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Cardiologists may one day have a new tool to prevent heart attacks and strokes in some high-risk patients: a prescription drug containing high doses of EPA, an omega-3 fatty acid contained in fish oil.
A large clinical trial found that the drug, called Vascepa, significantly reduced the rate of cardiovascular events in people with a history of heart disease or type 2 diabetes, according to first results announced Monday.
The results were particularly relevant for people with high triglyceride levels, a type of blood fat linked to an increased risk of heart disease. The new trial, called Reduce-IT, looked at people whose cholesterol levels were well controlled by statins but whose triglyceride levels were still very high. Many cardiovascular experts were skeptical that adding fish oil above the statins would produce a great benefit, if any, because a number of smaller, less rigorous studies had failed over the years.
But the new trial showed that adults treated with statins with high triglyceride levels who had been prescribed high doses of purified EPA had a 25% reduction in their risk of heart attacks, accidents cerebrovascular disorders and other cardiac events. .
"I am very surprised by the magnitude of the results, which are frankly important," said Dr. Michael J. Blaha, director of clinical research at the Ciccarone Center for Heart Disease Prevention at the Johns Hopkins School of Medicine, who was not involved in the study. "My expectations were very low. Many people are legitimately surprised by this.
Fish oil has long been a popular supplement to protect against heart disease. It contains high levels of omega-3 fatty acids, mainly EPA and DHA, which reduce inflammation and lower triglyceride levels. Omega-3 fatty acids also have similar anticoagulant effects to those of aspirin.
But so far, most of the clinical trials involving fish oil in heart patients have not found convincing evidence of its effectiveness. Some argued that the trials were deeply flawed, stating that they were relying on too low doses or that they were failing to recruit the patients most likely to benefit, such as those with high triglyceride levels. Some of the studies were observational, less rigorous than clinical trials, in which different groups of patients receive different treatments. They also used different types of fish oil.
The new trial differed from the precedents in several ways. It focused specifically on two groups of high-risk patients: individuals with a history of cardiovascular events, such as heart attacks, strokes, and angina; and those with type 2 diabetes and other risk factors such as hypertension. Patients also had to have high triglycerides. The baseline median triglyceride level in the subjects was 216 milligrams per deciliter – well above the threshold for what is considered a normal level of 150 milligrams per deciliter. In addition, all patients were taking statins that lower cholesterol.
The intervention in this essay, sponsored by Amarin, was not the typical supplement of fish oil that can be purchased in any supermarket or pharmacy. Vascepa is a prescription medication containing highly purified EPA. On the other hand, fish oil supplements often contain a mixture of EPA and DHA and, in some cases, other oils. EPA and DHA are similar but have slightly different effects. Both can reduce triglycerides, for example, but DHA also tends to increase LDL cholesterol, the so-called bad type associated with heart disease.
The trial recruited 8,179 adults and followed them on average for about five years. In addition to reducing cardiovascular events, the trial revealed that Vascepa was safe and well tolerated. Amarin announced the results on Monday and is expected to present all results and data at an annual conference of the American Heart Association in November.
Dr. Ethan Weiss, a cardiologist and associate professor at the University of California at San Francisco, who was not involved in the study, said the findings confirm the role played by elevated triglycerides in heart disease, both at home and abroad. Earlier tests of fish oil had little or no benefit. He pointed out several caveats: he and others need to see all the data, and the patient population likely to benefit from Vascepa is very specific. Diet and exercise can also reduce triglycerides – especially low carb diets – and it should be investigated if the result on heart risk may be similar to that produced by Vascepa.
"Many questions remain," he said. "But the problem is that it's really huge and I'm wrong. And I am happy to have been wrong and I am excited to have a new path and a set of tools to explore for our patients.
Some experts have warned that Vascepa is not for anyone with heart disease or risk factors. the The drug is currently approved for some patients with exceptionally high triglyceride levels.
"The problem should not choke and take fish oil," said Dr. Michael Shapiro, a researcher on the clinic's website and director of Atherosclerosis Imaging at the University of Toronto. Health and Science. But the group likely to benefit from it includes a large proportion of patients in the cardiology centers.
"The number of people in the world who have atherosclerotic disease or diabetes who take statins and still have high triglycerides is huge," he said. "It has huge implications."
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