Vascepa, A Prescription Omega-3 Fatty Acid, Shows Heart Health Benefits in High-Risk Populations

Amarin’s Vascepa, an omega-3 fatty acid, shown to lower risk of heart attack, stroke, and heart-related death for adults with high risk for heart disease with elevated triglycerides.

Amarin, a Dublin, Ireland-based company, has announced positive results from its REDUCE-IT trial testing Vascepa, a prescription omega-3 fatty acid, in adults on statins (cholesterol lowering drugs) with heart disease or diabetes and other risk factors for heart disease.

Data presented at the 2018 American Heart Association (AHA) conference in Chicago showed that Vascepa resulted in an overall reduction in important heart-related events by 25%, including:

• 20% reduction in death due to heart related causes

• 31% reduction in heart attack

• 28% reduction in stroke

The study followed 8,179 participants for nearly five years. Almost 58 percent of the trial participants had type 2 diabetes. On November 14, 2019, considering this data from REDUCE-IT, an FDA Advisory Committee voted 16-0 in favor of approving Vascepa for heart disease. 

Vascepa is an FDA-approved therapy for people with very high levels (greater than 500 mg/dl) of triglycerides, which are a type of body fat. In December 2019, the FDA also approved Vascepa as an addition to statins for people with triglycerides over 150 mg/dL and either (1.)  established heart disease, or (2.) diabetes and two or more additional risk factors for heart disease. See below for the updated label.

The FDA did not specify what risk factors are needed to prescribe the medication, though Amarin listed several including age of 50 years or older, current or recent smoking, high blood pressure, low HDL (a form of cholesterol), body mass index (BMI) greater than 25, kidney dysfunction, retinopathy, and several others. This new approval enables broader use of Vascepa to improve heart health in people with diabetes.

For most people in the US with private, Medicaid, or Medicare insurance, Vascepa costs about $3-6 per month with a co-pay card.

Vascepa is an omega 3 fatty acid, similar to those found in a fish oil supplement. However, unlike Vascepa which contains only EPA, fish oil supplements generally contain two kinds of omega-3 fatty acids, EPA and DHA. There have been many clinical trials, such as the ASCEND trial, that have failed to find any heart health benefit from fish oil in people with diabetes. But, these supplements included DHA, which is thought to potentially elevate LDL, the type of cholesterol traditionally associated with worse health outcomes. In the ASCEND trial, participants were also at low risk for heart disease and were taking a low-dose of just 1 gram per day.

In contrast, the REDUCE-IT trial studied a high-risk population and prescribed a higher dose of 4 grams per day. In addition, Vascepa only contains EPA. These might be the reasons this trial showed more positive outcomes. The REDUCE-IT trial studied over 8,000 adults with very high triglyceride levels and statin-controlled LDL cholesterol between 41-100 mg/dl (ADA’s recommended goal for people with diabetes is below 100 mg/dl). Overall, the most commonly reported side effect of Vascepa was joint pain (arthralgia). The press release also notes that the safety profile was similar to other study data on omega-3 fatty acids. 

As people with both type 1 and type 2 diabetes are at increased risk of heart disease, this research around heart-protective therapies is promising. As a relatively low-cost drug, Vascepa may have the potential to help a wide range of people with diabetes and high triglycerides. One thing to note is that individuals on Vascepa will likely be required to take a total of four capsules per day – two capsules, twice a day.