115660_vitalux_detailaid.qxd 21/04/04 15:56 Side 1 Vitalux the effective way to delay the progression of AMD FPO THE FULL RANGE OF EYE TREATMENTS RETINA GLAUCOMA ALLERGY DRY EYE INFLAMMATION
115660_vitalux_detailaid.qxd 21/04/04 15:56 Side 2 The retinal oxidative stress cascade Triggers * Free radicals What is oxidative stress? Free radicals initiate local molecular instability leading to cellular damage. Formation of free radicals is caused by: metabolism, sunlight (blue light spectrum), other free radicals, lack of antioxidants and other factors. Oxidative stress AMD/Diabetic Retinopathy 2 Visual deterioration * Age, Smoking, Poor diet, Excessive light exposure, Systemic diseases, Hereditary predisposition The retina is particularly vulnerable to oxidative stress. Contributing factors include 1 high consumption of oxygen a diet high in polyunsaturated fatty acids cumulative exposure to irradiation 1. Beatty et al. The Role of Oxidative Stress in the Pathogenesis of Age-Related Macular Degeneration. Surv Opthalmol 2000; 45:115-34.
115660_vitalux_detailaid.qxd 21/04/04 15:56 Side 3 Nutrients blocking the oxidative stress cascade Antioxidant supplementation Certain nutrients counteract the chain reaction of free radical damage by neutralizing the electron imbalance, thus acting as an antioxidant. 3 * Age, Smoking, Poor diet, Excessive light exposure, Systemic diseases, Hereditary predisposition Replenishing the antioxidant potential of the retina may effectively 1 decrease oxidant stress slow or decrease retinal deterioration 1. Seddon et al. Dietary Carotenoids, Vitamins A. C, and E, and Advanced Age-Related Macular Degeneration. JAMA 1994; 272:1413-20.
115660_vitalux_detailaid.qxd 21/04/04 15:56 Side 4 Nutritional supplementation and retinal oxidative stress Free radical exposure and retinal disease development hypothesis 1 oxidant Ratio: antioxidant Increased exposure to oxidants (e.g. through smoking) Normal AMD threshold Decreased exposure to oxidants (e.g. through healthy diet) 4 Age Oxidative stress may increase susceptibility to disease. Appropriate intervention may 2 delay disease onset protect against further damage 1. Adapted from Cai et al. Oxidative Damage and Protection of the RPE. Progress in Retinal and Eye Research 2000; 19(2): 205-21. 2. Seddon et al. Dietary Carotenoids, Vitamins A. C, and E, and Advanced Age-Related Macular Degeneration. JAMA 1994; 272:1413-20.
115660_vitalux_detailaid.qxd 21/04/04 15:57 Side 5 Lutein supplementation the potential to intervene on AMD pathology Blue Light Exposure to visible blue light has been linked to the development of AMD 1,2 Average levels of lutein and zeaxanthin in AMD patients were found to be 32% lower than in controls 3 Visible blue light has been shown to be damaging to photoreceptors and the RPE 4 Lutein and zeaxanthin have been shown to absorb blue light 5,6 NORMAL EYE Lutein AMD EYE AMD EYE 5 AMD patients who began taking lutein supplements regularly after initial diagnosis, returned their macular pigment levels to the normal range 3 A simplified illustration of AMD pathogenesis and the role of lutein Retinal pigment epithelium (RPE) Carotenoid intake has shown to reduce the risk of severe AMD thus demonstrating a clear link between dietary supplementation and disease management 7 1. Taylor HR, et al. The Long-term Effects of Visible Blue Light on the Eye. Arch Ophthalmol 1992;110:99-104 2. Cruickshanks KJ, et al. Sunlight and age-related macular degeneration. The Beaver Dam Eye Study. Arch Opthalmol 1993;111:514-518. 3. Bernstein PS, et al. Resonance Raman Measurement of Macular Carotenoids in Normal Subjects and in Age-related Macular Degeneration Patients. Ophthalmology 2002;109(10):1780-1787 4. Pratt SG. What We Now Know About AMD and Nutrition. Review of Ophthalmology 1998;08. (www.revophth.com) 5. Snodderly DM. Evidence for protection against age-related macular degeneration by carotenoids and antioxidant vitamins. Am J Clin Nutr 1995;62(suppl):1448S-1461S 6. Landrum JR, et al. A One Year Study of the Macular Pigment: The Effect of 140 Days of a Lutein Supplement. Exp. Eye Res. 1997;65:57-7. Seddon et al. Dietary Carotenoids, Vitamins A. C, and E, and Advanced Age-Related Macular Degeneration. JAMA 1994; 272:1413-20.
