>>CAMBRIDGE, Mass.--(BW HealthWire)--Jan. 30, 2002-- The Medicines Company (NASDAQ: MDCO - news) announced today that a major meta-analysis published by Dr. Yusuf et al. in the journal Lancet has found that direct thrombin inhibitors such as ANGIOMAX® (bivalirudin) are associated with a significantly reduced risk of death or myocardial infarction over the indirect thrombin inhibitor heparin (p=0.001, differences persisting at seven and 30 days). Additionally, the analysis concluded that of the direct thrombin inhibitors, only ANGIOMAX was associated with both a reduction in ischemic events and a reduced risk of major bleeding.
This overview, which was prospectively limited to randomized ACS and PCI trials involving a minimum of 200 patients, compared the outcomes of 11 trials studying six agents in 35,970 patients. In addition to looking at differences between direct thrombin inhibitors (hirudin, bivalirudin, argatroban, efegatran, and inogatran) and the indirect thrombin inhibitor heparin, the study evaluated the differences between bivalent direct thrombin inhibitors (hirudin and bivalirudin) and univalent inhibitors (argatroban, efegatran, and inogatran).
The paper stated, ``At the end of treatment, both hirudin and bivalirudin were associated with lower rates of myocardial infarction than was heparin, but the univalent inhibitors appeared to be associated with an increased risk of myocardial infarction.'' The authors went on to state, ``There seem to be important differences in the risk of major bleeding among individual direct thrombin inhibitors. Hirudin is associated with an increased risk of major bleeding, particularly in acute coronary syndromes without ST elevation, for which there was an almost two-fold excess in major bleeding. By contrast, bivalirudin was associated with a 50% reduction in bleeding risk, mainly in patients undergoing percutaneous coronary intervention, but also evident in those with ST-elevation acute coronary syndromes.''
``This ground-breaking paper spells out the unique profile of Angiomax as an effective foundation intravenous anticoagulant,'' said Clive Meanwell, M.D., Ph.D., Executive Chairman of The Medicines Company. ``The clear advantage of direct thrombin inhibitors over heparin is demonstrated with enormous statistical power and must now be regarded as scientifically robust. Even more exciting for us is the authors' recognition that ANGIOMAX is unique among direct thrombin inhibitors - leading to reductions in both thrombotic and bleeding complications compared to heparin.''
Dave Stack, President and Chief Executive Officer of The Medicines Company added, ``We are impressed with these data which strongly support our market positioning for ANGIOMAX as a replacement for heparin. We have known for some time that ANGIOMAX could be clearly differentiated from its key competitors and this paper clearly underscores our confidence in the brand's future.''<<
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Cheers, Tuck |
