Markers of Vascular Damage and Repair

Erdbruegger, Uta; Dhaygude, Ajay; Woywodt, Alexander

doi:10.5772/19786

Cited by 1 publication

(2 citation statements)

References 97 publications

(72 reference statements)

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“…In addition to more conventional analytes such as soluble proteins or cytokines noted in the previous references, other less routine sources of vascular biomarkers are being developed that hold promise in the large molecule arena, including endothelial cell microparticles (EMP; Enerson et al 2010, Erdbruegger et al 2008). EMP can serve as surrogate markers of endothelial function and elevated levels of EMP have been seen in patients with vascular diseases, and may correspond to vascular injury in patients with cardiovascular disease and/or vasculitis (Ardoin, Shanahan, and Pisetsky 2007; Brogan et al 2004; Clarke et al 2010; Dignat-George and Boulanger 2011; Erdbruegger et al 2008, Erdbruegger, Dhaygude, and Woywodt 2011; Mesri and Altieri 1998; 1999). Circulating endothelial cells (CEC) have also been proposed as biomarkers of DIVI (Thomas et al 2009) and are thought to be detached following injury and hence detectable in the peripheral circulation.…”

Section: Differentiation From Spontaneous Vascular Disease In Laboratory Animalsmentioning

confidence: 99%

“…EMP can serve as surrogate markers of endothelial function and elevated levels of EMP have been seen in patients with vascular diseases, and may correspond to vascular injury in patients with cardiovascular disease and/ or vasculitis (Ardoin, Shanahan, and Pisetsky 2007;Brogan et al 2004;Clarke et al 2010;Dignat-George and Boulanger 2011;Erdbruegger et al 2008, Erdbruegger, Dhaygude, andWoywodt 2011;Mesri and Altieri 1998;. Circulating endothelial cells (CEC) have also been proposed as biomarkers of DIVI (Thomas et al 2009) and are thought to be detached following injury and hence detectable in the peripheral circulation.…”

Section: Biomarkers Of Biotherapeutic-associated Divimentioning

confidence: 99%

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Scientific and Regulatory Policy Committee Points-to-consider Paper*

Frazier

Engelhardt

Fant³

et al. 2015

Toxicol Pathol

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Drug-induced vascular injury (DIVI) is a recurrent challenge in the development of novel pharmaceutical agents. Although DIVI in laboratory animal species has been well characterized for vasoactive small molecules, there is little available information regarding DIVI associated with biotherapeutics such as peptides/proteins or antibodies. Because of the uncertainty about whether DIVI in preclinical studies is predictive of effects in humans and the lack of robust biomarkers of DIVI, preclinical DIVI findings can cause considerable delays in or even halt development of promising new drugs. This review discusses standard terminology, characteristics, and mechanisms of DIVI associated with biotherapeutics. Guidance and points to consider for the toxicologist and pathologist facing preclinical cases of biotherapeutic-related DIVI are outlined, and examples of regulatory feedback for each of the mechanistic types of DIVI are included to provide insight into risk assessment.

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