Literature DB >> 25995392

Risk of gastrointestinal adverse effects of dabigatran compared with warfarin among patients with atrial fibrillation: a nationwide cohort study.

Laila Staerk1, Gunnar H Gislason2, Gregory Y H Lip3, Emil L Fosbøl4, Morten Lock Hansen5, Morten Lamberts6, Anders Nissen Bonde5, Christian Torp-Pedersen7, Jonas Bjerring Olesen5.   

Abstract

AIMS: To examine the risk of gastrointestinal adverse effects associated with dabigatran use compared with warfarin among patients with atrial fibrillation (AF). METHODS AND
RESULTS: Patients with AF and no history of gastrointestinal diseases initiating dabigatran or warfarin were identified from Danish nationwide registries from 22 August 2011 until 31 December 2012. Patients were classified as naive or experienced users, according to prior use of oral anticoagulant (OAC) therapy. The risk of subsequent proton pump inhibitor (PPI) use, upper dyspepsia-like diagnoses (gastroesophageal reflux, gastritis, gastric, and duodenal ulcer) and gastrointestinal bleeding requiring hospitalization, gastroscopy, and discontinuation of dabigatran and warfarin was examined by cumulative incidence rates and multivariable adjusted Cox regression models. We identified five groups: OAC-naive warfarin (n = 4534); OAC-naive dabigatran 110 mg b.i.d. (dabigatran 110) (n = 1168); OAC-naive dabigatran 150 mg b.i.d. (dabigatran 150) (n = 1844); OAC-experienced dabigatran 110 (n = 1143); and OAC-experienced dabigatran 150 (n = 1748). Compared with OAC-naive warfarin, the rate of initiating PPIs was significantly increased for OAC-naive dabigatran 110 [hazard ratio (HR), 1.24; 95% confidence interval (CI), 1.02-1.50]. Other dabigatran regimes were not associated with a higher risk of initiating PPIs, upper dyspepsia-like diagnoses, gastrointestinal bleeding, or gastroscopy. The risk of discontinuation was increased for OAC-experienced dabigatran 150 (HR, 1.13; 95% CI, 1.02-1.25), but not for the other dabigatran-treated groups, relative to OAC-naive warfarin.
CONCLUSION: Dabigatran was not associated with upper dyspepsia-like diagnoses or gastrointestinal bleeding requiring hospitalization, and gastroscopy. The risk of subsequent PPI use was increased for OAC-naive dabigatran 110 mg users, and the risk of discontinuation was increased for OAC-experienced dabigatran 150 mg users. Published on behalf of the European Society of Cardiology. All rights reserved.
© The Author 2015. For permissions please email: journals.permissions@oup.com.

Entities:  

Keywords:  Discontinuation; Dyspepsia; Gastrointestinal bleeding; Non-vitamin K antagonist oral anticoagulant; Oral anticoagulation; Proton pump inhibitors

Mesh:

Substances:

Year:  2015        PMID: 25995392     DOI: 10.1093/europace/euv119

Source DB:  PubMed          Journal:  Europace        ISSN: 1099-5129            Impact factor:   5.214


  6 in total

Review 1.  The association between non-vitamin K antagonist oral anticoagulants and gastrointestinal bleeding: a meta-analysis of observational studies.

Authors:  Ying He; Ian C K Wong; Xue Li; Shweta Anand; Wai K Leung; Chung Wah Siu; Esther W Chan
Journal:  Br J Clin Pharmacol       Date:  2016-04-15       Impact factor: 4.335

2.  Objective Evaluation of Gastroesophageal Reflux Disease in Patients with Paroxysmal Atrial Fibrillation.

Authors:  Enia Lucia Coutinho; Fernando A M Herbella; Carlos Alexandre Volponi Lovato; Marco G Patti; Francisco Schlottmann; Angelo Amato Vincenzo de Paola
Journal:  World J Surg       Date:  2018-05       Impact factor: 3.352

3.  Using the Symmetry Analysis Design to Screen for Adverse Effects of Non-vitamin K Antagonist Oral Anticoagulants.

Authors:  Maja Hellfritzsch; Lotte Rasmussen; Jesper Hallas; Anton Pottegård
Journal:  Drug Saf       Date:  2018-07       Impact factor: 5.606

4.  Assessing Safety of Direct Thrombin Inhibitors, Direct Factor Xa Inhibitors and Vitamin K Antagonists in Patients with Atrial Fibrillation: A Nation-Wide Propensity Score Matched Cohort from Sweden.

Authors:  Marie Linder; Anastasia Iliadou Nyman; Helle Kieler; Bengt Danielsson; Natalia Borg; Marcus Gry; Julius Collin
Journal:  Clin Epidemiol       Date:  2020-10-05       Impact factor: 4.790

5.  Burden of upper gastrointestinal symptoms in patients prescribed dabigatran for stroke prevention.

Authors:  Pak-Hei Chan; Jo-Jo Hai; Duo Huang; Mei-Han Ho; Esther W Chan; Bernard Man-Yung Cheung; Annie On-On Chan; Ian Chi-Kei Wong; Hung-Fat Tse; Ivan Fan-Ngai Hung; Chung-Wah Siu
Journal:  SAGE Open Med       Date:  2016-08-04

Review 6.  Risk-Benefit Profile of Direct-Acting Oral Anticoagulants in Established Therapeutic Indications: An Overview of Systematic Reviews and Observational Studies.

Authors:  Emanuel Raschi; Matteo Bianchin; Walter Ageno; Roberto De Ponti; Fabrizio De Ponti
Journal:  Drug Saf       Date:  2016-12       Impact factor: 5.606

  6 in total

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