Greater than 13,000 sufferers, handled at facilities around the globe, got both Epanova or a placebo tablet containing corn oil. All sufferers had situations placing them at at “excessive cardiovascular threat.” For instance, they have been being handled with cholesterol-lowering statins and had both blockages of the coronary arteries, or arteries within the mind or legs, or have been in danger for coronary heart illness due to situations comparable to 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 stated.
Over that time period, over 1,600 sufferers skilled some sort of cardiac occasion . However the usage of Epanova didn’t lower deaths from coronary heart illness, heart attack, 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 within the threat for the frequent irregular coronary heart rhythm known as atrial fibrillation.
But when Epanova seems to confer no profit, why did coronary heart sufferers given one other omega-3 prescription drug, Vascepa, seemingly get a well being enhance?
In accordance with Curfman, the reply could lie in trial design.
Vascepa incorporates a type of purified EPA often known 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 — on this case, mineral oil.
“Why did these 2 high-quality medical trials, each utilizing the identical excessive dose of omega-3 fatty acids, come to reverse conclusions?,” Curfman requested.
The selection of placebo — mineral oil or corn oil — would possibly assist clarify the discrepancy, he stated. Maybe Vascepa “didn’t cut back the danger of cardiovascular occasions, however as an alternative, the comparator, mineral oil, elevated the danger of cardiovascular occasions,” Curfman theorized. That may create the phantasm that Vascepa helped sufferers, he reasoned.
There’s some proof that mineral oil can enhance ranges of LDL ‘unhealthy” ldl cholesterol, Curfman famous.