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Data show drug being tested to reduce cardiovascular events increased risk of heart attack
Date:11/18/2013

Monday, Nov. 18, 2013, Cleveland: Patients with acute coronary syndrome who were treated with the experimental drug varespladib were more likely to experience additional cardiovascular events including sudden death, heart attack and stroke than those treated with placebo, according to research from the Cleveland Clinic Coordinating Center for Clinical Research (C5Research).

The results of the VISTA-16 (Vascular Inflammation Suppression to Treat Acute Coronary Syndrome for 16 Weeks) trial, which was halted last year for futility and possible harm, were presented today at the American Heart Association Scientific Sessions 2013 in Dallas and published simultaneously in the Journal of the American Medical Association (JAMA).

Varespladib inhibits production of the compound secretory phospholipase A2 (sPLA2), which promotes the vascular inflammation implicated in the development of atherosclerosis, or the clogging and hardening of arteries.VISTA-16 was designed to test whether the use of varespladib to reduce sPLA2 would lower the risk of cardiovascular events in patients with acute coronary syndrome. Patients with acute coronary syndrome have had a heart attack or experienced unstable angina, which can lead to a heart attack.

Rather than reduce additional cardiovascular events, including sudden death, heart attack, stroke, and unstable angina, the study found that patients treated with varespladib were more likely than those treated with placebo to experience these events. Both groups of patients were also treated with statin therapy and standard-of-care protocols. The primary endpoint, a composite of sudden death, heart attack, stroke and unstable angina, occurred in 6.1 percent of patients on varespladib compared to 5.1 percent of those on placebo.

In addition, the study found that varespladib was associated with a significantly greater risk of heart attack, occurring in 3.4 percent of the study populatio
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Contact: Wyatt DuBois
duboisw@ccf.org
216-445-9946
Cleveland Clinic
Source:Eurekalert

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