Could null pharma trials negatively impact omega-3 dietary supplements?
Results from a study using Pronova BioPharma Norge’s Omacor product indicated no heart benefits, compared to placebo, for people at high risk of cardiovascular events.
The study’s findings are published in the high-profile New England Journal of Medicine.
Despite this being a pharmaceutical product, the researchers behind the Outcome Reduction with Initial Glargine Intervention (ORIGIN) Trial concluded: “Daily supplementation with 1 g of n–3 fatty acids did not reduce the rate of cardiovascular events in patients at high risk for cardiovascular events.”
Scope for confusion
Commenting on the study and its findings, Harry Rice, PhD, vice president of regulatory and scientific affairs for omega-3 trade association GOED, told NutraIngredients-USA that he expects more studies like the current one. “Unfortunately, I think we'll see many with similar results, null that is.
“While the potential exists to have a negative impact on the reputation of the dietary supplement market, GOED will make a concerted effort to educate the public about the possible reasons.
“One of the more likely reasons for the present results, as well as the results from studies like last April's flawed meta-analysis, is that subjects in trials today are typically taking a cocktail of cardiovascular drugs, the likes of which were not available in earlier trials reporting positive benefits,” said Dr Rice.
“Thus said, any potential benefits of EPA & DHA are being blocked by the subjects' pharmacological regimens. This does not mean that EPA & DHA are no longer providing a benefit(s). What it means is that the studies are under-powered such that effects are not being detected.”
Study details
The ORIGIN researchers recruited 12,536 patients at high risk for cardiovascular events with diabetes, impaired fasting glucose, or impaired glucose tolerance. Participants were randomly assigned to receive either placebo or a daily one gram capsule with at least 900 mg omega-3 fatty acid ethyl esters.
The participants were also taking “more concomitant cardioprotective therapies”, said the researchers, and this may explain why, after six years of “supplementation” the incidence of death from cardiovascular causes was reduced, “thereby reducing the statistical power to detect any effect of n–3 fatty acids”.
While no effects were observed between the omega-3 group and the placebo group for rates of major vascular events, death from any cause, or death from arrhythmia, the researchers did record a significant reduction in triglyceride levels in the omega-3 group, compared to the placebo group.
“Whether similar [null] results would have been observed at higher doses is unknown,” wrote the researchers. “Furthermore, these findings may not be relevant to dietary recommendations to consume more fish, because dietary change not only increases the intake of foods containing n–3 fatty acids but is also associated with a reduction in the consumption of foods such as red meats, which may be harmful.”
The study was supported financially by Sanofi.
Source: The New England Journal of Medicine
Published online ahead of print, doi: 10.1056/nejmoa1203859
“n–3 Fatty Acids and Cardiovascular Outcomes in Patients with Dysglycemia”
Authors: The ORIGIN Trial Investigators
