AREDS2 Study Highlights – 2013

The AREDS2 trial was conducted to determine if the AREDS formula could be improved.

The primary objective of AREDS2 was to determine if adding lutein + zeaxanthin, DHA + EPA (omega-3 fatty acids), or both to the AREDS formulation would help reduce the risk of developing advanced AMD.

Secondary objectives of the AREDS2 study were to evaluate the effect of eliminating beta-carotene, lowering zinc doses, or both in the AREDS formulation. To view the AREDS 2 formula recommendation from the National Eye Institute based on the AREDS2 study, Click here >>


 

AREDS2: the EVIDENCE continues to grow 1


Efficacy 1

Subgroup analysis* indicated that substituting lutein and zeaxanthin for beta-carotene may further decrease the risk of AMD progression in subjects taking lutein/zeaxanthin and no beta-carotene vs. subjects taking beta-carotene and no lutein/zeaxanthin

In this post hoc analysis, risk reduction was based on a hazard ratio of 0.82 (P=0.02).


Demonstrated Safety 1

Substituting lutein and zeaxanthin for beta-carotene avoids concerns of lung cancer in current and former smokers

      - “AREDS2 found no increased risk of lung cancer
         with lutein/zeaxanthin supplementation” 1

No clinically or statistically significant differences in serious adverse events (AEs) was seen between the 80-mg and 25-mg zinc groups


AREDS2 highlights

The AREDS2 study researchers concluded that lutein and zeaxanthin were preferable substitutes for beta-carotene, especially for current or former smokers.

Lutein and zeaxanthin 1

  • Adding lutein and zeaxanthin to the original AREDS formula did not further reduce the risk of progression to AMD in the primary analysis

  • Benefit vs. beta-carotene seen in secondary analysis

  • No increased risk of lung cancer

Zinc 1

  • Researchers continue to support the 80-mg level of zinc as previously recommended in the original AREDS formula

  • Treatment main effect favored 80 mg zinc vs. 25 mg zinc, although difference was not statistically significant

  • No differences were seen in adverse events between 80 and 25 mg levels of zinc

  • AREDS2 did not test for equivalency between 80- and 25-mg levels

  • 80 mg only level proven to reduce risk of AMD progression compared to placebo in the 2001 AREDS trial

Beta-carotene 1

  • Increased risk of lung cancer in former smokers taking beta-carotene (2.0%) vs. no beta-carotene (0.9%)

  • Removing beta-carotene from the formula did not impact risk of progression to advanced AMD

Omega-3 fatty acids 1

  • No benefit or harm was seen by adding omega-3 fatty acids to the original AREDS formula


† The primary endpoint was powered to detect a 25% reduction compared to AREDS variants.
‡ The lutein/zeaxanthin group included “never,” current, and former smokers.


*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

References

1. Age-related Eye Disease Study 2 Research Group. Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. JAMA. 2013;309(19)2005-2015.