Evaluation of Apixaban safety and effectiveness in morbidly obese patients with atrial fibrillation: a retrospective cohort study

Abstract Background The benefit of apixaban to reduce stroke risk in morbidly obese patients with nonvalvular atrial fibrillation (AF) is still undetermined. The International Society of Thrombosis and Hemostasis recommends avoiding the use of direct oral anticoagulants (DOAC)s in morbidly obese pat...

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Main Authors: Khalid Al Sulaiman, Hisham A. Badreldin, Ghazwa B. Korayem, Abeer A. Alenazi, Faisal Alsuwayyid, Abdulrahman Alrashidi, Mohammed Alhijris, Faisal Almutairi, Fahad Alharthi, Ramesh Vishwakarma, Omar Al Shaya, Abdulrahman Al Amri, Saqiba Tayyab, Abdulkareem M. Al Bekairy, Ohoud Aljuhani
Format: Article
Language:English
Published: BMC 2022-05-01
Series:Thrombosis Journal
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Online Access:https://doi.org/10.1186/s12959-022-00379-x
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author Khalid Al Sulaiman
Hisham A. Badreldin
Ghazwa B. Korayem
Abeer A. Alenazi
Faisal Alsuwayyid
Abdulrahman Alrashidi
Mohammed Alhijris
Faisal Almutairi
Fahad Alharthi
Ramesh Vishwakarma
Omar Al Shaya
Abdulrahman Al Amri
Saqiba Tayyab
Abdulkareem M. Al Bekairy
Ohoud Aljuhani
author_facet Khalid Al Sulaiman
Hisham A. Badreldin
Ghazwa B. Korayem
Abeer A. Alenazi
Faisal Alsuwayyid
Abdulrahman Alrashidi
Mohammed Alhijris
Faisal Almutairi
Fahad Alharthi
Ramesh Vishwakarma
Omar Al Shaya
Abdulrahman Al Amri
Saqiba Tayyab
Abdulkareem M. Al Bekairy
Ohoud Aljuhani
author_sort Khalid Al Sulaiman
collection DOAJ
description Abstract Background The benefit of apixaban to reduce stroke risk in morbidly obese patients with nonvalvular atrial fibrillation (AF) is still undetermined. The International Society of Thrombosis and Hemostasis recommends avoiding the use of direct oral anticoagulants (DOAC)s in morbidly obese patients (body mass index > 40 or weight > 120 kg) because of limited clinical data. This exploratory study aims to evaluate the effectiveness and safety of using apixaban in morbidly obese (body mass index (BMI) ≥ 40) patients with AF. Methods An exploratory retrospective cohort study was conducted at a single-center, including adult patients with non-valvular AF using apixaban between 01/01/2016 and 31/12/2019. Patients were excluded if they were known to have liver cirrhosis Child-Pugh C, mechanical valve, serum creatinine > 1.5 mg/dL, follow up < 3 months, or using apixaban with a dose of ≤5 or > 10 mg/day. Included patients were categorized into two groups based on their BMI (BMI<40 Vs. BMI ≥ 40). The primary outcome was all thrombotic events, while the secondary outcomes were major and minor bleeding after apixaban initiation. Propensity score (PS) matching was used (1:1 ratio) based on the patient’s age, gender, and HAS-BLED score. Results A total of 722 patients were eligible; 254 patients were included after propensity score matching based on the selected criteria. The prevalence of all thrombotic events was similar between the two groups in the first year of apixaban initiation (OR (95%CI): 0.58 (0.13, 2.5), p-value = 0.46). In addition, the odds of developing major and minor bleeding were not statistically significant between the two groups (OR (95%CI): 0.39 (0.07, 2.03), p-value = 0.26 and OR (95%CI): 1.27 (0.56, 2.84), p-value = 0.40), respectively). Conclusion This exploratory study showed similar effectiveness and safety of apixaban use in both morbid and non-morbid obese patients with non-valvular AF. However, a larger randomized controlled trial with a longer follow-up period needs to confirm our findings.
