The STRENGTH trial for Epanova, omega-3 carboxylic acids, has been discontinued due to its low likelihood of demonstrating a benefit to patients with mixed dyslipidaemia who are at increased risk of cardiovascular disease, according to a press release from AstraZeneca, manufacturers of Epanova. The decision was made following the recommendation from an independent Data Monitoring Committee.
STRENGTH is a large-scale, global CV outcomes trial designed to evaluate the safety and efficacy of Epanova compared to placebo, both in combination with standard-of-care statin medicines.
Mene Pangalos, EVP, BioPharmacerticals R&D, AstraZeneca, said in the release: “It was important to assess the potential benefit of Epanova in mixed dyslipidaemia. We are disappointed by these results, but we remain committed to addressing the needs of patients in the cardiovascular space where we have an extensive pipeline.”
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Steven E. Nissen, MD, Study Chair for the STRENGTH trial and Chief Academic Officer for the Heart and Vascular Institute at Cleveland Clinic, added: “The academic leadership of the STRENGTH trial is obviously disappointed in this result, but we are very proud to have had the opportunity to answer this important scientific question. We are also grateful for the opportunity to conduct the STRENGTH trial as an exemplary collaboration between academic physicians and industry.”
Full data will be presented at a forthcoming medical meeting.
William S. Harris, Ph.D., Founder of OmegaQuant, shared his thoughts with WholeFoods: “We are disappointed with this news, but we don’t yet have the full story. All we know for now is that there were no major differences between the two groups. However, there is still a lot of work and analysis to do, which will likely take the better part of this year. I would anticipate the final results being presented during the American Heart Association Meeting in November.
“In the meantime,” Dr. Harris continued, “there could be many reasons that this study did not go the way most people thought it would. 1) The difference in the form of omega-3 could have been a factor; 2) the placebo that was used could also have been a factor; 3) pure EPA might be more effective than EPA and DHA together in this context.”
Chris Gearheart, Director, Member Communications & Engagement, GOED, equally expressed surprise. He explained: “This announcement is surprising because a recent meta-analysis found that EPA+DHA reduces the risk of cardiovascular events, and that the protective effect increases with dosage. Because STRENGTH used a high dose (4g/day), there were reasons to expect positive results. When the results of this trial are made public, it will be important to examine them in the context of the totality of the largely positive existing research on the subject.”