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Beyond AREDS: The TOZAL Study and AREDSII

Beyond AREDS: The TOZAL Study and AREDSII. Edward Paul, OD, PhD. Financial Disclosure . The author is the developer and patent holder of TOZAL Eye Health Formula The author is a member of the Scientific Advisory Board of AmeriSciences , Houston, Texas.

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Beyond AREDS: The TOZAL Study and AREDSII

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  1. Beyond AREDS: The TOZAL Study and AREDSII Edward Paul, OD, PhD

  2. Financial Disclosure • The author is the developer and patent holder of TOZAL Eye Health Formula • The author is a member of the Scientific Advisory Board of AmeriSciences, Houston, Texas

  3. Has The Fringe Become The Cutting Edge? • JAMA – June 2002 • “Adults should take at least one multivitamin each day … 80% of Americans are not consuming sufficient nutrients. Vitamins appear to be able to prevent chronic illnesses such as heart disease, cancer, and osteoporosis.” • Fletcher & Fairfield / Harvard Medical School

  4. Why Everyone Should Take A Multivitamin • We eat the same 8-10 foods every week • All human disease is believed to have some relationship to free radicals, oxidation, and inflammation • Smoking, Alcohol, Lack of Exercise, Stress, and Poor Diet increase free radicals, inflammation and promote chronic, degenerative disease

  5. Main Stream Medicine is Waking Up to Nutritional Medicine • 50% of Americans take nutritional supplements – spending $500 billion annually • 79% of physicians recommend nutritional supplements to their patients

  6. Nutrition Has Become The Standard of Care in Medical Management • Folic Acid prevents neural tube birth defects – given to mothers during pregnancy • Calcium and Vitamin D prevents and may reverse Osteoporosis • Magnesium reduces heart spasm • Vitamin B12 is routinely given to geriatric patients to reduce fatigue • Fiber helps control glucose levels and improves digestion

  7. The Disease State Can Be Altered We can modify the NUTRITIONAL and ENVIRONMENTAL states of our patients In the near future we will be able to modify GENETICS

  8. AMD(Age-Related Macular Degeneration) • 15 million+ Americans are affected by AMD • 14% of patients over 55 • 25% of patients over 65 • 37% of patients over 75 • 50 million+ Americans are at risk for AMD • In the US alone, these numbers will increase by over 50% by 2020 – the global picture is similar

  9. The Objectives • To study xanthophylls (lutein & zeaxanthin) and omega-3 fatty acids on the development of advanced AMD • To study the effects of these supplement on cataract and moderate vision loss • To study the effects of eliminating beta-carotene from the original AREDS formula • To study the effects of reducing zinc in the original AREDS formula

  10. Study Design for AREDS2 • 4,000 patients / 5 year study / ~100 clinical sites • Results expected to be published in 2012 • Participants aged 50 to 85 with large drusen and/or advanced AMD • All participants will be given one of 4 variations of the original AREDS formula: • AREDS formula • AREDS formula with no beta-carotene • AREDS formula with lower amounts of zinc • AREDS formula with no beta-carotene and lower amounts of zinc

  11. Study Design for AREDS2 • In addition to one of the variations the AREDS formula (4), patients will be given one of 4 randomized supplements: • 10 mg. lutein / 2 mg. zeaxanthin • 1,000 mg. O-3 (omega-3 fatty acids) • 10 mg. lutein / 2 mg. zeaxanthin / 1,000 mg. O-3 • Placebo • 16 arms to this study

  12. www.TOZAL.info Patients: 37 Treated 15 Placebo-Cohort Mean Age: 76.6 years 5 Independent U.S. Study Sites 4 University Medical Centers 1 Private Ophthalmologist (Retina) Patients Followed for 6 Months Treated Patients Gained An Average of 0.5 lines Placebo Patients Lost An Average of 1.5 lines Net Gain of 2.0 lines TOZAL Study (Taurine / Omega-3 / Zinc / Antioxidants / Lutein)

  13. TOZAL Clinical Results76.7% Improved or Stabilized • 56.7% Experienced Improved Vision • 20% Experienced Stable Vision • 23.3% Continued To Worsen (Natural Disease Progression: No Worse Than Placebo)

  14. TOZAL 76.7% Improved or Stablized 23.3% Continued to Worsen – Natural Disease Progression AREDS 0% Improved or Stablized 25% Had a “Reduction in Risk” of Vision Loss 75% Continued to Worsen – Natural Disease Progression TOZAL v. AREDS

  15. TOZAL v. AREDSII • AREDSII = OZAL (TOZAL without Taurine)

  16. PreserVision® ICaps® TOZAL®

  17. A Paradigm Shift • Every patient with AMD or at risk for AMD should take an AMD targeted nutritional supplement • Risk Factors • Aging (55 + years of age) • Family History • Caucasians / Asians • Female Gender • Smoking (increases AMD by 350%) • Cardiovascular Disease / Hypertension / Hyperlipidemia