115660_vitalux_detailaid.qxd 21/04/04 15:57 Side 6 Lutein supplements proven efficacy in oxidative stress Lutein intake reduces the risk of AMD 1 1.2 1.1 (0.7, 1.8)* 1.0 Risk of AMD 0.9 0.8 0.7 (0.5, 1.3)* (0.5, 1.2)* 0.6 ** 0.5 0.4 (0.2, 0.7)* 1000 2000 3000 4000 5000 6000 Lutein intake (µg/day) *95% CI, p<0.001 6 Vitalux contained lutein dose ** Arbitrary risk reduction Macular pigment loss constitutes a major risk factor in the development of AMD. Lutein may delay or alter the course of the disease by replenishing this loss 2 1. Seddon et al. Dietary Carotenoids, Vitamins A. C, and E, and Advanced Age-Related Macular Degeneration. JAMA 1994; 272:1413-20. 2. Beatty et al. Macular Pigment and Risk for Age-Related Macular Degeneration in Subjects from a Northern European Population. Invest Ophthalmol Vis Sci 2001;42:439-46.
115660_vitalux_detailaid.qxd 21/04/04 15:57 Side 7 AREDS (The Age-Related Eye Disease Study) Study design 1 Randomized, double-blind, placebo-controlled study with 3640 subjects enrolled. Subjects had AMD and were categorized into four groups according to disease severity. Subjects were randomized to receive either antioxidants (Vit C 500 mg, Vit E 400 IU, and Beta Carotene 15 mg), zinc and copper (80 mg and 2 mg respectively), antioxidants plus zinc and copper, or placebo. Average follow-up was 6.3 years. 7 The AREDS treatment showed a beneficial effect in delaying the progression of intermediate AMD* to advanced AMD**. AREDS formula Beta Carotene Vitamin C Vitamin E Zinc Copper 1. Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene. And zinc for age related macular degeneration and vision loss: AREDS report No. 8. Arch Ophthalmol 2001; 119: 1417-36. * Defined as large drusen > 125 µm or noncentral geographic atrophy ** Defined as the development of neovascular disease, often referred to as wet AMD or geographic atrophy, often referred to as dry AMD.
115660_vitalux_detailaid.qxd 21/04/04 15:57 Side 8 AREDS supplements proven efficacy in AMD Reduced risk of progression of intermediate AMD to advanced AMD Reduced risk of visual acuity loss ARED study findings and AMD 1 30 Relative change in risk from baseline (percent) 25 20 15 10 5 0 Antioxidants Zinc Antioxidants + Zinc Reduced risk of progression to advanced AMD Reduced risk of visual acuity loss 8 The progression of AMD * can be reduced by daily administration of Zinc and Antioxidants as demonstrated in the ARED study 1 1. Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene. And zinc for age related macular degeneration and vision loss: AREDS report No. 8. Arch Ophthalmol 2001; 119: 1417-36. * Patients with at least intermediate drusen in one eye.
115660_vitalux_detailaid.qxd 21/04/04 15:57 Side 9 Beta carotene and smokers The CARET (The Beta-Carotene and Retinol Efficacy Trial) study 1 : Randomized, double-blind, placebo-controlled study with 18314 subjects* Subjects were high-risk lung cancer patients with an average of 49 pack-years of cigarette smoking Subjects were randomized to receive either 30 mg beta carotene and 25000 IU retinyl palmitate or placebo, and were followed for 5 or 10 years 9 The CARET study was terminated 21 months early due to safety concerns Results yielded a 23% higher incidence of lung cancer among smokers receiving beta carotene and Vitamin A than patients receiving placebo. Patients should be discouraged from ß-carotene intake if they are 1 current smokers asbestos-exposed workers 1. Omenn et al. Risk Factors for Lung Cancer and for Intervention Effects in CARET, the Beta-Carotene and Retinol Efficacy Trial. J Natl Cancer Inst 1996; 88: 1550-9. * Out of the 18314 subjects, 14000 were smokers (4000 of the subjects suffered from asbestos exposure)
115660_vitalux_detailaid.qxd 21/04/04 15:57 Side 10 Nutritional supplements have a beneficial effect on the development of advanced AMD Potential reduction in the progression of AMD 1 10 Over a 5 year period, AREDS supplementation could prevent 300.000 at risk patients from 1 progressing to advanced AMD experiencing associated visual deterioration 1. Age-Related Eye Disease Study Research Group. Potential Public Health impact of Age-Related Eye Disease Study Results. AREDS Report No. 11. Arch Ophthalmol 2003; 121: 1621-1624. * Based on 59 million people over the age of 55 (USA, 2000)
115660_vitalux_detailaid.qxd 21/04/04 15:57 Side 11 A powerful combination of retinal antioxidants AREDS components with extra lutein AREDS components without Beta Carotene Vitalux Plus Vitalux S FPO FPO 11 Content Beta Carotene, Vitamin C, Vitamin E, Zinc, Copper, Lutein Dosing 1 tablet/day or as directed Content Vitamin C, Vitamin E, Zinc, Copper, Lutein Dosing 1 tablet/day or as directed Vitalux provides a full range of antioxidant nutritional supplements aimed at treating retinal diseases.
