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More than 13,000 sufferers, handled at facilities world wide, got both Epanova or a placebo tablet containing corn oil. All sufferers had circumstances placing them at at “high cardiovascular risk.” For instance, they have been being handled with ldl cholesterol-lowering statins and had both blockages of the coronary arteries, or arteries in the mind or legs, or have been in danger for coronary heart illness due to circumstances resembling diabetes or life-style threat elements like smoking.
Enrollment into the trial started in 2014. The trial was terminated in January of 2020, Lincoff’s group mentioned.
Over that time frame, over 1,600 sufferers skilled some form of cardiac occasion . But using Epanova didn’t lower deaths from coronary heart illness, coronary heart assault, stroke, the necessity for stents or bypass surgical procedure, or being hospitalized for angina.
There was even one draw back to the therapy: Researchers say that use of the prescription-strength fish oil appeared tied to an increase in the chance for the frequent irregular coronary heart rhythm referred to as atrial fibrillation.
But if Epanova seems to confer no profit, why did coronary heart sufferers given one other omega-Three prescription drug, Vascepa, seemingly get a well being increase?
According to Curfman, the reply might lie in trial design.
Vascepa incorporates a type of purified EPA referred to as icosapent ethyl. The medical trial which appeared to validate Vascepa’s effectiveness lasted 5 years. Researchers discovered that use of the drug was tied to a 25% discount in quite a lot of cardiac occasions when in comparison with 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?,” Curfman requested.
The alternative of placebo — mineral oil or corn oil — may assist clarify the discrepancy, he mentioned. Perhaps Vascepa “did not reduce the risk of cardiovascular events, but instead, the comparator, mineral oil, increased the risk of cardiovascular events,” Curfman theorized. That may create the phantasm that Vascepa helped sufferers, he reasoned.
There is a few proof that mineral oil can increase ranges of LDL ‘unhealthy” ldl cholesterol, Curfman famous.
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