  18. Third-Party Endorsements for the use of vitamins as a PREVENTIVE for AMD • National Institutes of Healthfound that individuals who had the highest consumption of lutein and zeaxanthin had a 43% lower risk of developing AMD • Archives of Ophthalmology reported a 70% reduction in developing AMD with the consumption of 3 servings of omega-3 fatty acids each week and a 40% reduction with 1 serving each week. • Massachusetts Eye and Ear Infirmary of Harvard Medical School reported that increased omega-3 fatty acid intake reduced the risk of AMD by 22% • Macular Degeneration Partnership suggests vitamin supplementation for those who: • are over age 50 • have a family history of AMD

  19. Dry Eye Syndrome & Omega Fatty Acids • MOA - Increases the lipid component of the tear film and acts as an anti-inflammatory agent • Fish Oil • Flax Seed Oil • Evening Primrose Oil • Borage Oil • Black Current Seed Oil

  20. Omega Fatty Acids v. DoxycyclineIn the Treatment of Dry Eye • 81 Dry Eye Patients Undergoing LASIK • 3,000 mg Flax Seed Oil v. 200 mg Doxycycline • Treated 7 days before and after LASIK • Flax Seed Oil was as effective as Doxycycline and had fewer side effects • Chan & Wachler / 2006 ACRS Meeting

  21. Retinopathy & Omega-3 Fatty Acids • Increased dietary intake of Omega-3 fatty acids reduces pathological retinal angiogenisis • Conner et al. Nature Medicine. July 2007 • 2% change in dietary Omega-3 intake resulted in a 45-50% decrease in retinopathy severity • We should recommend Omega-3 for diabetics • Clinical Trial is underway to test the effects of Omega-3 supplementation in premature infants at risk of retinopathy

  22. Retinitis PigmentosaHarvard Medical School – Mass Eye & Ear Recommendations • 15,000 IU/day Vitamin A Palmitate • 600 mg DHA (Omega-3) BID (1,200 mg/day) for two years – then d/c supplement and eat 1-2 / 3 oz. servings of Omega-3 fish per wk. • Avoid Vitamin E above 400 IU/day • Other studies show that Lutein may be beneficial?

  23. Stargardt’s Omega-3 Fatty Acids • University of Utah’s Moran Eye Center found elevated dietary intake of Omega-3 fatty acids are inversely associated with severity of disease phenotype in STGD3 patients. • Zhang et.al. found a mutation in the gene, ELOVL4, in individuals with Stargardt-like macular dystrophy. The gene is presumed to function in the pathway of synthesis of very long chain polyunsaturated fatty acids, including DHA. DHA is the major very long chain polyunsaturated fatty acid of the retina. As our North American diet is poor in DHA, we hypothesize that a DHA dietary supplement might improve macular function in individuals with the ELOVL4 mutation. • Two NIH Clinical Trials Underway • 2,000 mg DHA/day

  24. GISII Prevention StudyOmega-3 Fatty Acids • 1 gram serving per day reduced the risk of sudden cardiac death by 45% among people with a prior history of heart attack. • AMERICAN HEART ASSOCIATION recommends at least 2 servings of fish per week or 1 gram of Omega-3s daily for people with coronary heart disease

  25. Antioxidants and the Lens • Vitamin C levels in the lens are 60 times the amount found in the blood • 300 mg of Vitamin C has been shown to significantly reduce Cataracts - Tufts University • Multivitamin supplementation reduced cataracts by 25% in a study involving 17,000 US physicians • Lutein and other phytonutrients may also play a role in preventing and/or slowing the progression of cataracts

  26. Economics of Cataract SurgeryCataract Surgery Is Quick, Painless and Works – Why Try To Prevent or Slow Down The Progression? • 90% of patients over 75 have cataracts • Most commonly performed surgery in the US • 1.5 million cataracts surgeries each year • 650,000 YAG surgeries each year • $8 Billion

  27. If We Could Delay Cataract Surgery By • 10 years - Save 50 % or $4 Billion • 20 years - Save 83% or $6.6 Billion

  28. Contraindications Every Silver Lining Has A Cloud – Jerry Garcia • >400 IU of Vitamin E Should Be Avoided In RP Patients • >400 IU of Vitamin E May Also Increase All Cause Mortality (13%) • Vitamin A – Over 50,000 IU • Liver Damage • Pseudotumor Cerebri • Smokers Should Avoid High Dose “Synthetic” Beta Carotene - May Increase Lung Cancer Risk?

  29. Beyond AREDS Thank You for Viewing This One Hour (1) COPE CE Approved Course

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