title: Assessment of drug-induced increases in blood pressure during drug development: report from the Cardiac Safety Research Consortium.
abstract: This White Paper, prepared by members of the Cardiac Safety Research Consortium, discusses several important issues regarding the evaluation of blood pressure (BP) responses to drugs being developed for indications not of a direct cardiovascular (CV) nature. A wide range of drugs are associated with off-target BP increases, and both scientific attention and regulatory attention to this topic are increasing. The article provides a detailed summary of scientific discussions at a Cardiac Safety Research Consortium-sponsored Think Tank held on July 18, 2012, with the intention of moving toward consensus on how to most informatively collect and analyze BP data throughout clinical drug development to prospectively identify unacceptable CV risk and evaluate the benefit-risk relationship. The overall focus in on non-CV drugs, although many of the points also pertain to CV drugs. Brief consideration of how clinical assessment can be informed by nonclinical investigation is also outlined. These discussions present current thinking and suggestions for furthering our knowledge and understanding of off-target drug-induced BP increases and do not represent regulatory guidance.
authors.affiliation: Cardiac Safety Research Consortium, Sager Expert Consulting, San Francisco, CA, USA.
authors.forename: Philip
authors.initials: P
authors.lastname: Sager
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Heilbraun
authors.forename: J Rick
authors.initials: JR
authors.lastname: Turner
authors.forename: Gary
authors.initials: G
authors.lastname: Gintant
authors.forename: Mary J
authors.initials: MJ
authors.lastname: Geiger
authors.forename: Peter R
authors.initials: PR
authors.lastname: Kowey
authors.forename: George A
authors.initials: GA
authors.lastname: Mansoor
authors.forename: Boaz
authors.initials: B
authors.lastname: Mendzelevski
authors.forename: Eric L
authors.initials: EL
authors.lastname: Michelson
authors.forename: Norman
authors.initials: N
authors.lastname: Stockbridge
authors.forename: Michael A
authors.initials: MA
authors.lastname: Weber
authors.forename: William B
authors.initials: WB
authors.lastname: White
mesh_terms: D001794:Blood Pressure / Q000187:drug effects*; D018660:Blood Pressure Monitoring, Ambulatory; D002318:Cardiovascular Diseases / Q000139:chemically induced; D002986:Clinical Trials as Topic; D055808:Drug Discovery; D004353:Drug Evaluation, Preclinical; D006801:Humans; D061214:Patient Safety; D018570:Risk Assessment