Gastrointestinal Bleeding Associated with Dabigatran or Rivaroxaban Is Similar to That Associated with Warfarin
Paul S. Mueller, MD, MPH, FACP reviewing Chang H-Y et al. BMJ 2015 Apr 24. Abraham NS et al. BMJ 2015 Apr 24. Vaughan Sarrazin MS and Rose A. BMJ 2015 Apr 24.
Nonetheless, clinicians should be cautious when prescribing novel anticoagulants to elders and patients with renal impairment.
In randomized trial of treatment for atrial fibrillation, the novel oral anticoagulants, dabigatran (Pradaxa) and rivaroxaban (Xarelto), were associated with slightly higher risk for gastrointestinal (GI) bleeding than did warfarin (NEJM JW Gen Med Feb 1 2014 and Lancet 2014; 383:955); in trials of treatment for thromboembolism, GI bleeding risks with novel anticoagulants and warfarin were similar (NEJM JW Gen Med Jan 1 2015 and Blood 2014; 124:1968). But how is this playing out in real-world use?
In a retrospective study, researchers used a large administrative database of commercially insured patients and compared risk for GI bleeding among 46,000 new adult users of dabigatran, rivaroxaban, and warfarin. After adjusting for multiple potential confounders, the investigators found no statistically significant differences in risks for GI bleeding between either dabigatran or rivaroxaban use and warfarin use.
In a similar study that included propensity matching, researchers compared risk for GI bleeding among 93,000 new adult users of these anticoagulants. Risks for GI bleeding associated with dabigatran and rivaroxaban were similar to that associated with warfarin in both patients with atrial fibrillation (AF) and those without AF. Notably, risk for GI bleeding increased at a faster rate with increasing age among novel anticoagulant users than among warfarin users, especially among the oldest patients (age, >75).
Citation(s):
Chang H-Y et al. Risk of gastrointestinal bleeding associated with oral anticoagulants: Population based retrospective cohort study. BMJ 2015 Apr 24; 350:h1585.
Abraham NS et al. Comparative risk of gastrointestinal bleeding with dabigatran, rivaroxaban, and warfarin: Population based cohort study. BMJ 2015 Apr 24; 350:h1857.
Vaughan Sarrazin MS and Rose A.Safety of new oral anticoagulants. BMJ 2015 Apr 24; 350:h1679.
