Risk of Gastrointestinal Bleeding with Dabigatran: A Head-to-Head Comparative Study with Rivaroxaban

Abstract

Introduction: The risk of gastrointestinal (GI) bleeding of dabigatran and rivaroxaban is relatively unexplored. The aim of our study was to compare this risk in both drugs. Methods: We examined the medical records of patients on either dabigatran or rivaroxaban from October 2010 to April 2013 in two hospitals. Results: A total of 374 patients (147 rivaroxaban vs. 227 dabigatran) were identified. GI bleeding occurred in 5.3% in the dabigatran when compared to 4.8% in the rivaroxaban group (p = 0.8215). Multivariate analysis showed that the odds of GI bleeding while on dabigatran for ≤40 days when compared to ≥40 days was 8.3 (p < 0.0001). In the rivaroxaban group, patients who were on the drug for ≤40 days had a higher incidence of bleeding when compared to those >40 days (OR = 2.8, p = 0.023). Concomitant use of antiplatelets (single or dual) or non-steroidal anti-inflammatory drugs was not associated with increased bleeding in the dabigatran group; however, the use of dual antiplatelet agents with rivaroxaban was associated with an increased risk of GI bleeding (OR = 7.4, p = 0.0378). Prior GI bleeding had a higher risk of bleeding in the rivaroxaban group (OR = 15.5, p = 0.0002). Conclusion: Dabigatran was not associated with a higher incidence of GI bleeding. Both drugs had a higher bleeding risk in the first 40 days.

High Cost of Hospitalization for Colonic Diverticular Bleeding Depended on Repeated Bleeding and Blood Transfusion: Analysis with Diagnosis Procedure Combination Data in Japan

“…Various risk factors for colonic diverticular bleeding have been reported, including the use of nonsteroidal anti-inflammatory drugs (NSAIDs), antiplatelet drugs, concomitant arteriosclerotic diseases, such as hypertension and diabetes mellitus, and cardiovascular and cerebrovascular diseases [3,4,5,6,7,8]. Female sex, warfarin use, and chronic kidney disease reportedly increase the risk of a transfusion requirement, while advanced age and NSAID use increase the risk of prolonged hospitalization [9,10]. Colonoscopy is applied for both diagnosis and treatment of colonic diverticular bleeding.…”

Comparing Stroke and Bleeding with Rivaroxaban and Dabigatran in Atrial Fibrillation: Analysis of the US Medicare Part D Data

“…[16] However, the authors used medical records from only two hospitals and did not examine the risk of bleeding by dose of anticoagulant separately. [16] Because the risk of bleeding varies by the strength of anticoagulant, it is also necessary to separately examine the risk of bleeding by dose.…”

Bleeding outcomes associated with rivaroxaban and dabigatran in patients treated for atrial fibrillation: a systematic review and meta-analysis

“…In addition, another study including 556 consecutive patients showed both drug rivaroxaban and dabigatran to be effective and safe compared to warfarin [11]. Another head-to-head comparison on the other hand showed dabigatran and rivaroxaban to have a higher bleeding risk in the first 40 days, but dabigatran was not associated with an increased risk of GI bleeding [12]. …”