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

Abstract	Secretory 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.
Authors	Robert S Rosenson
Journal	Future cardiology (Future Cardiol) Vol. 7 Issue 1 Pg. 11-8 (Jan 2011) ISSN: 1744-8298 [Electronic] England
PMID	21174506 (Publication Type: Clinical Trial, Phase II, Journal Article)
Chemical References	Acetates Anticholesteremic Agents Biomarkers Cholesterol, LDL Heptanoic Acids Indoles Keto Acids Pyrroles varespladib C-Reactive Protein Atorvastatin Phospholipases A2, Secretory
Topics	Acetates (therapeutic use) Acute Coronary Syndrome (drug therapy, physiopathology) Analysis of Variance Anticholesteremic Agents (therapeutic use) Atorvastatin Biomarkers (blood) C-Reactive Protein (drug effects) Cholesterol, LDL (drug effects) Endothelium, Vascular (drug effects) Female Heptanoic Acids (therapeutic use) Humans Hyperlipidemias (drug therapy, physiopathology) Indoles (therapeutic use) Keto Acids Logistic Models Male Middle Aged Phospholipases A2, Secretory (antagonists & inhibitors) Pyrroles (therapeutic use)

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