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Gastroprotective agents reduce risk for Pradaxa-related GI bleeding
Use of gastroprotective agents was found to be associated with a reduced risk for gastrointestinal bleeding among patients in the Hong Kong population taking Pradaxa in a recent study.
Aiming to determine the risk for GI bleeding and the effects of gastroprotective agents (including proton pump inhibitors and histamine type-2-receptor antagonists) in patients taking Pradaxa (dabigatran, Boehringer Ingelheim) researchers performed a large population-based retrospective cohort study using medical records from a Hong Kong Hospital Authority database.
They identified 5,041 patients (mean age, 72 ± 10.9 years; 47.8% male) newly prescribed dabigatran from 2010 through 2013, and assessed the risk for GI bleeding after adjusting for patient characteristics, comorbidities and concurrent medications. The mean follow-up period was 215 ± 255 days and total follow-up was 2,973 patient-years.
They found 2.5% of patients developed GI bleeding (overall incidence, 4.2 per 100 patient-years). A higher risk for GI bleeding was observed in patients aged 75 years and older (IRR = 2.47; 95% CI, 1.66-3.68), patients with a history of peptic ulcer or GI bleeding (IRR = 2.31; 95% CI, 1.54-3.46) and patients who used aspirin concomitantly (IRR = 1.52; 95% CI, 1.03-2.24).
A 48% lower risk for GI bleeding was found to be associated with concomitant use of gastroprotective agents (IRR = 0.52; 95% CI, 0.35-0.77), including both proton pump inhibitors (IRR = 0.53; 95% CI, 0.31-0.91) and histamine type-2-receptor antagonists (IRR = 0.61; 95% CI, 0.4-0.94), though this lower risk was only significant for upper GI bleeding (IRR = 0.29; 95% CI, 0.15-0.54) and patients with a prior history of peptic ulcer or GI bleeding (IRR = 0.14; 95% CI, 0.06-0.3).
The researchers concluded that “gastroprotective agents should be considered in high-risk patients taking dabigatran. Further prospective randomized clinical trials are warranted to confirm the effect of gastroprotective agents on reducing the risk of [GI bleeding] in patients using dabigatran.” – by Adam Leitenberger
Disclosures: Chan reports she has received research support from Bristol-Myers Squibb and Janssen. Please see the full study for a list of all other researchers’ relevant financial disclosures.