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Clinicians urge proactive approach in light of AREDS2 results
“At Issue” asked a panel of experts: In light of the AREDS2 conclusions that replacing beta carotene with lutein and zeaxanthin improved the supplement’s safety and efficacy, have you changed your recommendations to patients?
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Changed
Diana L. Shechtman, OD, FAAO: AREDS2 is one of the largest evidence-based medicine studies to date, evaluating about 4,000 subjects with intermediate age-related macular degeneration. Its results have changed recommendations for our patients today.
The primary goal was to evaluate if the addition of lutein/zeaxanthin (L/Z) and/or omega-3 to the original AREDS formulation would further reduce progression of AMD. The study also evaluated the impact of eliminating beta carotene and reducing zinc dosage. Other outcomes such as progression of cataracts, cardiovascular disease and moderate vision loss were also assessed.
The primary results showed no significant reduction in progression of the disease among the different groups. Yet, statistical analysis of exploratory data did show distinct outcomes.
One outcome was that the addition of L/Z was associated with a 10% decrease in progression of the disease. It was also determined that the addition of L/Z to an AREDS formula without beta carotene had a more dramatic reduction (18%) toward the risk of progression. Although serum levels of lutein increased twofold among subjects in L/Z groups, the increase was damped when L/Z was given in an AREDS formula with beta carotene. This was likely due to competition. In addition, the subgroup with the lowest quintile of dietary intake for L/Z exhibited even more benefit, demonstrating a 26% reduction in progression of the disease.
Diana L. Shechtman
Of note, a previous study (Physicians’ Health Study) had found that subjects taking high levels of beta carotene had equivalent prevalence of AMD compared to those taking a placebo, showing no real benefits of beta carotene on AMD. This indicates that beta carotene may not have the positive impact on AMD that we once believed.
With regard to another outcome, studies such as Beta-Carotene and Retinol Efficacy Trial (CARET)/Alpha-Tocopherol Beta Carotene (ATBC) have already demonstrated an increase incidence of lung cancer among smokers taking high levels of beta carotene. In regard to the AREDS 2 study, although there were no differences in mortality across any of the groups, beta carotene did show a risk of lung cancer among those subjects who previously smoked.
Thus, the AREDS 2 formula using L/Z to replace beta carotene shows a benefit toward further reducing progression of AMD for my patients with intermediate AMD. In fact, among my patients who likely have a low dietary L/Z intake, this impact would be even greater. This was justified by the AREDS2 exploratory, suggesting that L/Z has a role in AMD management and that it should replace beta carotene in the AREDS formula.
I always believe that it is crucial to keep in mind that my role as an optometrist includes a proactive approach, ensuring decreased disease prevalence and progression. It is my duty to ensure that my patients take preventive measures whenever possible.
Management of my patients includes counseling with regard to proper diet, nutrition supplements and modifying risk factors. In addition, I feel that any decisions on proper patient management should always be made on an individual basis.
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No change
Jeffrey Anshel, OD, FAAO: I have not changed my recommendations following the release of the Age-Related Eye Disease Study 2 results.
Jeffrey Anshel
First, the affected population in the AREDS studies (both) are those with late-stage disease, which is not the bulk of my patient demographic. Lutein and zeaxanthin have been established as critical nutrients in many other studies, so they have been a part of my recommendation for a long time.
Second, I feel that a full-spectrum multivitamin and mineral supplement is more appropriate for the older patient. Many nutrients support eye health. The product that I typically recommend does not contain beta carotene, anyway.
Despite that, I do not hesitate to still say that “Carrots are OK to eat, but they won’t change your eyesight” to my patients. I always try to address the “myth” of carrots linked to better vision and have them eat the diet that will provide the best sources of lutein and zeaxanthin.
If my patients are smokers, taking beta carotene is the least of their problems. I suggest that they are wasting their money on vitamins because smoking wipes out all the benefits of nutritional supplements.
If someone is a fish eater – not deep-fried shrimp, but oily fish such as salmon, tuna and sardines – I do not recommend additional omega-3s. However, on days that they do not eat fish, one 1,000-mg (180 mg EPA/120 mg DHA) pill is fine. It does not matter if it is triglyceride or ethyl ester, as long as they take it with a fatty meal. I also tell them to reduce their intake of vegetable oils and sugar, both of which are pro-inflammatory.
