Vascepa lowers chance of heart attack and stroke by 25 percent in patients already on statins.
Many persons take fish oil supplements based on claims of them boosting heart health. According to data collected as part of the National Health Interview Survey, published in February 2015 in the National Health Statistics Report, that number is more than 18 million adults in the United States alone.
According to a publication published in May 2013 in The New England Journal of Medicine, evidence that it actually works has been mixed. But data from a new clinical trial indicates that a type of omega-3 fatty acid found in fish oil may reduce the chances of major cardiovascular events in high-risk patients.
This week, the biopharmaceutical company Amarin announced early research results indicating that its prescription fish oil medication Vascepa may lower the rate of heart attack, stroke, and other cardiovascular events by 25 percent in patients with heart disease or type 2 diabetes (and therefore at elevated risk of suffering a cardiac event at the outset of the study) who are already taking statins to lower their cholesterol levels.
“Having a drug that can reduce cardiac events in patients who are already on a statin with LDL levels [the bad type of cholesterol] already at goal is an incredible, game-changing breakthrough, particularly for someone who has heart disease or diabetes with multiple risk factors,” says study investigator Robert Busch, MD, an endocrinologist and director of clinical research at Albany Medical College in New York.
“It changes what we do. Even today walking in exam rooms, I prescribed the drug when I hadn’t before because of these outcomes.”
Vascpea Cut Risk of Cardiac Events in Those Already at Elevated Risk by 25 Percent
Over the course of about five years, researchers followed 8,179 patients with higher cardiovascular risk who were being treated with statins to control bad cholesterol levels. Their median baseline low-density lipoprotein (LDL) choleterol levels were at a healthy 75 milligram/deciliter (mg/dL).
(An LDL measure less that 100 is considered optimal, according to the Cleveland Clinic. High LDL levels can lead to clogged arteries, which raise risk of heart attack and stroke.)
Still, trial participants did have consistently high levels of triglycerides, the most common type of fat in the body. High triglyceride levels have also been linked to heart disease, according to the American Heart Association. The median base line for patient triglycerides in this study was 216 mg/dL, whereas a healthy level is less than 150 mg/dL.
Individuals also had either previously diagnosed cardiovascular disease or diabetes with at least one other cardiovascular risk factor, such as high blood pressure.
Half the participants received a 4-gram capsule of the fish oil supplement Vascepa each day while the other half received a placebo. At the end of the trial period, the group taking Vascepa had an approximately 25 percent lower risk of major cardiac events — such as cardiovascular death, heart attack, nonfatal stroke, coronary revascularization, or hospitalization from unstable angina (a condition where the heart doesn’t get enough blood flow and oxygen) — compared with the individuals taking the placebo.
The Results Are Promising, But They’re Yet to Be Published and Questions Remain
Sarah Samaan, MD, a cardiologist with Baylor Regional Medical Center in Plano, Texas, notes that while results sound “extremely promising,” the study has not been officially published yet, and so many specifics are not yet known.
“For instance, Vascepa is currently used and FDA [Food and Drug Administration]-approved to lower triglycerides,” says Dr. Samaan, who was not involved in the research. “Was the benefit due to the effect on triglycerides or to something else entirely?” says
She stresses that it’s impossible to identify who will specifically benefit from Vascepa, other than those who are already taking it for high triglycerides.
“Also, whether the effects will translate into benefits for people not on statins remains to be seen,” Samaan says.
The new data will be presented at the 2018 Scientific Sessions of the American Heart Association (AHA) on November 10, 2018, in Chicago.
Not All Fish Oil Drugs and Supplements Are Equal
Another important point is that Vascepa is a prescription medication. The conclusion of these findings does not mean the same conclusion can be made for all fish oil drugs and supplements.
Vascepa contains only icosapent ethyl, a form of omega-3 fatty acid called EPA (eicosapentaenoic acid). Other over-the-counter fish oil products and prescription fish oil drugs, such as Lovaza, contain EPA and DHA (docosahexaenoic acid), another type of omega-3 fatty acid.
A selling point for Vascepa, according to Samaan, is that the medication does not raise LDL, whereas fish oil with the DHA component intact will actually tend to raise LDL, especially in people who start out with high triglycerides.
In a statement, Craig Granowitz, MD, senior vice president and chief medical officer of Amarin, remarked that the results of this research could not be generalized to apply to products that contain DHA. Still, he highlighted that another large investigation from Japan found that EPA added to low-dose statin therapy showed significant cardiovascular event reduction.
“The conclusion is that this study’s findings probably will not provide any rationale for taking over-the-counter fish oil or other forms of omega-3 supplements,” Samaan says.
According to Dr. Busch, while fish oil has been controversial, the outcome of this investigation are decisive. “There are several studies in medicine that really change what we do on a daily basis, and this is one of them,” he says.