title: Integrated cardiovascular safety: multifaceted considerations in drug development and therapeutic use.
abstract: 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.
authors.affiliation: a Cardiac Safety Services, QuintilesIMS , Durham , NC , USA.|b Department of Pharmacy Practice , Campbell University College of Pharmacy & Health Sciences , Buies Creek , NC , USA.
authors.forename: J Rick
authors.initials: JR
authors.lastname: Turner
mesh_terms: D000328:Adult; D000818:Animals; D000970:Antineoplastic Agents / Q000009:adverse effects; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects; D066126:Cardiotoxicity / Q000209:etiology* / Q000517:prevention & control; D002318:Cardiovascular Diseases / Q000139:chemically induced* / Q000517:prevention & control; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D015195:Drug Design; D005960:Glucosides / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D001559:Benzhydryl Compounds; D005960:Glucosides; D007004:Hypoglycemic Agents; C570240:empagliflozin
keywords: Cardiovascular safety education; cardio-oncology; co-prescription of antihypertensive agents; empagliflozin; off-target blood pressure increases