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Gastrointestinal bleeding with dabigatran, a comparative study with warfarin: a multicenter experience
Insights
Dabigatran showed a lower risk of gastrointestinal bleeding compared to warfarin. Key risk factors for dabigatran-related bleeding include the initial 100 days of treatment, older age, and prior bleeding history.
Area of Science:
- Pharmacology and Therapeutics
- Clinical Medicine
- Gastroenterology
Background:
- The comparative risk of gastrointestinal (GI) bleeding between dabigatran and warfarin remains a subject of debate.
- Previous studies have yielded controversial findings regarding this safety profile.
Purpose of the Study:
- To evaluate and compare the incidence of GI bleeding in patients treated with dabigatran versus warfarin.
- To identify specific risk factors associated with GI bleeding in patients taking dabigatran.
Main Methods:
- A retrospective review of medical records for patients initiated on dabigatran or warfarin between October 2010 and October 2012.
- Data were collected from two hospital settings, including 417 patients (208 on dabigatran, 209 on warfarin).
Main Results:
- Dabigatran was associated with a significantly lower rate of GI bleeding (4.8%) compared to warfarin (10.1%; p=0.0375).
- For dabigatran users, the first 100 days of therapy (p=0.0007), age over 65 (p=0.0453), and a history of GI bleeding (p=0.036) were identified as significant risk factors.
- The lower GI tract was the predominant site of bleeding in the dabigatran group (80.0%).
Conclusions:
- Dabigatran demonstrates a reduced risk of GI bleeding compared to warfarin.
- Early treatment duration (≤100 days), advanced age (>65 years), and a prior GI bleeding history are critical risk factors for dabigatran-associated GI bleeding.
Background/Aims:
The risk of gastrointestinal (GI) bleeding with dabigatran when compared to warfarin has been controversial in the literature. The aim of our study was to assess this risk with the use of dabigatran.
Methods:
We examined the medical records of patients who were started on dabigatran or warfarin from October 2010 to October 2012. The study was conducted in two hospitals.
Results:
A total of 417 patients were included (208 dabigatran vs. 209 warfarin). GI bleeding occurred in 10 patients (4.8%) in the dabigatran group compared to 21 patients (10.1%) in the warfarin group (p=0.0375). Multivariate analysis showed that patients who were on dabigatran for ≤ 100 days had a higher incidence of GI bleeding than those who were on it for >100 days (p=0.0007). The odds of GI bleeding in patients who were on dabigatran for ≤ 100 days was 8.2 times higher compared to those who were on the drug for >100 days. The incidence of GI bleeding in patients >65 years old was higher than in those <65 years old (p=0.0453, OR=3). History of previous GI bleeding was another risk factor for GI bleeding in the dabigatran group (p=0.036, OR=6.3). The lower GI tract was the most common site for GI bleeding in the dabigatran group (80.0% vs. 38.1%, p=0.014).
Conclusions:
The risk of GI bleeding was lower with dabigatran. The risk factors for GI bleeding with dabigatran were the first 100 days, age >65 years, and a history of previous GI bleeding.
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