by Adam Ismail
OK, we already know eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) omega-3s are good for your heart, so the fact that a new Global Organization for EPA and DHA Omega-3s (GOED)-funded meta-analysis has established that they reduce blood pressure does not seem like earth-shattering news. However, it is actually strategically important for the market.
The study examined the totality of evidence and found that consuming EPA and DHA reduced systolic blood pressure an average of 1.5 mm Hg and diastolic blood pressure 0.89 mm Hg. The effects were even stronger in hypertensive individuals, reaching 4.5 mm Hg reductions. These changes in blood pressure sound small, but studies have shown every 2 mm of reduction can yield a 6 percent reduction in cardiac mortality risk, including reductions in both heart attack and stroke risk.
This study actually used a very large dataset, which is unique for nutrition meta-analyses. The theory behind meta-analyses is that smaller individual studies can have variations in methodological design that yield completely different results, but pooling all of these studies together into a single meta-analysis will give you a glimpse into what the totality of the evidence shows. Of course, this approach has its own limitations because you could be pooling inappropriate studies together—such as those in healthy patient populations with those in critical care units. As a result, many meta-analyses in nutrition only include a handful of studies because it is difficult to find a group of studies that have enough common characteristics to pool.
In this case, 70 randomized, controlled trials were identified that compared changes in blood pressure associated with omega-3 consumption to placebo. This is a large dataset for these types of studies and the fact that an effect was observed is significant because it argues that the evidence base is large, consistent and well-founded. In the face of multiple negative media reports alleging omega-3s have no effect on cardiovascular disease (CVD), this is a study with which it is hard to argue.
However, it is also important strategically for the omega-3 business because it is an effect in blood pressure specifically. Many people do not realize FDA only recognizes a couple biomarkers as surrogate risk factors for CVD risk, including total cholesterol and blood pressure. We have all heard about triglycerides, C-reactive protein, HDL cholesterol, homocysteine and many others, but none of these are accepted by FDA as surrogate markers. This becomes a strategic distinction because FDA views reductions in accepted surrogates as reductions in CVD risk. Changes in these accepted markers can be used for regulatory filings to establish things such as health claims and also become important in discussions about reducing chronic disease risks in setting Dietary Guidelines and Daily Values. Omega-3s are known to have an impact on triglycerides, and many studies have even shown changes in CRP, HDL cholesterol and many others, but this does not help the nutrition industry in getting incontrovertible claims—and has even hindered some pharmaceutical companies when FDA questions the benefits.
The other strategic benefit to establishing a reduction in blood pressure is in how it opens up a new avenue for educating consumers about the benefits of omega-3s. When you have high blood pressure, the first thing doctors will tell you to do is make lifestyle changes such as cutting the salt in your diet, increasing your exercise or cutting out cigarettes. Supplements are never considered a healthy lifestyle intervention by doctors in these situations; instead, they are viewed like pharmaceuticals with a direct pharmacological effect. However, all of these lifestyle changes result in a couple millimeters of reduction in blood pressure levels, just like omega-3s. So now this opens the gate to talking about eating fish or adding an omega-3 supplement as a healthy lifestyle intervention. This is important because these lifestyle interventions are changes consumers are willing to make on a day-to-day basis for long periods of time, rather than viewing them as temporary changes with low compliance rates. This can help support the market by bringing in new consumers who might be skeptical about omega-3 supplements, and keep them in the category for long periods of time.
GOED has filed with FDA for an authorized health claim on the basis of this meta-analysis, so we now await official word to see if FDA agrees. Given all the negative media we have been facing, this study could be important for putting the debate about the value of omega-3s to rest.
Adam Ismail is executive director at Global Organization for EPA and DHA Omega-3s (GOED), where he oversees organizational development for new and existing members. He has more than a decade of experience in the natural health and nutraceutical industries, including work on the founding of an international learning consortium based at Purdue University, and spearheading an overturn of a ban on fish oil imports in Europe.