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VISTA-16 study halted early
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An independent data and safety monitoring board has recommended that the VISTA-16 clinical study, which is investigating the effects of varespladib in patients with acute coronary syndromes, be stopped because of a lack of efficacy that could not be reasonably overcome in the remainder of the trial, according to an announcement by Anthera Pharmaceuticals.
The randomized, double blind, placebo-controlled VISTA-16 study was conducted to determine whether 16 weeks of treatment with varespladib (A-002) 500 mg once daily plus atorvastatin and standard of care is superior to placebo plus atorvastatin and standard of care for reducing CV morbidity and mortality. The study was designed to enroll up to 6,500 patients with ACS. The study started in May 2010.
Now, Anthera Pharmaceuticals has closed enrollment of the phase 3 clinical study and informed all investigators to remove patients from therapy immediately. The data and safety monitoring board’s (DSMB) recommendation was based on a review of the totality of the safety and efficacy data available for the VISTA-16 study.
“Based on all the evidence we have seen regarding varespladib and secretory phospholipase and in light of previous study results, we were surprised by the recommendation from the DSMB,” Stephen Nicholls, MD, CVD director of the Cleveland Clinic Coordinating Center for Clinical Research and chairman of the executive committee overseeing the VISTA-16 trial, said in a press release. “We believed that the study was coming along as expected, and this new information was totally unexpected and disappointing given the potential benefits of this drug.”
Varespladib is a secretory phospholipase A2 enzyme inhibitor. Previous studies have demonstrated that the drug may reduce biomarkers and effects on surrogate CV endpoints.