Varespladib Linked to Increased Risk of Cardiovascular Events
Clinical trial results for Anthera Pharmaceuticals’ experimental drug varespladib presented Tuesday at the American Heart Association Scientific Sessions 2013 show that patients treated with the drug experienced an increased risk of suffering major cardiovascular events including heart attack, stroke and sudden death.
Varespladib and the VISTA-16 Clinical Trial
According to News Medical, varespladib is an experimental drug which was being developed by Anthera Pharmaceuticals as a possible treatment for several inflammatory diseases, including acute coronary syndrome and acute chest syndrome.
During the VISTA-16 clinical trial, researchers with the Cleveland Clinical Coordinating Center for Clinical Research (C5Research) were testing the drug as a treatment to reduce the risk of cardiovascular events in patients who have previous had a heart attack or experienced unstable angina.
However, rather than reduce the risk of cardiovascular events, researchers found that patients treated with varespladib were more likely to suffer stroke, heart attack or sudden death than those receiving a placebo, leading to the Data and Safety Monitoring Board halting the trials in March 2012.
VISTA-16 Trial Results Released
“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 published by News Medical
More than a year after being halted for futility and possible harm, the results for the VISTA-16 clinical trial have been released to the public.
On Tuesday, the complete VISTA-16 data was presented at the American Heart Association Scientific Sessions 2013 in Dallas, Texas and simultaneously published in the Journal of the American Medical Association.
According to the research:
- VISTA-16 trial enrolled 5,000 patients across North America, Europe, New Zealand, India and Australia
- Sudden death, heart attack, stroke and unstable angina occurred in 6.1 percent of patients being treated with varespladib compared to 5.1 percent in patients receiving a placebo.
- 3.4 percent of patients treated with varespladib suffered from heart attack compared to a rate of 2.2 percent among the placebo group, meaning that varespladib effectively boosted heart attack risks by 65 percent.
VISTA-16 Clinical Trial Locations
- Mission Viejo
- Colorado Springs
- Fort Collins
- Wheat Ridge
District of Columbia
- Ft. Lauderdale
- Miami Beach
- Oak Lawn
- New Orleans
- Traverse City
- Johnson City
- North Dakota
- Oklahoma City
- Rapid City
- Sioux Falls
Contact an Experienced Clinical Trial Attorney
Thomas J. Henry are leaders in the area clinical trial litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. Our Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.
If you or a loved one have been injured by or have developed serious side-effects while participating in a clinical trial, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.