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9/7/11 Introduction 01+$2,!-3#45$#(6!"$3)7%$89!:/! /;;4*+9#$!<(42$;;4(,!"00-! • With no effective means of prevention, the prevalence of ARMD will only increase as the population ages • For these reasons, identification of inexpensive, safe strategies to prevent ARMD is paramount • Optometry should be at the forefront of this! AREDS: The Age Related Eye Disease Study AREDS Nutritional Options for AMD ! "#$%$&!'$(()**+,!-.,!'//-! • Objective: To evaluate the effect of high-dose vitamins C and E, beta carotene, and zinc supplements on AMD progression and visual acuity ! 11 center, double-masked study ! 3640 participants, age 55-80 ! Average follow-up of 6.3 years • Patients divided into 4 categories based on level of ARMD – Category 1: early ARMD – Less than 5 small drusen (<63um) – Category 2: mild ARMD – Multiple small drusen – Single intermediate size druse (63-124 um) – Category 3: moderate ARMD – One large druse (125 um) – Extensive intermediate drusen – GA not centrally – Category 4: advanced ARMD – More than one large drusen – GA centrally AREDS: Results • 25% decrease risk reduction in developing advanced ARMD in categories 3 and 4 with antioxidants plus zinc – – – – – 500 mg vitamin C 400 IU vitamin E 15 mg vitamin A (25,000 IU beta carotene) 80 mg zinc 2 mg copper • Due to low progression to advanced ARMD in categories 1 and 2, unable to show benefit • No statistically significant effect on cataracts AREDS: Shortfalls • No apparent benefit in category 1 and 2 – 80% fall into this group • Unsure how long someone at risk should continue supplements • Beta carotene associated with increased risk of lung cancer in smokers – substitution of other antioxidants (lutein) is unclear – how long a non-smoker is debatable 1 9/7/11 AREDS: Shortfalls • Did not evaluate the role of lutein/zeaxanthin, or omega 3 s – AREDS 2 underway, but may be several years till results are in • Benefit is modest, and all groups had progression despite treatment • The supplements are not a cure for ARMD, nor will they restore vision already lost from the disease AREDS: Take home • Reasonable to suggest antioxidant plus zinc in patients with moderate to severe ARMD • No proven benefit in early to mild ARMD • Increased risk of lung cancer with beta carotene should be considered in smokers and past smokers – AREDS press release 10/2001 Lutein and Zeaxanthin • Naturally occurring carotenoids that are found in high concentration in the eye, specifically the macula/retina • Many feel protective for ARMD – Absorbing blue light – Quenching free radicals – Increasing membrane stability Lutein and Zeaxanthin • Several smaller studies have shown positive benefit of Lutein and/or Zeaxathanin – Seddon Study, 1994: Evaluated dietary carotenoids, vitamins A, C and E • 356 pts • Pts with highest dietary intake of carotenoids (specifically lutein and zeaxanthin) had a 43% lower risk for ARMD than those with lowest levels – LAST Study: Stuart Richer, Optometry, April 2004 • 90 pts, mostly male • Increased MPOD, increase VA, glare recovery, contrast sensitivity in pts taking L and L plus antioxidnants vs. placebo – LUXEA Study: 2006 • 92 pts taking L, Z, C, or P • Small (13%) in MPOD among pts taking L Lutein and Zeaxanthin Meso-zeaxanthin • Cumulative effect of studies seem to indicate a positive effect of Lutein as well as Zeaxanthin on MPOD and ARMD • No single, large scale study like AREDS yet done • MZ is the dominant carotenoid in the central fovea • Of the three macular carotenoids, MZ is the most powerful antioxidant • MZ facilitates a wider range of blue light filtration • Ideally located to afford protection against free radical damage – Will be evaluated in AREDS 2 • Dosage: 10 mg Lutein, 4 mg Zeaxanthin 2 9/7/11 Fish Consumption and Omega-3 Fatty Acids • Conflicting studies in the literature Fish Consumption