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Anthera Varespladib Trials

Heart Attack, Stroke, and Death in Anthera Varespladib Trials

“Despite prior experimental and observational data suggesting that varespladib would have beneficial cardiovascular effects, this trial proves the contrary, that it is actually detrimental to cardiovascular morbidity and mortality.” – VISTA-16 executive committee chair Stephen J. Nicholls, MD, PhD, as reported in News Medical.

Thomas J. Henry is currently investigating reports of heart attack, stroke, and sudden death linked to Anthera Pharmaceuticals’ experimental cardiovascular drug varespladib.


Anthera Pharmaceuticals was originally developing varespladib as a treatment to reduce the risk of cardiovascular events in patients with acute coronary syndrome (ACS); however, clinical trial data soon showed that the drug was having the opposite effect.

The clinical trial, labeled VISTA-16 by C5Research, was halted by the Data Safety Monitoring Board in March 2012 after noting no improvement in ACS patients treated with varespladib. Later analysis of trial data revealed that treatment with varespladib was associated with an increased risk of heart attack, stroke, and sudden death.


  • The research collected by C5Research during the VISTA-16 trial was not released until more than a year after the study was halted.
  • On November 19, 2013, the VISTA-16 trial data was presented during the American Heart Association Scientific Session 2013 – the same day the trial results were published in the Journal of the American Medical Association (JAMA).
  • According to composite data, unstable angina, stroke, heart attack, and sudden death occurred in 6.1% of patients treated with varespladib compared to a rate of 5.1% among the placebo group.
  • Patients treated with varespladib were 65% more likely to suffer heart attack than those receiving a placebo (3.4% for the varespladib group, 2.2% for placebo group).


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