Thomas J. Moore, of the Institute for Safe Medication Practices, recently wrote a “Perspective” piece about new Pradaxa-versus-warfarin study, which is described below.
Medical researchers 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.
In his “Perspective” piece, Moore added 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….
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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