Sept. 25, 2018 -- A prescription pill that contains large doses of an omega 3 fatty acid found in fish oil staved off heart attacks and strokes in folks with a history of heart disease or type 2 diabetes.
In the large clinical trial, the results were particularly potent for people with high triglycerides, a blood fat long linked to an increased risk of heart disease, the New York Times reported Monday.
The researchers focused on people whose cholesterol levels were controlled with statins, but whose triglyceride levels were still high. Because many smaller studies had not produced much evidence of any benefit in adding fish oil supplements to statin use, the hopes of heart experts were not high.
But the new trial, to be presented in November at the American Heart Association's annual meeting, showed that these patients saw a 25 percent drop in their relative risk of heart attacks, strokes and other cardiac events compared to a control group of patients who received a placebo.
"I'm very surprised by the magnitude of the results, which quite frankly are large. My expectations were very low. A lot of people are legitimately surprised by this," Dr. Michael Blaha, director of clinical research at the Ciccarone Center for the Prevention of Heart Disease at Johns Hopkins Medical School, told the Times.
"Fish oil has long been a popular supplement to protect against heart disease. It contains high levels of omega-3 fatty acids, primarily EPA and DHA, which reduce inflammation and lower triglyceride levels," explained Blaha, who was not involved in the trial. "Omega-3 fatty acids also have blood-thinning effects similar to those of aspirin."
The new trial differed from previous studies in two aspects, the newspaper reported. First, it focused on a specific group of high-risk patients: People with a history of heart disease, diabetes or heart risk factors. In addition, all of the patients were on statins, which lower cholesterol.
Secondly, Vascepa was not the typical fish oil supplement that can be bought in any drugstore or supermarket. Manufactured by Amarin, Vascepa is a prescription drug that contains highly purified EPA, according to the Times.
Fish oil supplements often contain a mixture of both EPA and DHA and, in some cases, other oils. Both EPA and DHA can lower triglycerides, but DHA also tends to raise "bad" LDL cholesterol, the newspaper said.
In the trial, more than 8,000 patients were followed for about five years, during which the drug was well tolerated and safe, the researchers noted.
Dr. Ethan Weiss, a cardiologist and associate professor at the University of California, San Francisco, told the Times that the findings carried a few caveats. All of the data remains to be seen, and the group of patients most likely to see a benefit is very specific, added Weiss, who was not involved in the study.
Vascepa is now only approved for certain patients who have very high triglyceride levels, the newspaper said.
"The worried well shouldn't run out and take fish oil," said Dr. Michael Shapiro, a site investigator for the trial and director of Oregon Health and Science University's Atherosclerosis Imaging Program.
But, "the amount of people around the world who have atherosclerotic disease or diabetes who take a statin and still have elevated triglycerides is enormous," he said. "This has huge implications."