Chinese Journal of Pharmacovigilance ›› 2018, Vol. 15 ›› Issue (12): 705-708.

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Assessment of Rationality, Safety and Adherence of Dabigatran in Patients with Nonvalvular Atrial Fibrillation

YANG Yuhui, LUO Zhurong, ZHENG Weixing, HUANG Mingfang, LIN Yi, CAO Xiaozhi, ZHANG Wenli   

  1. Department of Cardiology, Fuzhou General Hospital of People's Liberation Army; Fuzhou General Hospital of Fujian Medical University; Fuzhou General Hospital of Fujian Traditional Chinese Medical University, Fujian Fuzhou 350000, China
  • Received:2019-01-18 Revised:2019-01-18 Online:2018-12-20 Published:2019-01-18

Abstract: Objective To analyze the rationality of dabigatran application in the patients with nonvalvular atrial fibrillation(NVAF), as well as the safety and adherence, so as to better guide clinical therapy and obtain foundation for further research. Methods A retrospective research was conducted on patients with NVAF who were given dabigatran from January 2016 to January 2018. The rationality, safety and adherence of dabigatran application were evaluated by retrospective cases analysis and telephone follow-up method. Results A total of 109 patients (average age 68.26±10.82, average CHA2DS2-VASc score 3.21±1.30, average HAS-BLED score 1.38±1.02)were enrolled. 9 patients had a CHA2DS2-VASc score=0, 3 of them had no indication of anticoagulant therapy. 91 patients were given dabigatran of 110 mg. 18 patients were given dabigatran of 150 mg and 5 of their dosage were unsuitable. 4 patients had wrong frequency of dosage. 13 patients had adverse reactions. 34 patients changed their anticoagulant and 41.18% of them had unreasonable international normalized ratio (INR). 16 patients were given amiodarone at the same time and 7 of them had no regular follow-up. 11 patients stopped taking pills and 7 of them had no doctors' instructions. 15.60% of the patients had no regular follow-up. 43.12% of the patients didn't test their urine occult blood regularly. Conclusion Dabigatran has good safety and adherence with some adverse reactions. Part of the patients paid inadequate attention to the risk and had no regular follow-up. Medication education according to guidelines is necessary to improve the safety and adherence of dabigatran application.

Key words: nonvalvular atrial fibrillation, dabigatran, rationality, safety, adherence

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