Key result
PPI/H2 RA use did not reduce gastrointestinal bleeding in dabigatran users (6.5% vs 2.6%, P=0.184), whereas prior GIB (OR 25.14) and HAS-BLED ≥3 (OR 5.85) were independent risk factors.
Why the study?
Does PPI/H2RA use prevent gastrointestinal bleeding in patients with atrial fibrillation taking dabigatran?
Cohort (n=247)
Does PPI/H2RA use prevent gastrointestinal bleeding in patients with atrial fibrillation taking dabigatran?
Absolute Event Rate: 6.5% vs 2.6%
p-value: p=.184
In patients with atrial fibrillation taking dabigatran, PPI/H2RA use did not significantly reduce gastrointestinal bleeding, whereas prior GIB and a HAS-BLED score ≥3 were strong independent risk factors.
May warrant closer monitoring for dabigatran users with HAS-BLED ≥3 or recent GIB; leaves open targeted prevention strategies.
Introduction Dabigatran, as compared with warfarin, was associated with lower rates of stroke and systemic embolism with similar rates of major hemorrhage. But it has a significantly higher risk of gastrointestinal bleeding ( GIB ). There are limited data on how to prevent GIB from dabigatran and what are the risk factors. Methods We performed a retrospective cohort study of patients with atrial fibrillation who have ever taken dabigatran for thromboprophylaxis from October 2010 to February 2013. Results A total of 247 patients were identified. There were 10 (4%) patients who developed GIB (6 (6.5%) in PPI /H2 RA users vs 4 (2.6%) in non‐ PPI /H2 RA users; P = .184). History of GIB within 1 year prior to dabigatran initiation and HAS ‐ BLED score ≥3 are independent risk factors for GIB , with odds ratio of 25.14 (95% CI , 2.85‐221.47; P < .01) and 5.85 (95% CI , 1.31‐26.15; P = .021), respectively. Conclusion In this real‐world cohort, PPI /H2 RA use was not associated with reduced GIB events. HAS ‐ BLED score ≥3 and prior history of GIB within 1 year are independent risk factors for GIB among dabigatran users.
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Nantsupawat et al. (2017) conducted a cohort in atrial fibrillation (n=247). PPI/H2 RA use vs. non-PPI/H2 RA users was evaluated on gastrointestinal bleeding (GIB) (p=.184). PPI/H2 RA use did not reduce gastrointestinal bleeding in dabigatran users (6.5% vs 2.6%, P=0.184), whereas prior GIB (OR 25.14) and HAS-BLED ≥3 (OR 5.85) were independent risk factors.
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