title: Identification and management of noncompliance in atrial fibrillation patients receiving dabigatran: the role of a drug monitor.
abstract: BACKGROUND
  Noncompliant patients might be at risk of thromboembolism because of the short half-life and rapid offset of dabigatran etexilate. The assessment and management of dabigatran noncompliance should be optimized.
  
  
  RESULTS
  A total of 150 nonvalvular atrial fibrillation patients receiving dabigatran were prospectively enrolled and followed for drug compliance and persistence. Noncompliance was identified by questionnaires and interviews. The hemoclot thrombin inhibitor (HTI) assay was used for monitoring the plasma dabigatran levels. Sixteen patients were noncompliant (10.7%). None of the clinical characteristics were significantly relevant to noncompliance after multivariate analysis. The dabigatran plasma level based on HTI was the only independent predictor of noncompliance (odds ratio: 0.97 per ng/mL, P = 0.003). The prothrombin time (PT), international normalized ratio of PT (INR [PT]), and activated partial thromboplastin time did not differ between compliant and noncompliant patients. During the follow-up, the persistent prescription of dabigatran was noted in 75% of noncompliant patients without improvement in compliance. The drug discontinuation rate was higher in the noncompliant than compliant patients (6.7% vs. 25%, P = 0.035). None of the patients in either group received warfarin after discontinuing dabigatran.
  
  
  CONCLUSIONS
  The assessment and management of dabigatran noncompliance is generally ignored in clinical practice. The measurement of dabigatran plasma levels by HTI could be a reliable and simple method to identify noncompliant patients.
authors.affiliation: Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan; Institute of Clinical Medicine and Cardiovascular Research Institute, National Yang-Ming University, Taipei, Taiwan.
authors.forename: Yu-Feng
authors.initials: YF
authors.lastname: Hu
authors.forename: Jo-Nan
authors.initials: JN
authors.lastname: Liao
authors.forename: Chang-Ming
authors.initials: CM
authors.lastname: Chern
authors.forename: Ching-Hui
authors.initials: CH
authors.lastname: Weng
authors.forename: Yenn-Jiang
authors.initials: YJ
authors.lastname: Lin
authors.forename: Shih-Lin
authors.initials: SL
authors.lastname: Chang
authors.forename: Cheng-Hsueh
authors.initials: CH
authors.lastname: Wu
authors.forename: Shih-Hsien
authors.initials: SH
authors.lastname: Sung
authors.forename: Kang-Ling
authors.initials: KL
authors.lastname: Wang
authors.forename: Tse-Min
authors.initials: TM
authors.lastname: Lu
authors.forename: Tze-Fan
authors.initials: TF
authors.lastname: Chao
authors.forename: Li-Wei
authors.initials: LW
authors.lastname: Lo
authors.forename: Fa-Po
authors.initials: FP
authors.lastname: Chung
authors.forename: Li-Chi
authors.initials: LC
authors.lastname: Hsu
authors.forename: Shih-Ann
authors.initials: SA
authors.lastname: Chen
mesh_terms: D000368:Aged; D000991:Antithrombins / Q000097:blood / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000097:blood* / Q000150:complications / Q000188:drug therapy; D000069604:Dabigatran / Q000097:blood* / Q000627:therapeutic use*; D016903:Drug Monitoring / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D055118:Medication Adherence; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013923:Thromboembolism / Q000097:blood* / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000991:Antithrombins; D000069604:Dabigatran
keywords: atrial fibrillation; compliance; dabigatran