Drug doesn’t prevent recurrent cardiovascular events, linked to greater heart attack risk
American Heart Association Late-Breaking Clinical Trial Report LBCT 4/Abstract: 19610 (Ballrooms C1 & C2)
- An experimental drug doesn’t prevent cardiovascular events from recurring in patients with blocked blood vessels to the heart.
- Compared to placebo, varespladib was also associated with an increased risk of heart attacks.
DALLAS, Nov. 18, 2013 — An experimental drug doesn’t prevent cardiovascular events from recurring and is linked to increased heart attack risk in patients with blocked blood vessels to the heart, according to a late-breaking clinical trial presented at the American Heart Association’s Scientific Sessions 2013.
These findings led to the early conclusion of VISTA-16, a large clinical trial examining whether the drug, varespladib, a secretory phospholipase A2 inhibitor, could prevent future events among patients hospitalized with symptoms of a sudden decrease in blood flow to the heart.
Researchers studied more than 5,000 patients, 40 years and older with symptoms of decreased blood flow to the heart at 362 sites in 17 countries in May 2010-March 2012. They randomly assigned patients to receive 500 milligrams of varespladib or placebo daily for 16 weeks.
All patients also received established medications for treating blocked blood vessels to the heart. Treatment began within 96 hours of patients’ arrival at the hospital with symptoms.
At the study’s early termination in March 2012, 6.1 percent of patients in the varespladib group had recurrent events including heart attacks, other heart complication, or death, as compared to 5.1 percent among the placebo group.
Patients who received varespladib were significantly more likely to have a recurrent heart attack (3.4 percent) than those who received placebo (2.2 percent).
“Varespladib was not associated with improvement of severe heart disease and resulted in a greater rate of heart attacks,” said Stephen Nicholls, M.D., Ph.D., the study’s lead author and deputy director of the South Australian Health and Medical Research Institute.
Previous laboratory studies had revealed that varespladib inhibits tissue inflammation — possibly preventing heart events related to a decrease in blood and oxygen flow to the heart.
“That theory didn’t play out in our study,” said Nicholls, professor of cardiology at the University of Adelaide and consultant cardiologist at the Royal Adelaide Hospital in Australia. “In fact, our results suggest the drug could be more harmful for these patients.”
Co-authors are J.J. Kastelein, M.D., Ph.D.; Danielle Brennan, M.S. and Gregory G. Schwartz, Ph.D.
Anthera Pharmaceuticals funded the study. Disclosures
For more news from AHA Scientific Sessions 2013, follow @HeartNews #AHA13 on Twitter.
Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and device corporations are available at www.heart.org/corporatefunding.
Note: Actual presentation is 4:07 p.m. CT/5:07 p.m. ET, Monday, Nov. 18, 2013, in Ballrooms C1 & C2.
AHA News Media in Dallas: (214) 706-1173