Novel molecules and diagnostic tests

Implications: Diagnostic tools are availible to identify these adverse effects at an early stage in their clinical development. These tools should mitigate the seriousness of these adverse events.

Analysis: Myocardial damage represents a serious side-effect for any therapeutic agent, but there are laboratory tools to assess this during clinical trials, during the marketing phase of the molecule (Phase IV) and during clinical treatment. While cardiac tropoinin (I or T) are not specific for the placque rupture and/or placque formation associated with acute myocardial infarction, it is a very sensitive marker of myocardial damage and death (v. Waxman, Schappert, Husk. 2007) and should be utilized in these situations. Also while there are issues utilizing BNP to accurately classify CHF, monitoring patients with BNP can provide early and accurate information regarding deterioration of cardiac output and the development in its early stages of CHF. Utilisation of these two diagnostic markers to monitor patients in clinical trials or during their clinical use  should identify patients who are experiencing adverse cardiac effects, and permit early and effective management.