Integrated cardiovascular safety: multifaceted considerations in drug development and therapeutic use

Cardiovascular safety has become a central component of contemporary drug development and therapeutic use since noncardiovascular drugs can exert cardiovascular harms. Appropriate preapproval investigations and monitoring during clinical practice are therefore advantageous. Areas covered: Integrated cardiovascular safety is a broad field of investigation. This review focuses on three areas of assessment specifically chosen to exemplify advances and challenges in this field: the cardiotoxicity of oncologic agents, off-target blood pressure (BP) increases to noncardiovascular drugs, and the cardiovascular safety of new antidiabetic drugs for type 2 diabetes (T2D). Expert opinion: Good progress has been made in the field of Cardio-oncology in the last decade, and endeavors to include discipline-specific training in medical curricula are particularly encouraging. Less formalized progress has been made with regard to addressing off-target BP increases. In the third domain discussed, recent developments suggest that the focus of attention may shift from cardiovascular safety to cardiovascular benefit in light of a recent decision by the US FDA: in December 2016 it approved a new indication for empagliflozin to reduce the risk of cardiovascular death in adult patients with T2D and established cardiovascular disease.