By Steven Reinberg and Ernie Mundell HealthDay Reporters
MONDAY, November 16, 2020 (HealthDay News) – Does high strength fish oil help the heart or not?
Previous research on a prescription fish medicine called Vascepa, announced earlier this year, suggested it could be of real value for heart patients.
However, the results of a study of another such drug called Epanova released on Sunday are disappointing: the researchers found no benefit from taking the drug for a variety of heart health outcomes compared to taking a placebo pill, which only contains corn oil.
“Many people continue to take fish oil supplements to help prevent heart disease [new] The process was not effective for this purpose, “co-researcher Dr. A. Michael Lincoff said in an American Heart Association press release.
He is vice chairman of research in the Cardiovascular Medicine Department at the Cardiovascular and Thoracic Institute at the Cleveland Clinic.
The research was presented at the AHA’s annual virtual meeting on Sunday. At the same time it was also published in the Journal of the American Medical Association.
The new study was funded by AstraZeneca, which makes Epanova. AstraZeneca announced on Friday that the Phase III study would be canceled due to disappointing results.
The conflicting results from studies with the two prescription drugs Vascepa and Epanova create confusion as to whether or not heart patients really benefit from the nutrient.
“The question of whether omega-3s improve health is important for patients, doctors and the healthcare system,” noted Dr. Gregory Curfman, who wrote an editorial on the study. “Even in the COVID-19 era, cardiovascular disease is the leading cause of death in the US.”
“Given the current uncertain state of knowledge, neither patients nor doctors can be certain that omega-3 fatty acids have health benefits,” he said.
That probably won’t stop Americans from buying the supplements: “In 2019, the global omega-3 fatty acid market reached $ 4.1 billion and is expected to double by 2025,” said Curfman.
The new study focused on Epanova, which contains a combination of two omega-3 carboxylic acids – eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA].
More than 13,000 patients treated at centers around the world were given either Epanova or a placebo pill with corn oil. All patients had conditions of “high cardiovascular risk”. For example, they were treated with cholesterol-lowering statins and either had blockages in the coronary arteries or arteries in the brain or legs, or were at risk for heart disease because of conditions such as diabetes or lifestyle risk factors such as smoking.
Registration for the study began in 2014. The study ended in January 2020, Lincoff’s group said.
During this period, over 1,600 patients experienced a cardiac event. However, the use of Epanova did not reduce deaths from heart disease, heart attack, stroke, the need for stents or bypass surgery, or hospitalization for angina.
The treatment even had a downside: the researchers say that using the prescription fish oil has been linked to an increase in the risk of the common abnormal heart rhythm called atrial fibrillation.
But if Epanova doesn’t seem to be of any benefit, why have heart patients given another prescription omega-3 drug, Vascepa, apparently got a health boost?
According to Curfman, the answer could be in the study design.
Vascepa contains a form of purified EPA known as icosapent ethyl. The clinical study that appeared to confirm the effectiveness of Vascepa lasted 5 years. The researchers found that use of the drug was linked to a 25% reduction in a variety of cardiac events compared to placebo – in this case, mineral oil.
“Why did these two high-quality clinical studies, both of which use the same high dose of omega-3 fatty acids, come up with opposite results?” Asked Curfman.
Choosing the placebo – mineral oil or corn oil – could help explain the discrepancy, he said. Perhaps Vascepa “did not reduce the risk of cardiovascular events, but rather the comparator, mineral oil, increased the risk of cardiovascular events,” Curfman theorized. That could create the illusion that Vascepa was helping patients, he argued.
There is some evidence that mineral oil may increase levels of bad LDL cholesterol, Curfman noted.
However, the theory that the choice of placebo affects the results of the Vascepa study has not been tested at this time, he pointed out.
“Only a new clinical trial of ikosapent-ethyl versus corn oil would definitely answer the question, but it is unlikely to be done by the private industry,” said Curfman.
Therefore, he added, “The FDA should require a clinical study after the marketing of high-dose icosapent ethyl versus corn oil in patients at risk for cardiovascular events.”
You can learn more about the benefits of fish oil supplements at the American Heart Association.
SOURCE: American Heart Association Annual Meeting, News Release, Nov. 15, 2020; American Medical Association Journal, Nov. 15, 2020