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Stroke and Bleeding Risks in Patients with Atrial Fibrillation Treated with Reduced Apixaban Dose: A Real-Life Study.
Clin Pharmacol Ther. 2020 Jun 19 [Online ahead of print]CP

Abstract

The purpose of this study was to assess the association between reduced apixaban dose and two outcomes: ischemic stroke/systemic embolism (SE) and major bleeding. We performed a retrospective cohort study within the database of the largest healthcare provider in Israel. We identified all patients diagnosed with atrial fibrillation, who started apixaban treatment between 2013 and 2017. Apixaban users were classified into three dosing regimen groups based on their renal function, age, and weight: standard dose (5 mg b.i.d.), adjusted reduced dose (2.5 mg b.i.d.), and underdosing (2.5 mg b.i.d.). Patients were followed through 2018 for the occurrence of stroke/SE and major bleeding. Of the 27,765 included patients, 13,141 (47%) adequately received standard apixaban dose, 4,739 patients (17%) received adjusted reduced dose, and 9,885 patients (36%) were classified as underdosed. The CHA2DS2-VASc score adjusted hazard ratio for ischemic stroke/SE was 1.1 (95% confidence interval (CI), 0.83-1.43) in the adjusted reduced dose group, and 1.04 (95% CI, 0.83-1.35) in the underdosing group, compared with the standard apixaban dose group. The HAS-BLED score adjusted hazard ratio for any major bleeding was 1.66 (95% CI, 1.32-2.09) in the adjusted reduced dose group, and 1.51 (95% CI, 1.24-1.83) in the underdosing group, compared with apixaban in the standard dose group. Results were similar for major gastrointestinal bleeding and intracranial hemorrhage separately. We conclude that underdosing with apixaban is very common, and may not disproportionately elevate the risk of ischemic stroke. However, albeit halving the dose, patients treated with reduced apixaban dose (adjusted or underdosing) seem to be at higher risk for major bleeding.

Authors+Show Affiliations

Pharmaceutical Services, Lady Davis Carmel Medical Center, Haifa, Israel.Department of Community Medicine and Epidemiology, Lady Davis Carmel Medical Center, Haifa, Israel. Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.Department of Community Medicine and Epidemiology, Lady Davis Carmel Medical Center, Haifa, Israel.Institute of Hematology, Lady Davis Carmel Medical Center, Haifa, Israel.Department of Community Medicine and Epidemiology, Lady Davis Carmel Medical Center, Haifa, Israel. Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.The Department of Neurology, Rabin Medical Center, Petach Tikva, Israel. Sackler Faculty of Medicine, Tel Aviv University, Tel-Aviv, Israel.Department of Community Medicine and Epidemiology, Lady Davis Carmel Medical Center, Haifa, Israel. Ruth and Bruce Rappaport Faculty of Medicine, Technion-Israel Institute of Technology, Haifa, Israel.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32558928

Citation

Salameh, Maram, et al. "Stroke and Bleeding Risks in Patients With Atrial Fibrillation Treated With Reduced Apixaban Dose: a Real-Life Study." Clinical Pharmacology and Therapeutics, 2020.
Salameh M, Gronich N, Stein N, et al. Stroke and Bleeding Risks in Patients with Atrial Fibrillation Treated with Reduced Apixaban Dose: A Real-Life Study. Clin Pharmacol Ther. 2020.
Salameh, M., Gronich, N., Stein, N., Kotler, A., Rennert, G., Auriel, E., & Saliba, W. (2020). Stroke and Bleeding Risks in Patients with Atrial Fibrillation Treated with Reduced Apixaban Dose: A Real-Life Study. Clinical Pharmacology and Therapeutics. https://doi.org/10.1002/cpt.1952
Salameh M, et al. Stroke and Bleeding Risks in Patients With Atrial Fibrillation Treated With Reduced Apixaban Dose: a Real-Life Study. Clin Pharmacol Ther. 2020 Jun 19; PubMed PMID: 32558928.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Stroke and Bleeding Risks in Patients with Atrial Fibrillation Treated with Reduced Apixaban Dose: A Real-Life Study. AU - Salameh,Maram, AU - Gronich,Naomi, AU - Stein,Nili, AU - Kotler,Antonio, AU - Rennert,Gad, AU - Auriel,Eitan, AU - Saliba,Walid, Y1 - 2020/06/19/ PY - 2020/03/26/received PY - 2020/06/04/accepted PY - 2020/6/20/pubmed PY - 2020/6/20/medline PY - 2020/6/20/entrez JF - Clinical pharmacology and therapeutics JO - Clin. Pharmacol. Ther. N2 - The purpose of this study was to assess the association between reduced apixaban dose and two outcomes: ischemic stroke/systemic embolism (SE) and major bleeding. We performed a retrospective cohort study within the database of the largest healthcare provider in Israel. We identified all patients diagnosed with atrial fibrillation, who started apixaban treatment between 2013 and 2017. Apixaban users were classified into three dosing regimen groups based on their renal function, age, and weight: standard dose (5 mg b.i.d.), adjusted reduced dose (2.5 mg b.i.d.), and underdosing (2.5 mg b.i.d.). Patients were followed through 2018 for the occurrence of stroke/SE and major bleeding. Of the 27,765 included patients, 13,141 (47%) adequately received standard apixaban dose, 4,739 patients (17%) received adjusted reduced dose, and 9,885 patients (36%) were classified as underdosed. The CHA2DS2-VASc score adjusted hazard ratio for ischemic stroke/SE was 1.1 (95% confidence interval (CI), 0.83-1.43) in the adjusted reduced dose group, and 1.04 (95% CI, 0.83-1.35) in the underdosing group, compared with the standard apixaban dose group. The HAS-BLED score adjusted hazard ratio for any major bleeding was 1.66 (95% CI, 1.32-2.09) in the adjusted reduced dose group, and 1.51 (95% CI, 1.24-1.83) in the underdosing group, compared with apixaban in the standard dose group. Results were similar for major gastrointestinal bleeding and intracranial hemorrhage separately. We conclude that underdosing with apixaban is very common, and may not disproportionately elevate the risk of ischemic stroke. However, albeit halving the dose, patients treated with reduced apixaban dose (adjusted or underdosing) seem to be at higher risk for major bleeding. SN - 1532-6535 UR - https://www.unboundmedicine.com/medline/citation/32558928/Stroke_and_bleeding_risks_in_patients_with_atrial_fibrillation_treated_with_reduced_apixaban_dose:_a_real_life_study L2 - https://doi.org/10.1002/cpt.1952 DB - PRIME DP - Unbound Medicine ER -
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