and Omega-3 Fatty Acids • Conflicting studies in the literature – Seddon et al, Ophth 2004: 60% reduced risk to advanced ARMD for people who w/ highest fish consumption (> 2 times /wk) – Ophthalmology, July 2006: issue of protective nature neither clearly supported nor refuted – Arch Ophthalmology, July 2006: US Twin study showed that fish consumption and omega-3 fatty acids intake reduced the risk of ARMD – Arch Ophthalmology, July 2006: a diet high in omega 3 fatty acids , especially from fish, suggests protection against early and late in Australian patients – AREDS Report No. 20: 40-50% reduced likelihood of advanced neovascular ARMD in pts with highest levels of omega-3 consumption – AREDS Report No. 23: 50% decreased likelihood of progression to central GA with highest level of omega 3/FA consumption – The American Journal of Clinical Nutrition, August 2008: eating oily fish at least once per week reduced risk of neovascular ARMD by half Fish Consumption and Omega-3 Fatty Acids • Bottom line: unclear, however omega 3 and DHA/EPA do seem protective – 1000 mg/day – At least 2/3 DHA and EPA • Need to await results of AREDS 2 to know for sure (hopefully) • Suggest oily fish and least once per week? – Salmon, trout, sardines, mackerel, herring, anchovies, swordfish, fresh tuna B&L PreserVision™ • OTC formulation by B&L • Several Formulations: – Original, soft gel ,and Lutein Other vitamins • Co-Q 10 – A coenzyme produced by the body and required for basic function of all cells – Used in neurology – Studies are inconclusive • Lycopene – Another carotenoid found in red fruit and vegetables such as tomatoes, guava, watermelon, pink grapefruit and papaya – Helpful for prostate issues in men – Unknown effect in ARMD • Taurine – Some studies indicate that due to its high concentration in the eye, may play a protective role in ARMD – In cats, taurine deficiency has been shown o cause retinal degeneration – Speculative only at this point • Acetyl-l-carnitine – Many have anti-oxidant as well as anti-aging properties – Role in ARMD unknown B&L AREDS 2 Formula • Based on Original AREDS formula plus new evidence – No Beta-carotene – 1000 mg omega 3 • 350 DHA, 650 EPA – 10 mg Lutein – 2 mg zeaxanthin • 2 soft gels BID 3 9/7/11 B&L AREDS 2 Formula ICAPS® • Developed and marketed by Alcon • Three formulations: AREDS, Lutein & Zeaxanthin, and MV – Now in soft-gel as well AREDS Multivitamin Compositions Theoretical AREDS1 ICAPS® AREDS (Labeled Amount) (Actual Amount) 2 tablets, twice daily 2 tablets, twice daily 1 tablet, once daily 2 tablets, twice daily Daily Dosage Daily Dosage Daily Dosage Daily Dosage 15 mg (25,000 IU) 17.2 mg (28,640 IU) 2.1 mg (3,500 IU) (29% as Beta Carotene) ! Vitamin C 500 mg 452 mg 60 mg 512 mg Vitamin E 400 IU 400 IU 45 IU 430 IU Zinc 80 mg 69.6 mg 15 mg 84.6 mg Copper 2 mg 1.6 mg 2 mg Lutein - ! 250 mcg Ingredient Centrum Silver* ICAPS® Ocular Vitamins ICAPS® MV* (Actual Amount) Lutein & Zeaxanthin Formula 1 tablet, twice daily Daily Dosage Vitamin A (Beta-Carotene) Zeaxanthin Omega-3 s ! ! ! ! Vitamin A (beta-carotene) 6,600 IU Vitamin C 400 mg Vitamin E 150 IU Zinc 60 mg Copper 4 mg Lutein/Zeaxanthin (combined) 4 mg (4,000 mcg) 3.6 mg Riboflavin (Vitamin B2) 10 mg 6.7 mg Calcium 30 mg Selenium 40 mcg Manganese 10 mg 3.3 mg ! ! • Best for pre-ARMD patients * Both Centrum and ICaps® MV contain other less important ingredients at the RDA s. ICAPS® Ocular Vitamins ICAPS® MV Multi-Vitamin 2 tablets, twice daily Daily Dosage Vitamin A (Betacarotene) AREDS Formula AREDS Formula 2 tablets, twice daily 1 softgel, twice daily Daily Dosage Daily Dosage 28,640 IU (100% as Beta Carotene) Vitamin A (beta-carotene) Folic Acid 400 mcg Vitamin C 512 mg - Vitamin B12 6 mcg Vitamin E 430 IU Biotin 30 mcg 28,640 IU (100% as Beta Carotene) Lutein 6.67 mg Pantothenic Acid 10 mg Zinc 84.6 mg Calcium** 300 mg 3.6 mg Phosphorus 140 mg