title: Cardiovascular function in nonclinical drug safety assessment: current issues and opportunities.
abstract: There are several recent examples where clinically significant, safety-related, drug effects on hemodynamics or cardiac function were not apparent until large clinical trials were completed or the drugs entered the consumer market. Such late-stage safety issues can have significant impact on patient health and consumer confidence, as well as ramifications for the regulatory, pharmaceutical, and financial communities. This manuscript provides recommendations that evolved from a 2009 HESI workshop on the need for improved translation of nonclinical cardiovascular effects to the clinical arena. The authors conclude that expanded and improved efforts to perform sensitive yet specific evaluations of functional cardiovascular parameters in nonclinical studies will allow pharmaceutical companies to identify suspect drugs early in the discovery and development process while allowing promising drugs to proceed into clinical development.
authors.affiliation: Data Sciences International, St. Paul, MN, USA.
authors.forename: R Dustan
authors.initials: RD
authors.lastname: Sarazan
authors.forename: Scott
authors.initials: S
authors.lastname: Mittelstadt
authors.forename: Brian
authors.initials: B
authors.lastname: Guth
authors.forename: John
authors.initials: J
authors.lastname: Koerner
authors.forename: Joanne
authors.initials: J
authors.lastname: Zhang
authors.forename: Syril
authors.initials: S
authors.lastname: Pettit
mesh_terms: D002320:Cardiovascular Physiological Phenomena; D064420:Drug-Related Side Effects and Adverse Reactions; D006321:Heart / Q000187:drug effects*; D006439:Hemodynamics / Q000187:drug effects*; D006801:Humans