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spelling doaj.art-17b0f96e88de4b38bb8b14763be870322022-12-22T02:35:42ZengBMCThrombosis Journal1477-95602022-05-012011910.1186/s12959-022-00379-xEvaluation of Apixaban safety and effectiveness in morbidly obese patients with atrial fibrillation: a retrospective cohort studyKhalid Al Sulaiman0Hisham A. Badreldin1Ghazwa B. Korayem2Abeer A. Alenazi3Faisal Alsuwayyid4Abdulrahman Alrashidi5Mohammed Alhijris6Faisal Almutairi7Fahad Alharthi8Ramesh Vishwakarma9Omar Al Shaya10Abdulrahman Al Amri11Saqiba Tayyab12Abdulkareem M. Al Bekairy13Ohoud Aljuhani14Pharmaceutical Care Department, King Abdulaziz Medical CityPharmaceutical Care Department, King Abdulaziz Medical CityDepartment of Pharmacy Practice, College of Pharmacy, Princess Nourah bint Abdulrahman UniversityPharmaceutical Care Department, Prince Sultan Military Medical CityCollege of Pharmacy, King Saud bin Abdulaziz University for Health SciencesCollege of Pharmacy, King Saud bin Abdulaziz University for Health SciencesCollege of Pharmacy, King Saud bin Abdulaziz University for Health SciencesCollege of Pharmacy, King Saud bin Abdulaziz University for Health SciencesCollege of Pharmacy, King Saud bin Abdulaziz University for Health SciencesStatistics Department, European Organization for Research and Treatment of Cancer (EORTC) HeadquartersPharmaceutical Care Department, King Abdulaziz Medical CityPharmaceutical Care Department, King Abdulaziz Medical CityPharmaceutical Care Department, Care national hospitalPharmaceutical Care Department, King Abdulaziz Medical CityDepartment of Pharmacy Practice, Faculty of Pharmacy, King Abdulaziz UniversityAbstract Background The benefit of apixaban to reduce stroke risk in morbidly obese patients with nonvalvular atrial fibrillation (AF) is still undetermined. The International Society of Thrombosis and Hemostasis recommends avoiding the use of direct oral anticoagulants (DOAC)s in morbidly obese patients (body mass index > 40 or weight > 120 kg) because of limited clinical data. This exploratory study aims to evaluate the effectiveness and safety of using apixaban in morbidly obese (body mass index (BMI) ≥ 40) patients with AF. Methods An exploratory retrospective cohort study was conducted at a single-center, including adult patients with non-valvular AF using apixaban between 01/01/2016 and 31/12/2019. Patients were excluded if they were known to have liver cirrhosis Child-Pugh C, mechanical valve, serum creatinine > 1.5 mg/dL, follow up < 3 months, or using apixaban with a dose of ≤5 or > 10 mg/day. Included patients were categorized into two groups based on their BMI (BMI<40 Vs. BMI ≥ 40). The primary outcome was all thrombotic events, while the secondary outcomes were major and minor bleeding after apixaban initiation. Propensity score (PS) matching was used (1:1 ratio) based on the patient’s age, gender, and HAS-BLED score. Results A total of 722 patients were eligible; 254 patients were included after propensity score matching based on the selected criteria. The prevalence of all thrombotic events was similar between the two groups in the first year of apixaban initiation (OR (95%CI): 0.58 (0.13, 2.5), p-value = 0.46). In addition, the odds of developing major and minor bleeding were not statistically significant between the two groups (OR (95%CI): 0.39 (0.07, 2.03), p-value = 0.26 and OR (95%CI): 1.27 (0.56, 2.84), p-value = 0.40), respectively). Conclusion This exploratory study showed similar effectiveness and safety of apixaban use in both morbid and non-morbid obese patients with non-valvular AF. However, a larger randomized controlled trial with a longer follow-up period needs to confirm our findings.https://doi.org/10.1186/s12959-022-00379-xApixabanMorbidly obeseBMI ≥ 40Atrial fibrillationThrombosisBleeding
spellingShingle Khalid Al Sulaiman
Hisham A. Badreldin
Ghazwa B. Korayem
Abeer A. Alenazi
Faisal Alsuwayyid
Abdulrahman Alrashidi
Mohammed Alhijris
Faisal Almutairi
Fahad Alharthi
Ramesh Vishwakarma
Omar Al Shaya
Abdulrahman Al Amri
Saqiba Tayyab
Abdulkareem M. Al Bekairy
Ohoud Aljuhani
Evaluation of Apixaban safety and effectiveness in morbidly obese patients with atrial fibrillation: a retrospective cohort study
Thrombosis Journal
Apixaban
Morbidly obese
BMI ≥ 40
Atrial fibrillation
Thrombosis
Bleeding
title Evaluation of Apixaban safety and effectiveness in morbidly obese patients with atrial fibrillation: a retrospective cohort study
title_full Evaluation of Apixaban safety and effectiveness in morbidly obese patients with atrial fibrillation: a retrospective cohort study
title_fullStr Evaluation of Apixaban safety and effectiveness in morbidly obese patients with atrial fibrillation: a retrospective cohort study
title_full_unstemmed Evaluation of Apixaban safety and effectiveness in morbidly obese patients with atrial fibrillation: a retrospective cohort study
title_short Evaluation of Apixaban safety and effectiveness in morbidly obese patients with atrial fibrillation: a retrospective cohort study
title_sort evaluation of apixaban safety and effectiveness in morbidly obese patients with atrial fibrillation a retrospective cohort study
topic Apixaban
Morbidly obese
BMI ≥ 40
Atrial fibrillation
Thrombosis
Bleeding
url https://doi.org/10.1186/s12959-022-00379-x
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