title: Anticoagulant-related gastrointestinal bleeding--could this facilitate early detection of benign or malignant gastrointestinal lesions?
abstract: BACKGROUND
  The higher incidence of gastrointestinal (GI) bleeding with the non-vitamin K oral anticoagulants (NOACs) may be related to pre-existing malignancies; diagnostic measures triggered by these bleedings could lead to early detection of these malignancies.
  
  
  METHODS
  We retrieved the preferred terms on GI bleeding and GI cancer reported as adverse events (AEs) from phase III studies in patients with atrial fibrillation for each NOAC on ClinicalTrials.gov . We also analyzed the RE-LY trial database.
  
  
  RESULTS
  From ClinicalTrials.gov , AE-GI bleeding incidence was: dabigatran 110 mg b.i.d. (D110: 1.42% versus 1.37%), dabigatran 150 mg b.i.d. (D150: 1.93% versus 1.37%), rivaroxaban (3.52% versus 2.68%), and apixaban (1.93% versus 1.59%), compared with warfarin, respectively. The incidence of AE-GI cancer was similar between the NOACs (D110 [0.79%], D150 [0.61%], rivaroxaban [0.83%], and apixaban [0.69%]), but numerically higher compared with warfarin (0.37%; 0.73%; 0.57%, respectively). In the RE-LY database, the same pattern was seen for dabigatran, with an association between GI bleeding and GI cancer diagnosis.
  
  
  CONCLUSIONS
  Anticoagulant-related GI bleeding may represent the unmasking of pre-existing malignancies leading to increased detection of GI cancer. This may be especially in the first month of treatment and could explain the numerically higher numbers of GI malignancies observed with NOACs.
authors.affiliation: Center for Thrombosis and Hemostasis, University Medical Center , Mainz , Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Clemens
authors.forename: Andreas
authors.initials: A
authors.lastname: Strack
authors.forename: Herbert
authors.initials: H
authors.lastname: Noack
authors.forename: Stavros
authors.initials: S
authors.lastname: Konstantinides
authors.forename: Martina
authors.initials: M
authors.lastname: Brueckmann
authors.forename: Gregory Y H
authors.initials: GY
authors.lastname: Lip
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects*; D001281:Atrial Fibrillation / Q000188:drug therapy; D001562:Benzimidazoles / Q000008:administration & dosage / Q000009:adverse effects; D017326:Clinical Trials, Phase III as Topic; D000069604:Dabigatran; D055088:Early Detection of Cancer; D006471:Gastrointestinal Hemorrhage / Q000453:epidemiology* / Q000209:etiology*; D005770:Gastrointestinal Neoplasms / Q000150:complications / Q000175:diagnosis* / Q000453:epidemiology*; D006801:Humans; D015994:Incidence; D009025:Morpholines / Q000009:adverse effects; D011720:Pyrazoles / Q000009:adverse effects; D011728:Pyridones / Q000009:adverse effects; D012189:Retrospective Studies; D000069552:Rivaroxaban; D013876:Thiophenes / Q000009:adverse effects; D014859:Warfarin / Q000009:adverse effects; D015091:beta-Alanine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives
chemical_list: D000925:Anticoagulants; D001562:Benzimidazoles; D009025:Morpholines; D011720:Pyrazoles; D011728:Pyridones; D013876:Thiophenes; D015091:beta-Alanine; C522181:apixaban; D014859:Warfarin; D000069552:Rivaroxaban; D000069604:Dabigatran
keywords: Anticoagulants; gastrointestinal hemorrhage; gastrointestinal neoplasms; non-vitamin K oral anticoagulants