JAN 2014

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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20 EW NEWS & OPINION January 2014 AREDS2 updates AMD nutritional supplement by Erin L. Boyle EyeWorld Senior Staff Writer Emily Chew, MD A changed formulation of the supplement for age-related macular degeneration has been announced, with the new formulation already available on the market T he latest Age-Related Eye Disease Study (AREDS), AREDS2, has added lutein and zeaxanthin to the first AREDS nutritional supplement for treating age-related macular degeneration (AMD). The new study found that adding omega-3 fatty acids did not improve or harm patients with the disease, while lutein and zeaxanthin were a safe alternative to beta-carotene. New AREDS2 formulations are already on the market, including the TOZAL formulation by FOCUS Laboratories (North Little Rock, Ark.) and PreserVision AREDS 2 Formula (Bausch + Lomb, Rochester, N.Y.). The first AREDS trial was launched by researchers at the National Institutes of Health (NIH)/National Eye Institute (NEI) in 1992 and concluded in 2001, with AREDS2 launched in 2006. "Millions of older Americans take nutritional supplements to protect their sight without clear guidance regarding benefit and risk," said Paul A. Sieving, MD, NEI director, in a press release from the NEI. "This study clarifies the role of supplements in helping prevent advanced AMD." Lead investigator on the studies, Emily Chew, MD, deputy director of the NEI Division of Epidemiology and Clinical Applications, and the NEI deputy clinical director, said in an interview that AREDS2 has confirmed that diet plays an important part in AMD treatment. Multiple studies have found that people who eat green leafy vegetables high in lutein and zeaxanthin, such as spinach, collard greens, and kale, have lower rates of disease. "I think it's clear from this study that nutrition does have a role in the treatment of macular degeneration because we see these treatment effects from the randomized trial," she said. "What's also interesting is this is a highly nourished group of American ophthalmology, optometry academies form joint initiative T he American Academy of Ophthalmology and the American Academy of Optometry have formed a joint initiative to "work together to better prepare and support their members in delivering the highest quality eyecare," according to a news release. The two organizations hope this initiative will help meet the increasing eyecare needs of the growing aging population in the U.S. The programs will be in development in the next 12 to 18 months, with a formal launch planned for 2015. "This effort marks the first-ever large-scale, organized effort within the optometry and ophthalmology professions in support of joint educational initiatives," the release said. In addition to the aging baby boomer population, which could greatly expand the need for care, healthcare reform could significantly increase the amount of patients who will need eye doctors. "More and more ophthalmologists are practicing with optometrists in the same point-of-care environment and are seeking information and models that will optimize the impact for patients," said David W. Parke II, MD, chief executive officer of the American Academy of Ophthalmology, in the release. "The better prepared our two professions are and the more effectively they work together, the better care we will be able to provide for all patients." EW individuals and if you look at the patients who have the lowest intake of lutein/zeaxanthin found on the baseline of the dietary questionnaire, they had the most beneficial effects from supplementing with lutein/zeaxanthin. "So clearly, you are what you eat," Dr. Chew said. The studies The original AREDS trial involved 4,757 participants, who were 55 to 80 years old at enrollment. Of 4,203 surviving participants, 3,549, or 84%, took part in a five-year followup period. AREDS2 included 4,203 participants between the ages of 50 and 85. "Because the original AREDS trial established that the formulation does not benefit people with no AMD or early AMD, the AREDS2 trial was limited to people with intermediate AMD in both eyes, or intermediate AMD in one eye and advanced AMD in the other eye," a NEI released stated. Overall effects of lutein/zeaxanthin and omega-3 fatty acids docosahexaenoic acid (DHA) and its precursor eicosapentaenoic acid (EPA) were evaluated through randomly assigning study members to one of four treatment groups— control (AREDS formulation only); lutein/zeaxanthin added; DHA/EPA added; lutein/zeaxanthin and DHA/ EPA added. In addition, "the effects of adjusting beta-carotene and zinc levels were evaluated in a secondary randomization. Participants who chose to take AREDS (all but 19) were given the option to keep taking the original formulation or be randomly assigned to receive (1) the original formulation, (2) AREDS without beta-carotene, (3) AREDS with low zinc, or (4) AREDS with low zinc and no beta-carotene," the NEI reported. Study participants and researchers were unaware of treatment status until the end of the study. The results AREDS2 found that adding DHA and EPA or lutein and zeaxanthin to the original AREDS formulation with beta-carotene had no additional overall effect on the risk of advanced AMD, but those who took the sup- plement with lutein/zeaxanthin and without beta-carotene had a modest reduction in the risk of advanced AMD over those who took it with beta-carotene. Results show that beta-carotene, which has been a problematic antioxidant in the original formulation because of its link to a higher incidence of lung cancer in cigarette smokers, should be substituted with lutein and zeaxanthin. Substituting beta-carotene is important, Dr. Chew said, because of the high rate of people who have smoked previously or are currently smoking, which was 50% for former smokers in this study and 70% in the AMD population as a whole who have smoked or are smoking. "I don't think people realize that, but that's a very important aspect," she said. Researchers wanted to use lutein in the first AREDS, but it was not commercially available at that time, Dr. Chew said. Of note is that while beta-carotene does not naturally exist in the eye, the antioxidants lutein and zeaxanthin do. They can be found in the retina and lens, according to information from the NEI. "[This study] refined the first AREDS formulation by substituting beta-carotene with lutein/zeaxanthin, which I think improves safety and also increases efficacy as well. There is definitely good biological sense to consider lutein/zeaxanthin, and they may be very protective for other reasons," Dr. Chew said. The study also found that giving an omega-3 fatty acid—the DHA/ EPA component—did not alter results of advanced AMD. However, eating fish is still important for this patient population. The first AREDS found that two servings of fish a week could have an almost 40% to 50% reduction in risk of the disease, Dr. Chew said. It still makes sense to recommend that patients continue to have a diet replete with fish. The best patients to receive the updated formulation are those at risk for advanced AMD, for instance those with bilateral large drusen or advanced disease in one eye. This study supported the AREDS finding that the supplement does not stop earlier stages of AMD. continued on page 22

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