• Future cardiology · Jan 2011

    After FRANCIS: next steps in the clinical evaluation of varespladib methyl.

    • Robert S Rosenson.
    • Mount Sinai School of Medicine, New York, NY 10029, USA. robert.rosenson@mssm.edu
    • Future Cardiol. 2011 Jan 1; 7 (1): 11-8.

    AbstractSecretory phospholipase A(2) (sPLA(2)) represents a family of isoenzymes that participate in lipoprotein and inflammatory pathways, mediate atherosclerosis and enhance myocardial ischemic injury. The Fewer Recurrent Acute Coronary Events with Near-term Cardiovascular Inflammatory Suppression (FRANCIS) trial (NCT00743925) was a Phase II trial designed to examine the effects of varespladib methyl, a small-molecule inhibitor of sPLA(2), on plasma biomarkers in patients with acute coronary syndrome (ACS) who were treated with atorvastatin 80 mg and standard-of-care daily. Varespladib methyl significantly reduced low-density lipoprotein cholesterol and inflammatory biomarkers in ACS subjects treated with standard-of-care and atorvastatin 80 mg daily. There was a nonsignificant reduction in major adverse cardiovascular events at study completion; however, positive trends remained for unstable angina and myocardial infarction. In order to achieve the widespread use of varespladib methyl in ACS patients, completion of a prospective, randomized placebo-controlled trial in ACS patients and stable coronary artery disease patients with increased sPLA(2) activity will be required.

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