Maybe Pradaxa (dabigatran) does need blood monitoring after all

2.5 out of 5 stars The Effect of Dabigatran Plasma Concentrations and Patient Characteristics on the Frequency of Ischemic Stroke and Major Bleeding in Atrial Fibrillation Patients. Reilly PA et al. J Am Coll Cardiol 2014 Feb 4;63:321-8. Abstract A must-read article in yesterday’s New York Times described the internal battle at Boehringer Ingelheim, the maker of Pradaxa (dabiagtran etexilate), concerning the publication of this study. A major marketing point posited in favor of dabigatran over warfarin for the prevention of stroke in patients with atrial fibrillation was that it did not require monitoring with regular blood tests. However, a number of observers, including TPR, have pointed out that dabigatran has a both a complex pharmacokinetic profile  and concentration-dependent effects ( beneficial and adverse). Therefore, monitoring blood levels may indeed be necessary for optimal therapeutic use of the drug. This paper — written by researchers at Boehringer Ingelheim — analyzed data from the original RE-LY study to determine the effect of serum dabigatran concentration on the benefit (prevention of ischemic strokes) and risk (occurrence of major bleeding) of treatment with the drug. According to the Times article — which was based on internal Boehringer documents released in association with ongoing lawsuits again the drug manufacture — the original draft of the paper specified blood levels that would maximize benefit and minimize risk of treatment....
Source: The Poison Review - Category: Toxicology Authors: Tags: Medical bleeding blood testing boehringer ingelheim dabigatran pradaxa stroke Source Type: news