Author Interviews, Lancet / 19.06.2015

MedicalResearch.com Interview with: Dr. Stephan Glund Ph.D. Boehringer Ingelheim Pharma GmbH & Co. KG Transl. Medicine & Clin. Pharmacology Medical Research: What is the background for this study? What are the main findings? Dr. Glund: There are currently no specific reversal agents available for any of the non-Vitamin K antagonist oral anticoagulants (NOACs). We are working on the development of idarucizumab, a specific reversal agent to dabigatran, the first approved NOAC. The study now published in The Lancet investigated, for the first time in healthy volunteers, the reversal of the anticoagulant effect of dabigatran by idarucizumab. Our study in healthy male volunteers showed that idarucizumab led to immediate, complete and sustained reversal of the anticoagulant effect of dabigatran. Participants first received dabigatran and then idarucizumab. The specific reversal agent was given two hours after the last dose of dabigatran, when dabigatran concentrations were at peak levels. After a five-minute infusion of idarucizumab, anticoagulation was immediately reversed back to baseline levels. The reversal effect was sustained for more than 24 hours for all doses of 2g and above. Idarucizumab was well tolerated by the study participants. In addition, our study also showed that administration of idarucizumab reversed dabigatran-induced inhibition of wound-site fibrin formation, which plays a key role in the blood clotting mechanism. This suggests that idarucizumab might also reverse impaired haemostasis due to dabigatran anticoagulation at a wound site. (more…)
Author Interviews, Heart Disease, NEJM / 01.09.2014

Gilles Montalescot M.D., Ph.D. Professor of Cardiology University of Paris VI; Director, Cardiac Care Unit Institute of Cardiology, Pitié-Salpêtrière University Hospital Paris, FranceMedicalResearch.com Interview with: Gilles Montalescot M.D., Ph.D. Professor of Cardiology University of Paris VI; Director, Cardiac Care Unit Institute of Cardiology, Pitié-Salpêtrière University Hospital Paris, France Medical Research: What are the main findings of the study? Dr. Montalescot : Among the 1862 patients with ongoing STEMI who were enrolled in the ATLANTIC study, we found no difference between those randomized to pre-hospital (in-ambulance) ticagrelor 180 mg and those randomized to in-hospital (in-catheterization laboratory) ticagrelor 180 mg in terms of either pre-PCI ST-segment elevation resolution (≥70%) or pre-PCI TIMI 3 flow in the culprit artery, which were the co-primary endpoints. There was also no difference between the groups in terms of major adverse cardiovascular events at 30 days, with the exception that rates of definite stent thrombosis were lower in the pre-hospital ticagrelor group than in the in-hospital group, both in the first 24 hours (0% versus 0.8%, p= 0.008) and at 30 days (0.2% versus 1.2%, p = 0.02). The safety of pre-hospital ticagrelor did not appear to be an issue, since the incidence of non-CABG-related major bleeding was low and similar in both treatment groups, whichever bleeding definition was used (PLATO, TIMI, STEEPLE, GUSTO, ISTH or BARC). (more…)