A new study shows that supplementing statin-treated patients with omega-3 does not reduce their risk of major heart problems, NutraIngredients reported on 18 November.
The study was terminated early due to the lack of positive results.
Observational studies had demonstrated a link between dietary consumption of either fatty fish or omega-3 fatty acids and heart health and that circulating concentrations of EPA or DHA were also linked to cardiovascular risk.
Two recent trials had also reported heart health benefits in two trials of purified EPA, NutraIngredients said.
However, other trials studying lower doses of omega-3 fatty acids in a broader range of patients had failed to show a significant reduction in total heart attacks.
The latest trial, titled the ‘Long-Term Outcomes Study to Assess Statin Residual Risk with Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia (STRENGTH)’, evaluated the effects of omega-3 CA on clinical outcomes in patients at high cardiovascular risk.
Omega-3 CA is a carboxylic acid formulation of omega-3 fatty acids (EPA and DHA) that does not need to be taken with a high-fat meal. This results in greater bioavailability compared with standard omega-3 ethyl ester formulations.
A total of 13,078 patients were enrolled at 675 sites in 22 countries in North America, Europe, South America, Asia, Australia, New Zealand, and South Africa between October 2014 and June 2017.
In the trial, patients were given a dose of either omega-3 CA or corn oil. After a follow-up of around 42 months, no significant difference in heart risk was noted between the two groups. In the omega-3 group, 12% had heart issues compared to 12.2% of the corn oil patients.
The trial was stopped prematurely in January 2020 when it became apparent that the clinical benefit was likely to be low and there was evidence of risk, including a higher – although small – chance of atrial fibrillation in the omega-3 CA group, NutraIngredients said.