Abstract
Purpose
Patients treated with warfarin must adhere to frequent monitoring, dietary restrictions, and complicated dose adjustments. Apixaban, a direct factor Xa inhibitor, is an alternative to warfarin that may reduce patient burdens associated with warfarin therapy. However, there is limited evidence pertaining to patient satisfaction with anticoagulant therapies in Japanese patients. The purpose of this observational study was to investigate changes in patient satisfaction after switching from warfarin to apixaban.
Patients and methods
Nonvalvular atrial fibrillation (NVAF) patients who were scheduled to switch anticoagulants from warfarin to apixaban were enrolled and treated with apixaban for 12 weeks. Patient satisfaction was assessed before the change in medication and after 12 weeks of treatment with apixaban using the Anti-Clot Treatment Scale (ACTS), a patient-reported instrument for measuring satisfaction with anticoagulation treatment. The ACTS includes a 12-item burden scale (maximum 60 points) and a 3-item benefit scale (maximum 15 points).
Results
Among 732 NVAF patients enrolled, the full analysis set consisted of 697 patients who completed two ACTS assessments (one before the medication change and one 12 weeks after the change). Mean (±standard deviation) patient age was 76.2±9.1 years and mean CHADS2 score was 2.5±1.3. There were no significant changes in ACTS benefit scores. However, ACTS burden scores showed significant improvements at Week 12 compared to baseline (55.6±5.3 at Week 12 and 49.7±8.7 at baseline; P<0.0001). Factors associated with changes in ACTS burden scores from the multiple logistic regression analysis were age ≥70 years (odds ratio [OR]: 1.86; 95% confidence interval [CI]: 1.12–3.10; P=0.0169), baseline ACTS burden score (OR: 0.79; 95% CI: 0.75–0.82; P<0.0001), and use of non-steroidal anti-inflammatory drugs/antiplatelet drugs (OR: 0.60; 95% CI: 0.36–1.00; P=0.0499).
Conclusion
Switching from warfarin to apixaban improved patient satisfaction with anticoagulant therapy in Japanese patients with NVAF by reducing burden of treatment.
Acknowledgments
The authors thank the doctors who participated in this study (see Table S7 for details). We would like to acknowledge the contribution of Mebix, Inc. to this study including site selection, site monitoring, study management, and data management, and DOT WORLD Co., Ltd. for developing the EDC. We sincerely appreciate MediStatLab Co., Ltd. for its contributions to statistical analysis. We thank Ms. Pearl Gomes from Cactus Communications K.K. for editing the manuscript. This study and editing of the manuscript were supported by Bristol-Myers Squibb K.K and Pfizer Japan Inc.
Author contributions
YK, TI, KK, TH, and MY were involved in designing the study, interpreting the obtained results, and critically reviewing the drafted manuscript. MK was involved in designing the study, managing the project, interpreting the obtained results, and critically reviewing the drafted manuscript. MC and MI were involved in designing the study, preparing a statistical analysis plan, managing the project, interpreting the obtained results, and drafting the manuscript. All authors contributed toward data analysis, drafting and revising the paper and agree to be accountable for all aspects of the work.
Disclosure
YK received honoraria and consulting fees (for speaker, writer, and/or adviser) from Bayer Yakuhin Ltd., Bristol-Myers Squibb K.K., Daiichi Sankyo K.K., Nippon Boehringer Ingelheim, and Pfizer Japan Inc., and research grants from Daiichi Sankyo K.K. and Nippon Boehringer Ingelheim. TI received research grants from Bristol-Myers Squibb K.K., Daiichi Sankyo K.K., and Nippon Boehringer Ingelheim, and honoraria and consulting fees from Bayer Yakuhin Ltd., Bristol-Myers Squibb K.K., Daiichi Sankyo K.K., Nippon Boehringer Ingelheim, and Pfizer Japan Inc. KK received research grants from Bayer Yakuhin Ltd., Daiichi Sankyo K.K., and Nippon Boehringer Ingelheim, and honoraria and consulting fees from Bayer Yakuhin Ltd., Daiichi Sankyo K.K., Nippon Boehringer Ingelheim, and Pfizer Japan Inc. TH received honoraria and consulting fees from Bayer Yakuhin Ltd., Bristol-Myers Squibb K.K., Daiichi Sankyo K.K., Nippon Boehringer Ingelheim, and Pfizer Japan Inc. MY received a research grant from Nippon Boehringer Ingelheim and honoraria and consulting fees from Bayer Yakuhin Ltd., Bristol-Myers Squibb K.K., Daiichi Sankyo K.K., Nippon Boehringer Ingelheim, and Pfizer Japan Inc. MK is an employee of Bristol-Myers Squibb K.K. MC and MI are employees of Pfizer Japan Inc. The authors report no other conflicts of interest in this work.