Vitamin C 452 mg 452 mg Copper Vitamin E 400 IU 400 IU Zeaxanthin 3.33 mg Iodine 150 mcg Zinc 69.6 mg 69.6 mg Vitamin D 400 IU Magnesium 100 mg Copper 1.6 mg 1.6 mg Vitamin K 25 mcg Selenium 40 mcg Thiamin 1.5 mg Manganese 2 mg Riboflavin (Vitamin B2) 10 mg Chromium 120 mcg Niacin 10 mg Molybdenum 75 mcg Vitamin B6 2 mg Lycopene 0.3 mg Calcium 132 mg Best for ARMD stage 3,4 • Best for smokers or pts who want only 1 vitamin 4 9/7/11 New ICAPS® Lutein and Omega-3 ICAPS® Lutein & Omega Active Ingredients • Ideal Combination of Ingredients for General Eye Health and patients at risk of AMD: Actives Vitamin A (beta-carotene) Vitamin A (retinol) Vitamin C Vitamin E Vitamin B1 (Thiamin) Vitamin B2 (Riboflavin) Vitamin B3 (Niacin) Vitamin B6 Vitamin B9 (Folic Acid) Vitamin B12 (Cyanocobalamin) Zinc Selenium Copper Manganese Lutein (Zeaxanthin) Zeaxanthin Omega -3 Fatty Acids • One Softgel Daily – 10 mg of Lutein – 2 mg of Zeaxanthin – 280 mg Omega-3 – B Vitamins – No Beta-carotene • Best for early, or at risk pts • One per day!! ICaps® Lutein & Omega 1 Per Day Daily Dosage ICaps® Lutein & Omega % RDA Daily Dosage 600 mcg 45 mg 10 mg 1.2 mg 1.3 mg 16 mg 1.3 mg 240 mcg 2.4 mcg 7 mg 34 mcg 0.9 mg 2.3 mg 10 mg 2 mg 280 mg 20% 75% 50% 80% 76% 80% 65% 60% 40% 47% 49% 45% 115% * * * *Percent Daily Value not Established Maxivision LMZ3 by MacuHealth 452mg C 400IU E 69.6mgZ • 1 capsule daily with a meal – 10 mg Lutein – 10 mg Meso-zeaxanthin – 2 mg zeaxanthin 1.6mg Cu • Doctor driven and sold • Claims to have highest level of lutein $20/60 pills Dr. Bob Martin s OptiAll Premier Formula for Ocular Nutrition 28,640IU A 452mg C • 400IU E • 69.6mgZ • • 1.6mg Cu • • • • • • Close to AREDS • Expensive: $90/200pills • – 50 day supply • Adds Taurine and Lutein • Carnosine reduces the risk of cross-linking (the process in which protein and glucose starts sticking together) which increases the risk of eye degeneration.* Astaxanthin is 100 times more effective at inhibiting lipid peroxidation than is Vitamin E.* Other tests have shown that Astaxanthin is up to 1000 times more powerful than Vitamin E.* A recent study shows that Astaxanthin is effective at protecting the retinal, and that it is also effective at protecting photoreceptors,* and easily crosses the blood-brain barrier (unlike Beta-Carotene). Vitamins C, E, A, Beta Carotene, Zinc and Selenium significantly cuts the risk of vision and eye concerns, says a recent groundbreaking study. Lutein and Zeaxanthin protect the macula region of the eye (the area responsible for detailed vision) from free radical damage and retard age-related eye concerns.* Rutin and Quercetin are excellent antioxidants utilized in the body to enhance the effectiveness of Vitamin C, and help strengthen the walls of the intricate blood vessels in the eye.* Taurine is an amino acid that is important for the maintenance of healthy tissues of the retina. It helps protect the eyes from harmful effects of ultraviolet light.* N-Acetylcystein (NAC) is a major glutathione precursor. Glutathione has antioxidant activity which may promote healthy eyes, and is crucial in protecting against free radical damage.* Alpha Lipoic Acid (ALA) is a vitamin-like antioxidant that supports good vision and eye health by its antioxidant protection and its ability to regenerate and increase Vitamins C and E in the body.* Gingko is a powerful herbal extract that may increase the circulation of blood to the eyes, and has shown to help lower intraocular pressure in the eyes. It has antioxidant activity, improves arterial blood flow and enhances cellular metabolism.* Bilberry has antioxidant and anti-inflammatory effects, and strengthens the structural integrity of blood vessels throughout the body and promotes healthy circulation, particularly to the small capillaries that deliver oxygen and nutrients to the eyes.