The STRENGTH Trial
There has been intense interest in omega-3 fatty acid research. The REDUCE-IT trial had demonstrated that one particular prescription formulation of an omega-3 fatty acid, icosapent ethyl, significantly reduced cardiovascular events in a randomized, placebo-controlled trial. Previously, a separate, independent randomized trial called JELIS also showed a significant reduction in cardiovascular events with icosapent ethyl, although without a placebo (a so-called open-label randomized trial with blinded adjudication of endpoints). In contradistinction to the experience with icosapent ethyl, which is a highly purified formulation of the omega-3 fatty acid eicosapentaenoic acid (EPA), trials of mixtures of omega-3 fatty acids have largely been negative with respect to their primary endpoints. Most recently, the STRENGTH trial was published, which evaluated a specific formulation of a mixture of omega-3 fatty acids and found absolutely no benefit versus a placebo. From a distance, these results may seem contradictory to the positive results of both REDUCE-IT and JELIS. However, it is important to understand the science and that not all omega-3 formulations are equivalent. The actual formulation and whether it is subject to oxidation can greatly influence whether there is any beneficial biological effect of omega-3 fatty acids. Furthermore, the exact type of omega-3 fatty acid (that is EPA versus docosahexaenoic acid, or DHA, for example) may be important. As well, the dose matters, as there may be threshold effects such that certain serum and tissue levels must be achieved for there to be cardiovascular benefit. Thus, right now the evidence is in support of use of prescription icosapent ethyl and not of other formulations, including dietary supplements. In addition to two separate, independent randomized clinical trials supporting icosapent ethyl, there have been two mechanistic studies as well. CHERRY used intravascular ultrasound to show plaque regression with icosapent ethyl in a randomized trial that did not use placebo. EVAPORATE studied icosapent ethyl in a randomized trial with a placebo and found significant benefits with respect to plaque composition and progression using noninvasive CT angiography. Thus, four separate randomized clinical trials—two clinical and two mechanistic—provide robust evidence for icosapent ethyl. The results from STRENGTH merely demonstrate that the specific compound studied in that trial was not beneficial and should not be extrapolated to apply to EPA, which has a robust evidence base.
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