title: Clinical imaging in anti-atherosclerosis drug development.
abstract: The development of novel drugs for the treatment of atherosclerosis faces many challenges, particularly caused by the need for large and costly outcome trials. When predictive biochemical biomarkers are not available, clinical imaging data can serve as intermediate Phase II endpoints to demonstrate mechanistic and anti-atherosclerotic activity of new compounds. These data can support risk mitigation before continuing development in large Phase III outcome trials. Imaging techniques such as magnetic resonance imaging (MRI), computed tomography (CT) and ultrasound [intima-media thickness (IMT) and intravascular ultrasound (IVUS)] can provide detailed information on vascular plaque volume and morphology, whereas functional changes can potentially be captured by positron emission tomography (PET) techniques in the vessel wall. We will review the application and operational aspects of clinical imaging methods and endpoints used in interventional atherosclerosis trials.
authors.affiliation: Department of Translational Medicine & Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorferstrasse 65, 88397 Biberach, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Ehlgen
authors.affiliation: Therapeutic Area Cardiovascular Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216 Ingelheim, Germany.
authors.forename: Anders
authors.initials: A
authors.lastname: Bylock
authors.affiliation: Therapeutic Area Cardiovascular Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG, Binger Straße 173, 55216 Ingelheim, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Kreuzer
authors.affiliation: Department of Translational Medicine & Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorferstrasse 65, 88397 Biberach, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Koslowski
authors.affiliation: Department of Translational Medicine & Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorferstrasse 65, 88397 Biberach, Germany.
authors.forename: Florian
authors.initials: F
authors.lastname: Gantner
authors.affiliation: Department of Translational Medicine & Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorferstrasse 65, 88397 Biberach, Germany. Electronic address: heiko.niessen@boehringer-ingelheim.com.
authors.forename: Heiko G
authors.initials: HG
authors.lastname: Niessen
mesh_terms: D050197:Atherosclerosis / Q000175:diagnosis / Q000188:drug therapy* / Q000473:pathology; D002986:Clinical Trials as Topic / Q000379:methods; D003952:Diagnostic Imaging / Q000379:methods*; D015195:Drug Design; D023381:Endpoint Determination; D006801:Humans; D058226:Plaque, Atherosclerotic / Q000188:drug therapy / Q000473:pathology; D049268:Positron-Emission Tomography / Q000379:methods