The best magazine
Introduction
An intricate balance exists between the safety and efficacy of antithrombotic therapies in acute coronary syndrome (ACS). Safety is largely defined by bleeding risks. Many bleeding definitions are used in clinical trials, and conclusions may differ depending on the definition applied. Bleeding risks are typically dose related, making selection of the optimal dose (or preferably, doses) to advance from phase II to III testing a critical step in drug development.
Efficacy is defined in terms of thrombotic event reduction and is commonly assessed using composite endpoints. However, composite endpoints create interpretive challenges within and across trials, particularly when endpoint definitions vary substantially. The trade-off between benefits (reduction in thrombotic events) and risks (increase in bleeding) is important to patients and clinicians; thus, it is imperative that data are presented clearly to facilitate informed decision making. Antithrombotic drug development for ACS is a challenging area of cardiovascular medicine, a topic discussed during the 7th and 8th Global Cardiovascular Clinical Trialists (CVCT) forums in December 2010 and 2011. This manuscript highlights key points from those discussions.
Source: ...