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Concerns with study
David W. Nelson, OD, MBA: The one firm recommendation that came out of AREDS2 was the confirmation that beta carotene from the original AREDS1 formulation recommendation causes lung cancer (mostly in smokers) and should be removed in favor of carotenoids.
David W.
Nelson
I prescribe a full multivitamin with or without zinc based upon genetics, plus lutein, zeaxanthin and mesozeaxanthin for my AMD patients. This is based upon several studies, not just AREDS1 and AREDS2. I also prescribe triglyceride fish oils.
In addition, I encourage proper nutrition and exercise and prescribe blue-blocking lenses with UV protection, particularly in post-cataract patients.
Recently, Primary Care Optometry News carried an excellent article on the difficulty of randomized clinical trials for nutritional supplements and how challenging it is for researchers to design and conclude a study of nutritional supplements on a disease process that can progress over decades (“Traditional randomized clinical trials not suitable for nutritionals,” October 2014). Large, randomized nutritional clinical trials studying the effects of supplements such as AREDS have these limitations, which I feel should concern prescribing doctors.
The first issue was the number of study arms in AREDS2 – only the secondary randomization showed statistical significance that lutein and zeaxanthin helped, particularly in deficient individuals.
The second issue is the formulations of the studied supplements – zinc in an oxide form and fish oils in an ethyl ester form. An oxide form of zinc may be the least absorbed (while cheapest) form of zinc. The ethyl ester fish oils used in the study are known to be difficult for the body to absorb and possibly contributed to their ineffectiveness.
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Changed before study results released
Kimberly Reed, OD, FAAO: I discontinued recommendations for beta carotene long before the AREDS2 results came out, based largely on several other smaller studies showing the superiority of the other carotenoids, specifically lutein and zeaxanthin, as compared to beta carotene, in enhancing macular pigment density.
Kimberly Reed
Because of a lack of a universal definition of “past” or “former” smoker and the increased risk of lung cancer seen in smokers and former smokers, there seems to be no scientific evidence that beta carotene should continue to appear in eye-specific vitamins. Importantly, the vast majority of over-the-counter, drugstore and superstore products contain beta carotene as the vitamin A source, and it has been my experience that very few patients are aware of the increased risk.
This is another essential reason why we as eye care providers must make specific product recommendations to our patients who wish to adopt nutrition and/or supplements as complementary therapeutic or preventive therapy.
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Focus on preventing, slowing AMD
Jeffry D. Gerson, OD, FAAO: The AREDS2 was a landmark study undertaken by the National Eye Institute. The focus of the study was to look at patients with category 3 or 4 dry AMD and see if conversion to advanced AMD or loss of vision could be prevented. The new components in the study vs. the original AREDS were lutein and zeaxanthin, omega-3 fatty acids and altered dosages of zinc and beta carotene.
Jeffry D. Gerson
After analysis, we did find that lutein and zeaxanthin were beneficial in a subset of patients, likely to be similar to many of the advanced dry AMD patients we see. That is good news.
Even with AREDS2, the majority of people that are going to convert still convert and get worse. Once they get to a certain stage of AMD, the prognosis is less than favorable despite any treatment arm in AREDS2.
So, as optometrists, this presents us with an opportunity spelled out in black and white. As much as we want to help patients with more advanced dry AMD, we need to really focus on the patients we are more likely to see. Those are the ones with early AMD or even without AMD but with risk factors (such as genetics, smoking, high BMI, to name a few).
Not getting AMD or not getting advanced dry AMD are the best ways to prevent vision loss from AMD. AREDS2 did not address this, which does not change the fact that we need to tune into primary prevention (preventing AMD in the first place) or secondary prevention as soon as AMD develops and not let patients get to higher-risk, more advanced stages of the disease.
Is AREDS2 optometry friendly? Yes, it is, because it gives a plan to help patients that we can employ. Is it the most patient friendly? Not really. We can provide the most patient friendly treatment by more aggressively recommending preventive measures such as lifestyle changes (healthier diet, more exercise, lower BMI), general medical well-being (controlling hypertension and other systemic conditions), supplements where needed and good patient education.