title: Burden of upper gastrointestinal symptoms in patients prescribed dabigatran for stroke prevention.
abstract: BACKGROUND
  Dabigatran, a non-vitamin K antagonist oral anticoagulant, has been shown to prevent stroke in patients with non-valvular atrial fibrillation. Nonetheless, studies show that 10%-30% of those prescribed dabigatran experience dyspepsia that may eventually lead to discontinuation of therapy and loss of clinical benefit.
  
  
  OBJECTIVE
  To evaluate the gastrointestinal tolerability of dabigatran utilizing a validated questionnaire, as well as determining subsequent non-compliance and drug discontinuation.
  
  
  METHODS
  This is an observational study. All patients were assessed by a validated questionnaire, Hong Kong dyspepsia index, prior to drug prescription and again 4 weeks later.
  
  
  RESULTS
  In this study, 115 patients with non-valvular atrial fibrillation (mean age: 74.6 ± 11.4 years; mean CHA2DS2-VASc score was 3.39 ± 1.59) were prescribed dabigatran. At baseline, the mean Hong Kong dyspepsia index was 12.9 ± 1.6 and nine patients had significant dyspepsia (Hong Kong dyspepsia index ⩾ 16). After 4 weeks, the mean Hong Kong dyspepsia index was similar at 12.6 ± 1.9 (p = 0.23). There was no change in Hong Kong dyspepsia index after initiation of dabigatran in 59 (51.3%) patients, and improvement in 37 (32.2%). Only 19 (16.5%) patients had worsening of Hong Kong dyspepsia index, and among these 19 patients, only 1 patient (0.9%) discontinued dabigatran due to significant dyspepsia.
  
  
  CONCLUSIONS
  Worsening of dyspepsia with dabigatran 110 mg twice daily was uncommon with correct drug administration and clear instructions provided. Systematic assessment of dyspeptic symptoms using a validated questionnaire (i.e. Hong Kong dyspepsia index) before and after treatment initiation allows a more objective comparison of dyspeptic symptoms.
authors.affiliation: Division of Cardiology, Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.
authors.forename: Pak-Hei
authors.initials: PH
authors.lastname: Chan
authors.affiliation: Division of Cardiology, Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.
authors.forename: Jo-Jo
authors.initials: JJ
authors.lastname: Hai
authors.affiliation: Division of Cardiology, Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.
authors.forename: Duo
authors.initials: D
authors.lastname: Huang
authors.affiliation: Division of Cardiology, Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.
authors.forename: Mei-Han
authors.initials: MH
authors.lastname: Ho
authors.affiliation: Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.
authors.forename: Esther W
authors.initials: EW
authors.lastname: Chan
authors.affiliation: Division of Clinical Pharmacology, Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.
authors.forename: Bernard Man-Yung
authors.initials: BM
authors.lastname: Cheung
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.
authors.forename: Annie On-On
authors.initials: AO
authors.lastname: Chan
authors.affiliation: Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.
authors.forename: Ian Chi-Kei
authors.initials: IC
authors.lastname: Wong
authors.affiliation: Division of Cardiology, Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.
authors.forename: Hung-Fat
authors.initials: HF
authors.lastname: Tse
authors.affiliation: Division of Gastroenterology and Hepatology, Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.
authors.forename: Ivan Fan-Ngai
authors.initials: IF
authors.lastname: Hung
authors.affiliation: Division of Cardiology, Department of Medicine, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong.
authors.forename: Chung-Wah
authors.initials: CW
authors.lastname: Siu
keywords: Dabigatran; atrial fibrillation; upper gastrointestinal symptoms