The first study, the longest and largest randomized trial of its kind, looked at whether omega-3 fatty acid supplementation and / or vitamin D supplementation provided any benefit in preventing atrial fibrillation.
Fish oil and vitamin D a. Fibs do not help
Comparing the results between volunteers who took placebo and those who received vitamin supplements, the researchers found no statistically significant difference in the results.
“Atrial fibrillation itself is a major problem, which 10 to 15% of people over the age of 80 know is atrial fibrillation,” Dr. Said Christine Albert, president of the cardiology department at Smit Heart Institute. In Cedar-Sinai, who presented the findings. “It can really worsen the quality of life and result in a lot of adverse consequences. I really hope that it inspires others to do primary prevention tests.”
Primary prevention steps she hopes to investigate further are some lifestyle interventions that prevent atrial fibrillation events.
Fish oil does not reduce heart risk
In a second presentation published Sunday in the Journal of the American Medical Association, researchers found that omega-3 fatty acid supplements did not reduce cardiovascular risk.
It was also a double-blind randomized trial that compared the health of patients who took high-dose omega-3 supplements with those of corn oil taking placebo.
Volunteers were seen for more than two years between June 2017 and January 2020. The study was stopped early it became clear that there was little chance of any benefit from omega 3 fatty acids.
In fact, the rate of gastrointestinal adverse events was more than 25% in the group taking omega-3 supplements, compared to those taking a little more than 15% corn oil.
The Cleveland Clinic’s cardiologist working in the study, Drs. “Several trials have now shown no effect of fish oil on cardiovascular outcomes,” said Steve Nissen. “That test, known as REDUCE-IT, received a large amount of attention, was a ton of publicity, including the FDA label, which reduced this cardiovascular risk.”
In that test, he said, one of the components in fish oil, used the pure form of EPA.
“The question is what’s going on here? What’s the difference between that study and us, and I’m going to be frank, that other test used mineral oil as its placebo. We don’t think it was neutral . ” .
In other words, he thinks the study of mineral oil skewed the results. Mineral oil is a form of liquid paraffin, a derivative of candle wax.
“When taken regularly, mineral oil is bad for you,” Nisen said. “So we think that a study was favorable, not because fish oil was good.”
“In fact, both testing and our testing showed that atrial fibrillation increased – 69% increased risk – with fish oil in our study,” said Nissen. “So, you can make the case that fish oil may not actually be neutral. It can be harmful in some cases.”
This study is consistent with earlier tests.
In 2019, the US Food and Drug Administration approved the fish oil-based drug Wasepa for the prevention of heart attack and stroke.
Nissan hopes the FDA will take a look at these studies and reconsider that decision.
“But it’s hard for the genie to get out of the bottle,”
Assistant Professor of Medicine at Harvard Medical School, Drs. An editorial in the journal that accompanies the study, written by Gregory Curfman, also suggests that the FDA should require subsequent clinical trials of a higher dose of fish oil, such as Vasaspa, Vs. Corn oil in patients at risk of cardiovascular events, “shed more light on this perplexing clinical issue and research question.”