Zhiyan Liu1,2, Qiufen Xie1, Qian Xiang1,2, Hanxu Zhang1, Guangyan Mu1, Zinan Zhao3, Taotao Hu4, Tingting Wu5, Na Wang6, Jinhua Zhang5, Yan Qian6, Shuang Zhou1, Zining Wang1, Jie Jiang7, Yatong Zhang3, Hongtao Song4, Yimin Cui1,2. 1. Department of Pharmacy, Peking University First Hospital, Beijing, China. 2. School of Pharmaceutical Sciences, Peking University Health Science Center, Beijing, China. 3. Department of Pharmacy, Beijing Hospital, Beijing, China. 4. Department of Pharmacy, 900 Hospital of the Joint Logistics Team, Fuzhou, China. 5. Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, China. 6. Department of Pharmacy, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China. 7. Department of Cardiology, Peking University First Hospital, Beijing, China.
Abstract
BACKGROUND: The data of anti-FXa-IIa activity detection in Asian population is insufficient, and its potential role for drug adherence evaluation in patients with direct oral anticoagulants (DOACs) remains unclear. This study carried out multi-center anti-FXa-IIa activity detection in Asian, aiming to explore its applicability in Asian population and find its role in adherence evaluation. METHODS: We assessed patients' self-reported adherence using the Morisky, Green, and Levine Adherence Scale (MGLS) from six hospitals. Plasma samples were collected for peak and trough concentration determination, and anti-FXa-IIa chromogenic assay was conducted using rivaroxaban/dabigatran calibrators and controls. Multivariate logistic regression models, covariate adjustment and spearman's two-tailed test were conducted in the data analysis. This study had been registered in clinical trials (NCT03666962). RESULTS: In total, 271 patients taking rivaroxaban (n=149) or dabigatran (n=122) were enrolled. Among the 271 patients assessed by MGLS questionnaire, 188 persons (69.4%) showed high adherence, 77 persons (28.4%) was in intermediate adherence group, and only 6 patients (2.2%) had low adherence. Patients are more adherent dosed once daily of rivaroxaban compared to twice daily of dabigatran: 75.6% vs. 63.6%. Anti-FXa-IIa activity had good linear correlation with routine coagulation indexes (P<0.001), but no significant association was found between drug adherence and anti-FXa-IIa activity (P>0.05). CONCLUSIONS: This study confirms that anti-FXa-IIa activity detection based on target drug calibrations can be used as an effective index for pharmacodynamic evaluation in Asian population, but had limited value in drug adherence evaluation for DOACs. As the limited samples, these findings could serve as a hypothesis-generating effort, and should be validated in further studies with larger sample sizes. 2020 Cardiovascular Diagnosis and Therapy. All rights reserved.
BACKGROUND: The data of anti-FXa-IIa activity detection in Asian population is insufficient, and its potential role for drug adherence evaluation in patients with direct oral anticoagulants (DOACs) remains unclear. This study carried out multi-center anti-FXa-IIa activity detection in Asian, aiming to explore its applicability in Asian population and find its role in adherence evaluation. METHODS: We assessed patients' self-reported adherence using the Morisky, Green, and Levine Adherence Scale (MGLS) from six hospitals. Plasma samples were collected for peak and trough concentration determination, and anti-FXa-IIa chromogenic assay was conducted using rivaroxaban/dabigatran calibrators and controls. Multivariate logistic regression models, covariate adjustment and spearman's two-tailed test were conducted in the data analysis. This study had been registered in clinical trials (NCT03666962). RESULTS: In total, 271 patients taking rivaroxaban (n=149) or dabigatran (n=122) were enrolled. Among the 271 patients assessed by MGLS questionnaire, 188 persons (69.4%) showed high adherence, 77 persons (28.4%) was in intermediate adherence group, and only 6 patients (2.2%) had low adherence. Patients are more adherent dosed once daily of rivaroxaban compared to twice daily of dabigatran: 75.6% vs. 63.6%. Anti-FXa-IIa activity had good linear correlation with routine coagulation indexes (P<0.001), but no significant association was found between drug adherence and anti-FXa-IIa activity (P>0.05). CONCLUSIONS: This study confirms that anti-FXa-IIa activity detection based on target drug calibrations can be used as an effective index for pharmacodynamic evaluation in Asian population, but had limited value in drug adherence evaluation for DOACs. As the limited samples, these findings could serve as a hypothesis-generating effort, and should be validated in further studies with larger sample sizes. 2020 Cardiovascular Diagnosis and Therapy. All rights reserved.
Entities:
Keywords:
Direct oral anticoagulants (DOACs); anti-FXa-IIa activity; drug adherence
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