WikiDoc state of the art review on bivalirudin
Overview
Bivalirudin (Angiomax™) is a drug that belongs to the anticoagulant class and acts as a direct thrombin inhibitor.
Comparative Results
In a large comparative 30-days study encompassing 6,010 patients (called REPLACE2 study) Bivalirudin was compared with a standard therapy of either Abciximab or Eptifibatide plus initial Heparin bolus. The study had a randomized, double-blinded design. Regarding the primary endpoint (death, myocardial infarction, urgent revascularization procedures, severe bleedings) no statistically significant difference between Bivalirudin and standard therapy was noticed (9.2 versus 10.0 %). Regarding ischemic complications (death, myocardial infarction, and urgent revascularization procedures) there was also no statistically significant difference (7.6 vs. 7.1 %). But the risk for severe bleedings was 2.4 % in the Bivalirudin group compared to 4.1 % in the standard therapy-group; a significant difference. In an additional study comparing historical data of Heparin alone (EPISTENT, ESPRIT) with current Bivalirudin results, Bivalirudin gave superior results. Bivalirudin was licensed based on the results of both the REPLACE2 study and the historical data.
References
- AHFS Database online
- http://www.pharmazeutische-zeitung.de/index.php?id=121&type=0 (in German)
- Arzenimittel-Datenbank (in German)
- http://rx.onconews.org/news/Bivalirudin.html
- http://www.emea.europa.eu/humandocs/PDFs/EPAR/angiox/H-562-PI-de.pdf (Document of the European Drug Agency, in German)