Rehospitalization Within 30 Days For Serious Bleeding Events Reported With 13% Of Pradaxa Patients Compared To 5% Of Warfarin Patients
Medical researchers recently reviewed population-wide electronic medical records from the Clinical Data Analysis and Reporting System of the Hong Kong Hospital Authority to identify the 30-day readmission rates for patients with nonvalvular atrial fibrillation treated with Pradaxa (dabigatran) or warfarin.
The bottom line for this retrospective cohort study is that the patients treated with Pradaxa appeared to be at higher risk for 30-day hospital readmission due to bleeding.
This September 21, 2017 article, "Dabigatran associated with higher 30-day readmission rate for bleeding than warfarin", reports on some of the findings from this medical study:
Subgroup analyses showed [Pradaxa (dabigatran)] use was associated with higher admission rate with gastrointestinal bleeding (2.9 vs. 2.1 per 100 patient-years; IRR = 2.21; 95% CI, 1.28-3.83) and a lower rate of intracranial hemorrhage (0.5 vs. 1.4 per 100 patient-years; IRR = 0.26; 95% CI, 0.12-0.55).
Post hoc analysis showed an association between [Pradaxa (dabigatran)] use and a lower rate of bleeding among patients aged younger than 75 years (IRR = 0.59; 95% CI, 0.35-0.97) compared with those aged 75 years or older (IRR = 1.29; 95% CI, 0.83–2.01).
Results showed 13.5% of [Pradaxa (dabigatran)]-treated patients and 5.1% of warfarin-treated patients were readmitted to the hospital with bleeding within 30 days of discharge.
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Found below that article is a "Perspective" piece about this Pradaxa-versus-warfarin study written by Thomas J. Moore, of the Institute for Safe Medication Practices. Therein, he adds some contextual information pertinent to the Hong Kong researchers' findings:
... This new study’s annualized hospitalization rates of 5% and 5.8% for [Pradaxa (dabigatran)] and warfarin for bleeding in patients with atrial fibrillation also are consistent with previously published results. However, had this Hong Kong study been conducted in the United States, one would expect even higher hospital admission rates for [Pradaxa (dabigatran)] because the lower 110-mg dose — taken by 75% in this population — was not available in the United States until recently, and is not recommended for use in atrial fibrillation.
The study also identifies an important new anticoagulant safety issue — high rates of rehospitalization for bleeding within 30 days affecting 13.5% of dabigatran patients compared with 5.1% of warfarin patients. After a bleeding event, the warfarin dose can be adjusted downward, a flexibility not available for [Pradaxa (dabigatran)] except for the untested 75-mg dose....
Next, Moore points out another drug safety issue, this one involving the appropriate use of concomitant Pradaxa therapy with antiplatelet agents.
When my colleagues and I analyzed the large [Pradaxa (dabigatran)] trial, we observed that concomitant use of antiplatelet agents, which were used in more than 70% of the bleeding cases in this new study, and we found it doubled the risk of a bleeding event. Regulators and manufacturers also need to reexamine whether [the] safety profile [of Pradaxa (dabigatran)] can be improved with plasma level monitoring, which my previous analysis suggests might lower bleeding rates by 20%.
Given these still-present safety issues when using Pradaxa, we continue to investigate possible drug injury cases against the responsible drug company, Boehringer Ingelheim, for patients who have suffered serious bleeding events.
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