* Bilberry also helps prevent free radical damage to the delicate structures within the eye, and may help your night vision and adaptation to the dark, and promote visual acuity and capillary integrity.* Other Beneficial Natural Ingredients: Rutin, Eyebright, Green Tea Extract, Vitamins B-2 and B-6. 2 tablets/BID 5 9/7/11 Ocular Lutein Formula Spray Dose: 6 sprays per day for the first two months then 3 sprays per day for the next two months and lastly 1 spray per day as a preventative Form: Spray Pack size: Availability: Each bottle contains 30ml (approximately 180 sprays) Ordered as required - usually dispatched within 1 week 6 sprays (approx 1ml) of Ocular Spray provides the following: Vitamin B3-Niacin 5.0mg Vitamin E 4IU Lutein 1.25mg Coleus Forskohlii 6.25mg Tylophora Asthmatica 6.25mg Zeaxanthin 0.1mg Gingko Biloba Are People using AREDS Supplementation? 69.84% AREDS 11.83% 4.64% Other Lutein Alone 0.93% 0.00% 20.00% • Several reports indicate that patients are not taking vitamins – 42% (13/31) of patients eligible for supplementation were taking it properly if at all – these were patients who had it recommended and discussed with doctor and staff – Australian study: 58% of eligible ARMD patients had heard of vitamins, 38% were taking, but only 1% taking correctly 12.76% C, E, Zinc & Lutein • Is AREDS supplementation standard of care? • YES!!! • 2009 study of American Society of Retina Specialists revealed almost 70% of Retina Specialists recommend AREDS supplementation for AMD patients with high risk non-exudative disease 1mg Retinal Specialist Vitamin Recommendations C, E, Zinc, Lutein & Zeaxanthin Question? 40.00% 60.00% 80.00% • Why ? American Society of Retina Specialists, Preference and Trends Survey 2009 434 Retina Specialists – What vitamin regimen for AMD patients with high risk non exudative disease do you recommend? Are People using AREDS Supplementation? • Confusion: – At least 400 products for the eye • About 50 4-5 yrs ago – many different brands that may or may not have correct dosages • Cost – $20/30 day supply – $240/year • Not all providers are advocates of AREDS supplementation Cost effectiveness of Vitamin Therapy • July 2007, Ophthalmology • Computer based model • Concluded that improves quality of life in ARMD patients at a reasonable cost • Also stated should be a high public health preventive measure – As high as breast cancer screening in woman >50 and vision screening in children to detect strabismus and amblyopia at 85% compliance 6 9/7/11 AREDS 2 • AREDS 2: Enrollment ended June 2008 with patients to be followed for six years – Effect of lutein, zeaxanthin and omega 3 on ARMD – Effect of eliminating beta carotene on ARMD – Effect of reducing zinc on ARMD – Effect of supplements on cataracts – Validate the ARMD scale from original AREDS • Results may not be available for 3-4 more years Vitamins: Take Home Vitamins: Take Home • Use AREDS formulation in suitable patients • Encourage proper dosing • Discourage use of similar products that differ from AREDS formulation – Recommend what you want patient to take! • Review literature to determine value of other supplements, especially lutein, zeaxanthin, and omega-3 s Conclusion • The best intake is through diet/food – Not always realistic: – Average American gets only 2mg Lutein – Leading antioxidants for average American is coffee – French fries account for 25% of all vegetable intake in US – Vitamin E 13x, A and C 5x recommended daily dose – Only 3% of Americans follow 4 basic health practices No smoking BMI 18.5 – 25 5 or more FRUITS & VEGATABLES daily > 30 minutes physical activity/ 5x times wk • Discuss AREDS with all ARMD patients • Take AREDS formulation unless contraindicated in stage 3,4 • Tell patients which product you recommend and WHY!!! • Discuss pros/cons in other pts with ARMD but not 3,4 • Discuss prevention in high risk patients – Consider lutein, omega 3 s in these patients 7