statistically significant. Results Among 292 patients included, 51 had uncontrolled hypothyroidism, and 241 were in the control group. Both groups had a median age of 70 years, with predominantly female patients. Any thrombosis events were higher in the uncontrolled hypothyroidism at crude analysis (17.6% vs 8.4%; p-value = .04); as well as higher odds at regression analysis [aOR: 2.40, 95%CI 0.99-5.83; p-value = .05]. In addition, stroke and major bleeding events were significantly higher in the uncontrolled hypothyroidism group (aOR: 4.26, 95%CI 1.51-12.00; p-value = .006 and aOR: 6.21, 95%CI 1.73-22.19; p-value = .005, respectively). The rate of VTE events and minor bleeding did not differ significantly between the two groups. Conclusions The use of apixaban in patients with AF and uncontrolled hypothyroidism was linked to higher rates of thrombosis and major bleeding compared to those without known hypothyroidism. These findings highlight the need for further research through larger prospective studies in this often-overlooked population.https://doi.org/10.1177/10760296251371043
spellingShingle Khalid Al Sulaiman BCCCP, BCNSP, MBA, FCCM
Manal A Aljohani PharmD
Abdullah F Alharthi PharmD
Hisham A Badreldin PharmD
Mohammed Y Alzahrani PharmD
Rahaf A Alqahtani PharmD
Walaa A Alshahrani PharmD
Fatimah M Abudayah PhD
Mohammad S Shawaqfeh PharmD, PhD
Ahmed A Alrashed PharmD
Alaa M Alenazi PharmD
Nouf S Alsagri PharmD
Mohammed Yahya Asiri PharmD
Zayed Asiri PharmD
Sulaiman Aljarallah PharmD
Yusuf M. Garwan PharmD
Lama S. Alfehaid PharmD
Abeer A. Alenazi PharmD
Tariq Aldebasi MD
Shmeylan Alharbi PharmD
Ahmed Aldemerdash PharmD
Amer Alzahrani MD
Ohoud Aljuhani PharmD
Evaluation of the Clinical Outcomes of Apixaban Use in Patients with Atrial Fibrillation and Uncontrolled Hypothyroidism: A Real-world Evidence
title Evaluation of the Clinical Outcomes of Apixaban Use in Patients with Atrial Fibrillation and Uncontrolled Hypothyroidism: A Real-world Evidence
title_full Evaluation of the Clinical Outcomes of Apixaban Use in Patients with Atrial Fibrillation and Uncontrolled Hypothyroidism: A Real-world Evidence
title_fullStr Evaluation of the Clinical Outcomes of Apixaban Use in Patients with Atrial Fibrillation and Uncontrolled Hypothyroidism: A Real-world Evidence
title_full_unstemmed Evaluation of the Clinical Outcomes of Apixaban Use in Patients with Atrial Fibrillation and Uncontrolled Hypothyroidism: A Real-world Evidence
title_short Evaluation of the Clinical Outcomes of Apixaban Use in Patients with Atrial Fibrillation and Uncontrolled Hypothyroidism: A Real-world Evidence
title_sort evaluation of the clinical outcomes of apixaban use in patients with atrial fibrillation and uncontrolled hypothyroidism a real world evidence
url https://doi.org/10.1177/10760296251371043
work_keys_str_mv AT khalidalsulaimanbcccpbcnspmbafccm evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT manalaaljohanipharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT abdullahfalharthipharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT hishamabadreldinpharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT mohammedyalzahranipharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT rahafaalqahtanipharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT walaaaalshahranipharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT fatimahmabudayahphd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT mohammadsshawaqfehpharmdphd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT ahmedaalrashedpharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT alaamalenazipharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT noufsalsagripharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT mohammedyahyaasiripharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT zayedasiripharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT sulaimanaljarallahpharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT yusufmgarwanpharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT lamasalfehaidpharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT abeeraalenazipharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT tariqaldebasimd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT shmeylanalharbipharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT ahmedaldemerdashpharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT ameralzahranimd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence
AT ohoudaljuhanipharmd evaluationoftheclinicaloutcomesofapixabanuseinpatientswithatrialfibrillationanduncontrolledhypothyroidismarealworldevidence