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GI Bleeding Risk Linked to Oral Anticoagulants Increased with Age
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PHILADELPHIA — Compared with warfarin, gastrointestinal bleeding risk associated with the novel oral anticoagulants dabigatran and rivaroxaban increased with age, according to data presented at the ACG Annual Scientific Meeting.
Novel oral anticoagulants (NOACs) such as dabigatran (Pradaxa, Boehringer Ingelheim) and rivaroxaban (Xarelto, Janssen Pharmaceuticals) have “had a rapid uptake in the community … despite the fact that the randomized controlled trials did show an unexpected increase in GI bleeding, especially among patients greater than the age of 75, and a subsequent meta-analysis suggested that risk could be up to 25%,” Neena S. Abraham, MD, of the Mayo Clinic, said in a presentation. “Our objective was to quantify risk of total upper and lower GI bleed risk associated with dabigatran and rivaroxaban and compare that risk to that of warfarin.”
Neena S. Abraham
Using national database records from November 2010 to September 2013, Abraham and colleagues performed a retrospective study comparing risk for GI bleeding in patients with and without atrial fibrillation (AF) who used NOACs or warfarin. New users of dabigatran (n=9,860) and rivaroxaban (n=20,619) were each compared with an equal number of new warfarin users.
In AF and non-AF patients who received dabigatran, crude incidence rate for related GI bleeding was 2.32/100 and 3.11/100 patient-years, respectively. In AF and non-AF patients who received rivaroxaban, the rate was 2.91/100 and 1.63/100 patient-years, respectively. Rivaroxaban was more likely to be prescribed to non-AF patients and overall risk for GI bleed tended to be lower (HR=0.71; 95% CI, 0.49-1.03), whereas dabigatran was associated with lower risk in AF patients (HR=0.76; 95% CI, 0.58-0.99). Both NOACs were associated with GI bleeding risk that increased with age older than 65 years, and which exceeded the risk associated with warfarin by age 75 years.
“Our study is the first to evaluate GI safety in NOACs compared to warfarin in a real-world multi-age setting, and our data does provide evidence to facilitate risk–benefit consideration of multiple treatment options by patients and their providers,” Abraham said. “Our data does suggest, however, that although there is general safety among oral anticoagulants among younger patients, GI safety concerns do exist when they are used among the elderly.”
For more information:
Abraham NS. Abstract 43. Presented at: ACG Annual Scientific Meeting; Oct. 17-22, 2014; Philadelphia.
Disclosure: The researchers report no relevant financial disclosures.