Vascepa, A Prescription Omega-3 Fatty Acid, Shows Heart Health Benefits in High-Risk Populations
By Divya Gopisetty and Maeve Serino
Amarin’s Vascepa, an omega-3, shown to lower risk of heart attack, stroke, and heart-related death for adults with high risk for heart disease with elevated triglycerides
A Dublin, Ireland-based company called Amarin has announced positive results from its REDUCE-IT trial testing Vascepa, a prescription omega-3 fatty acid, in adults with heart disease on statins. The study followed participants for nearly five years and found a 25% lower risk for heart attack, stroke, heart-related hospitalization, and heart-related death compared to placebo (“nothing” pill). 25% is a big deal – comparable to statins, which are widely prescribed. Full results will be shared at the American Heart Association meeting in November.
Currently, Vascepa is FDA approved as a therapy that, in addition to diet changes, can reduce severely high triglyceride levels at or above 500 mg/dl. For most people in the US with private insurance, Vascepa costs about $3 per month with a co-pay card.
Fish oil has been a subject of much discussion in the cardiovascular field. Fish oil supplements generally contain two kinds of omega-3 fatty acids, EPA and DHA, and research shows fish oil can lower high triglyceride levels. As we understand it, however, 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 supplmenets 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). While the exact numbers are not yet available, 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 it will likely be required to take two capsules taken twice a day.