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Incorporating biomarkers into clinical trials in cardiovascular medicine

Authors Lee H, Ota S

Received 15 April 2014

Accepted for publication 4 June 2014

Published 4 September 2014 Volume 2014:4 Pages 121—132


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Hsiu-Fang Lee, Sho Ota

Trialynx, Inc., Ann Arbor, MI, USA

Abstract: Developing novel therapies and establishing clinical benefits over conventional therapies has become a highly competitive and a costly endeavor. In this regard, biomarkers have become increasingly important in accurately assessing both efficacy and safety of these novel therapies. While the use of biomarkers has proved vital in cardiovascular research and disease management, current established biomarkers are inadequate in capturing and accounting for the entire cardiovascular disease process and responses to therapeutic interventions. Substantial effort has been made in exploring and clinically evaluating novel biomarkers. The present review aims to shed light on some of the novel cardiovascular biomarkers being investigated, including high sensitivity C-reactive protein, proprotein convertase subtilisin/kexin type 9, P-selectin, secretory phospholipase A2, lipoprotein-associated phospholipase A2, and growth differentiation factor 15, and illustrate their relevance to clinical research.

Keywords: hs-CRP, PCSK9, P-selectin, sPLA2, Lp-PLA2, GDF-15

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