Cleveland Clinic Coordinating Center for Clinical Research, Cleveland Clinic, Cleveland, OH 44195, USA.
Cardiovasc Drugs Ther. 2012 Feb;26(1):71-5. doi: 10.1007/s10557-011-6358-9.
The action of secretory phospholipase A(2) (sPLA(2)) on lipoproteins may render them more susceptible to oxidation, thereby promoting vascular inflammation and increasing cardiovascular risk. Patients with acute coronary syndrome face a high risk of early, recurrent cardiovascular events that is associated with biomarkers of inflammation, including sPLA(2). The Vascular Inflammation Suppression to Treat Acute Coronary Syndrome for 16 Weeks (VISTA-16, NCT01130246) tests the hypothesis that varespladib methyl, an inhibitor of several sPLA(2) isoforms with a causal role in atherosclerosis, reduces cardiovascular risk among patients with acute coronary syndromes.
Up to 6,500 patients with acute coronary syndrome will be randomized to receive treatment with varespladib methyl 500 mg daily or placebo for 16 weeks, in addition to background treatment with atorvastatin and other evidence-based therapies. The primary efficacy parameter is the combination of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or hospitalization for unstable angina with objective evidence of myocardial ischemia. Effects of varespladib methyl on lipid and inflammatory markers, in addition to safety and tolerability, will also be evaluated.
sPLA(2) inhibition has the potential to exert a favorable effect on the artery wall. The VISTA-16 study will determine whether varespladib methyl has a beneficial impact on cardiovascular events in patients with an acute coronary syndrome.
分泌型磷脂酶 A2（sPLA2）对脂蛋白的作用可能使它们更容易氧化，从而促进血管炎症并增加心血管风险。急性冠脉综合征患者面临早期复发心血管事件的高风险，这与炎症的生物标志物有关，包括 sPLA2。血管炎症抑制治疗急性冠脉综合征 16 周（VISTA-16，NCT01130246）检验了这样一个假设，即抑制几种 sPLA2 同工型的抑制剂瓦瑞司他汀（varespladib methyl）在动脉粥样硬化中具有因果关系，可降低急性冠脉综合征患者的心血管风险。
多达 6500 名急性冠脉综合征患者将被随机分配接受瓦瑞司他汀甲基 500mg 每日治疗或安慰剂治疗 16 周，此外还接受阿托伐他汀和其他循证治疗。主要疗效参数是心血管死亡、非致死性心肌梗死、非致死性卒中和不稳定型心绞痛伴心肌缺血客观证据的住院治疗的组合。还将评估瓦瑞司他汀甲基对血脂和炎症标志物的影响，以及安全性和耐受性。
sPLA2 抑制有可能对动脉壁产生有利影响。VISTA-16 研究将确定瓦瑞司他汀甲基是否对急性冠脉综合征患者的心血管事件产生有益影响。
