Results from the AREDS2 Study were released in May this year. The Macular Disease Foundation Australia (MDFA) has adopted its findings and manufacturers of eye health supplements have moved quickly to deliver new products to reflect the updated formula.
The primary purpose of the AREDS2 study, conducted by the American National Eye Institute, was to evaluate whether the addition of lutein/zeaxanthin and/or the omega-3 fatty acids EPA & DHA (fish oil) to the original AREDS formulation provided any further benefit compared to the original AREDS formulation alone, in terms of reducing the risk of progression to the late stage of age-related macular degeneration.
MDFA Chief Executive Officer, Julie Heraghty said the results came as no surprise but were positive because they confirm the value of the original AREDS formulation with some minor changes. “The Foundation has and will remain supportive of an evidence-based approach in relation to supplements. Communicating to patients the importance of diet, the role of supplements, who should be taking the supplement and the correct formula and dose, is very important to ensure the best outcomes,” said Ms. Heraghty.
“What’s important is that the beta-carotene has been removed from the AREDS2 formula because it has been shown to increase the risk of lung cancer, especially in people who smoke or previously smoked. This confirms the position the Foundation has been taking for some time,” said Ms. Heraghty. The study also confirmed that the removal of beta-carotene did not reduce the efficacy of the AREDS2 formula and in fact, led to improved absorption of lutein/zeaxanthin.
beta-carotene has been removed from the AREDS2 formula because it has been shown to increase the risk of lung cancer
On the addition of lutein/zeaxanthin to the AREDS2 formula, Ms. Heraghty said, “this is not surprising – lutein and zeaxanthin are very important anti-oxidants that we know are important for macular health.”
She said the study found the addition of a particular combination of DHA/EPA esters (fish oil) to the original AREDS formulation did not provide any further benefit. However Ms. Heraghty emphasised patients should be encouraged to maintain an eye health diet that includes two to three servings of fish every week. “For people who cannot regularly eat fish, there is possibly still some merit in considering a fish oil supplement as it is very difficult to get adequate long-chain omega-3s from other sources,” said Ms. Heraghty.
The AREDS2 daily dose recommended by the American National Eye Institute comprises:
- Zinc (80 mg as zinc oxide)
- Copper (2 mg as copper oxide)
- Vitamin E (400 IU)
- Vitamin C (500 mg)
- Lutein (10 mg)
- Zeaxanthin (2 mg)
More than 4,000 people participated in the AREDS2 study, making it the biggest study of its kind in the world. As such, Ms. Heraghty said it is extremely important because it provides level 1 clinical evidence to support the use of high dose zinc and anti-oxidant supplements to slow the progression of macular degeneration for those diagnosed with the disease.
Pam Stone, Education Manager at Blackmores said the results from the study were encouraging. “There were no real surprises in the results but they were encouraging, predominantly because the AREDS2 trial reinforced the nutritional approach of supplementing diet with anti-oxidants and zinc to preserve eye health.
Additionally, Ms. Stone said, the study showed that Macu-Vision is still an appropriate supplement for patients needing support to maintain ageing eye health and as a consequence, “have come up with the right formula to support macular health”.
New Products on the Shelves
She said as a result of the AREDS2 findings, Blackmores will release Macu-Vision Plus this month (October), which is based on the original formula with the addition of lutein and zeaxanthin. “To obtain adequate levels of these two nutrients it is necessary to eat approximately half a cup of leafy green vegetables each day. For most of us, especially those who find it hard to get out to buy fresh vegetables, it would be hard to say that we are achieving this,” said Ms. Stone.
For those who are “really confident” they are getting rich dietary sources of lutein and zeaxanthin from their leafy green vegetables, the orginal Macu-Vision formula will remain on the market.
Australian owned company Stiltec was also quick to respond to the study, launching Macutec Essentials – a refined formula “precisely based” on AREDS2 in September. Even the lutein and zeaxanthin are sourced from the supplier that supplied the ingredients for the AREDS2 study.
“For those who want to be absolutely guided by the recommendations of the AREDS2 study, we have gone out of our way to replicate the exact ingredients used in the study,” said Steven Mann, Managing Director of Stiltec.
“Because of the low zinc dosage regulations in Australia, each Macutec Essentials capsule contains half the recommended AREDS2 daily dose.”
Mr. Mann said Stiltec’s first product for macular health, known as Macutec + Omega 3, will remain on the market and he expects it will continue to be popular. “A lot of people already take a fish oil supplement for conditions such as arthritis and heart health, so it’s convenient to have the fish oil in the Macutec capsule as well. Additionally, there is still some question over whether fish oil has a role to play in macular health. The AREDS studies have only looked at people who already have advanced disease, not at people at risk of the disease. And although the AREDS2 study showed there was no additional efficacy from including fish oil, other studies have shown a benefit from fish oil on macular health.”
He added “for some patients Macutec Essentials have the benefit of being almost half the size of Macutec + Omega 3, which makes them easier for some elderly people to swallow.
Bausch + Lomb has also launched a new formula which is based on the new AREDS study. PreserVision AREDS2 Formula is based on the company’s original PreserVision vitamin and mineral supplement with the addition of lutein and zeaxanthin (replacing beta-carotene). Like Stiltec’s Macutech, this new formula also includes 1,000 mg Omega-3 fatty acids.
Ms. Heraghty said any patients who are considering changing their supplements or diet should do so in consultation with their doctor.
Additionally, she said patients affected by macular degeneration, whether in the early stages, the more progressed stages with vision loss, or who have a family history of the disease, should be directed to the Macular Disease Foundation Australia. “The Foundation collates all the evidence-based research and translates it into meaningful messages for the public and professionals. We can also provide practical advice and publications on diet and supplements, as well as support for those needing low vision aids or services.”
She reminds all optometrists that the Foundation provides a whole range of resources and publications for eye care professionals free of charge. One of the easiest ways to refer patients to the Foundation is with the bookmark, printed with the Foundation’s contact details. “When people first find out they have symptoms of macular degeneration they have many questions. We have the resources and time to guide them, and in doing so can take much of the pressure off busy eye health practitioners,” she said.
The Macular Disease Foundation Australia can be contacted on (AUS) 1800 111 709 or visit www.mdfoundation.com.au