Abstract
Objective
To assess the quality of life (QOL) with rivaroxaban in patients with non-valvular atrial fibrilation (NVAF) related to therapeutic compliance.
Methods
Prospective, longitudinal, multicenter study was developed in 160 Spanish primary or specialized care centers. We included 412 patients treated with rivaroxaban, prescribed for stroke prevention. Three visits were conducted: baseline, 6 and 12 months. Compliance was measured by electronic monitoring systems. QOL was measured by a specific questionnaire. We calculated the percentage of compliance means, the percentage of daily compliers and the score of QOL.
Results
Three hundred and seventy patients finished the study (mean age 75.19 SD: 7.5 years). Daily compliance was 83.5% (CI 78.53–88.57%) (n = 309) and 80% (CI 74.65–85.35%) at 6 and 12 months, respectively. Average QOL rating was 112.85 (SD 29.31) in non-compliant and 111.80 (SD 29.31) in the compliant group (p = Not significant), and after 12 months of 124.67 (SD 30.78) and 83.47 (SD 26.44), respectively (p < 0.0001), with a decrease in the score compliers (p < 0.01) and an increase in non-compliant group (p < 0.05). A higher number of drugs consumed, as well as the number of diseases/conditions suffered, the older age of the patients and having been previously treated with VKA were associated with a higher overall score (worse QOL).
Conclusions
QOL in NVAF patients treated with rivaroxaban improved significantly over the study group at the expense of compliers. A worse QOL was associated with pluripathology, polymedication, older patients and previous treatment with VKA.
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Acknowledgements
We would like to thank all the researchers of the CUMRIVAFA and the rest of the team of the SHE-LEHLA Compliance Study Group for their work. We thank to Bayer Hispania SL for their sponsorship in this study.
Funding
This study was funded by Bayer Healthcare (Grant 01-2014). Bayer gave a grant to the Association Medical Group Onuba, Huelva (Spain). This association was the promoter of the study.
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No conflict of interest existed. The authors declare that they have no conflict of interest.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The study was approved by the Clinical Ethics Committee of Andalucía, Elda and Jordi Gol i Gurina Foundation.
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Informed consent was obtained from all individual participants included in the study. File attached informed consent.
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Márquez-Contreras, E., Martell-Claros, N., Gil-Guillén, V. et al. Quality of life with rivaroxaban in patients with non-valvular atrial fibrilation by therapeutic compliance. Qual Life Res 26, 647–654 (2017). https://doi.org/10.1007/s11136-016-1489-x
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DOI: https://doi.org/10.1007/s11136-016-1489-x