115660_vitalux_detailaid.qxd 21/04/04 15:57 Side 12 Vitalux Plus AREDS components with extra lutein FPO 12 Content Beta Carotene, Vitamin C, Vitamin E, Zinc, Copper, Lutein Dosing 1 tablet/day or as directed AREDS nutrients and lutein showed benefits in delaying the progression of AMD. Vitalux Plus contains both AREDS nutrients and lutein.
115660_vitalux_detailaid.qxd 21/04/04 15:57 Side 13 Vitalux S AREDS components without Beta Carotene FPO 13 Content Vitamin C, Vitamin E, Zinc, Copper, Lutein Dosing 1 tablet/day or as directed Vitalux S is the obvious choice for smokers who want to reduce their risk of retinal disease progression.
115660_vitalux_detailaid.qxd 21/04/04 15:57 Side 14 Vitalux and AREDS components a head-to-head comparison Vitalux scientifically formulated AREDS (study supplement total daily dosage) Vitalux Plus (per tablet) Vitalux - S (per tablet) ICAPS Lutein (per tablet) OCUVITE Plus with Lutein (per tablet) OCUVITE Lutein (per tablet) Beta Carotene (provitamin A) 25.000 IU (15 mg) 10.000 IU 3.300 IU 10.000 IU Vitamin C 500 mg 300 mg 250 mg 200 mg 200 mg 60 mg Vitamin E Vitamin B2 (riboflavin) 400 IU 100 IU 20 mg 200 IU 75 IU 5 mg 60 IU 30 IU Selenium 50 mcg 20 mcg 55 mcg Manganese 5 mg Zinc Copper 80 mg 2 mg 40 mg 2 mg 40 mg 1 mg 25 mg 2 mg 40 mg 2 mg 15 mg 2 mg 14 Lutein 4 mg 3 mg 2 mg 2 mg 6 mg Label Dosage 1 tab/day or as directed 1 tab/day or as directed 2 tab/day or as directed 1 tab/day or as directed 1 tab/day or as directed Vitalux the only supplement that provides all of the nutritients in the AREDS formulation, plus extra lutein.
115660_vitalux_detailaid.qxd 21/04/04 15:57 Side 15 Novartis Ophthalmics committed to fighting retinal disease Prevention of retinal diseases Treatment of retinal diseases Risk factors: Age 1 Smoking 2 Poor diet 3 Excessive light exposure Systemic diseases 4 Hereditary predisposition 5 Preventative measures 6 Antioxidants in nutritional supplements Diagnosed AMD 7 Antioxidants in nutritional supplements Diagnosed AMD 8 Visudyne Diagnosed Diabetic retinopathy 9 Antioxidants in nutritional supplements 15 Novartis Ophthalmics is a global leader in discovering, developing and delivering innovative medications that preserve and improve vision. 1. VanNewkirk MR et al. The prevalence of age related maculopathy: the visual impairment project. Ophthalmology 2000; 107:1593-1600. 2. Christen WG et al: A prospective study of cigarette smoking and risk of age related macular degeneration in men. JAMA 1996 Oct 9;276 (14):1147-1451. 3. Seddon et al. Dietary Carotenoids, Vitamins A. C, and E, and Advanced Age-Related Macular Degeneration. JAMA 1994; 272:1413-20. 4. Age Related Eye Disease Study Research Group. Risk Factors Associated with Age Related Macular Degeneration. A Case Control Study in Age Related Eye Disease Study:Age Related Eye Disease Study Report Number 3. Ophthalmology 2000; 107:2224-2232. 5. Hammond EL et al. Genetic Influence on Early Age-related Maculopathy. A Twin study. Ophthalmology 2002;109:730-736. 6. Seddon et al. Dietary Carotenoids, Vitamins A. C, and E, and Advanced Age-Related Macular Degeneration. JAMA 1994; 272:1413-20. and Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene. And zinc for age related macular degeneration and vision loss: AREDS report No. 8. Arch Ophthalmol 2001; 119: 1417-36. 7. Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene. And zinc for age related macular degeneration and vision loss: AREDS report No. 8. Arch Ophthalmol 2001; 119: 1417-36. 8. Treatment of Age related Macular Degeneration with Photodynamic Therapy (TAP Study Group. Photodynamic Therapy of Subfoveal Choroidal Neovascularization in Age related Macular Degeneraton With Verteporfin: One-Year Results of 2 Randomized clinical Trials: TAP Report 1. Arch Ophthalmol 1999;117:1329-1345. 9. Schönlau F and Rohdewald P. Pycnogel for diabetic retinopathy. Int Ophthalmol 2002;24:161-171.
115660_vitalux_detailaid.qxd 21/04/04 15:57 Side 16 Vitalux nutritional supplements help prevent a range of retinal diseases Beneficial in AMD and diabetic retinopathy 16 An integral part of the Novartis Ophthalmics commitment to treating retinal conditions Convenient and easy to use Nutrition, Eye protection, Convenient and From the experts are the four cornerstones of.