Confidence Drops in Prescription-Strength Fish Oil
More than 13,000 patients, treated in centers around the world, received Epanova or a placebo pill containing corn oil. All the patients had conditions putting them at “high cardiovascular risk”. For example, they were being treated with cholesterol-lowering statins and either had blockages in the coronary arteries, or arteries in the brain or legs, or were at risk of heart disease due to conditions like diabetes or risk factors related to the mode. life like smoking.
The trial registration began in 2014. The trial ended in January 2020, the Lincoff group said.
During this time, more than 1,600 patients experienced some kind of cardiac event. But Epanova’s use did not reduce deaths from heart disease, heart attacks, strokes, the need for stents or bypass surgery, or hospitalization for angina.
There was even a downside to the treatment: Researchers claim that using prescription fish oil appeared to be linked to an increased risk of a common abnormal heart rhythm called atrial fibrillation.
But if Epanova seems to confer no benefit, why did heart patients who received another prescription omega-3 drug, Vascepa, seemingly improve their health?
According to Curfman, the answer may lie in the design of the trial.
Vascepa contains a purified form of EPA known as ethyl icosapent. The clinical trial which appeared to validate the effectiveness of Vascepa lasted 5 years. The researchers found that the use of the drug was linked to a 25% reduction in various cardiac events compared to placebo – in this case, mineral oil.
“Why did these 2 high-quality clinical trials, both using the same high dose of omega-3 fatty acids, come to opposite conclusions?” Asked Curfman.
The choice of a placebo – mineral oil or corn oil – might help explain the difference, he said. Perhaps Vascepa “did not reduce the risk of cardiovascular events, but on the contrary, the comparator, mineral oil, increased the risk of cardiovascular events,” theorized Curfman. It could create the illusion that Vascepa helped patients, he told himself.
There is some evidence that mineral oil can increase levels of bad LDL cholesterol, noted Curfman.
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