Drugmaker AstraZeneca has terminated a major Phase III clinical trial into the efficacy of the fish oil-derived drug Epanova. Previously, the U.S. Food and Drug Administration (FDA) approved its use in patients with high triglycerides. The new trial aims to identify a wide range of users of the drug as an adjunct to conventional heart disease drugs (statins).
(From: AstraZeneca, via New Atlas)
In recent years, several studies have claimed that omega-3 fish oil supplements may have special complementary effects, such as reducing the risk of cardiovascular disease and stroke.
However, a large 2018 study found no evidence that supplementing omega-3 prevents coronary heart disease or reduces the protective effect of all-cause mortality.
Several manufacturers have been trying to prove that certain fatty acids found in fish oil can be purified, concentrated and made into targeted drugs.
After the advisory group recommended it as an complementary treatment for conventional statin therapy, the FDA approved the use of a drug called Vascepa in a broader cardiovascular treatment in December 2019.
As a purification of a specific fatty acid found in fish oil, Vascepa, also known as EPA, is a combination of EPA and another omega-3 fatty acid (22 carbon hexaene/ DHA).
Both previous drugs have been approved by the FDA to treat patients with high triglyceride levels. The competition has been going on for several years to complete larger clinical trials in the hope that the drug will be widely used and thus officially used in the treatment of heart disease.
Epanova’s large-scale Phase III trial failed after an independent data monitoring committee assessed data on more than 13,000 patients. Complete trial data, expected to be presented at future medical conferences.
The trial, called STRENGTH, spans 22 countries and is being studied in the study of The efficacy of Epanova compared to placebos, such as reducing the risk of adverse events in the treatment of major cardiovascular diseases.
“The academic leaders of the STRENGTH trial are disappointed with this result, but we are honored to have the opportunity to answer this important scientific question as a model of collaboration between academic physicians and the industry,” said Steven Nissen, head of research.