Was ist gesichert, was obsolet…
bei Vitaminen und Antioxidantien
PD Dr. med. Tanja Grammer
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• Folsäure und Vitamin B 12
• Vitamin A und Carotenoide
• Omega-3-Fettsäuren
Gliederung
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Frage 1: Wie häufig schätzen Sie, liegt eine subklinische Defizienz von
Vitamin D, Folsäure und Vitamin B12 im Serum bei Menschen
> 65 Jahre in der Allgemeinbevölkerung vor?
1.10%, 10%, 20%
2.30%, 20%, 10%
3.70%, 20%, 30%
4.50%, 10%, 30%
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KORA Studie: Versorgung mit Vitaminen (Serum)
Conzade et al, Prevalence and Predictors of Subclinical Micronutrient Deficiency in German Older Adults:
Results from the Population-Based KORA-Age Study, Nutrients, 2017
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De-Regil LM, Peña-Rosas JP, Fernández-Gaxiola AC, Rayco-Solon P. Effects and safety of periconceptional oral
folate supplementation for preventing birth defects.Cochrane Database of Systematic Reviews 2015, Issue 12.
Art. No.: CD007950. DOI: 10.1002/14651858.CD007950.pub3.
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Vitamin B12
• Cochrane Review 2017:
Homocystein-lowering interventions
for preventing cardiovascular events
• Cochrane Review 2018:
Orale versus i.m. Gabe von Vitamin B12
bei Defizienz (< 200 pg/ml)
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Frage 2: Was trifft für Carotenoide zu?
1. Vitamin A, Alpha- und Betacarotin werden ausschließlich über
pflanzliche Nahrungsmittel aufgenommen.
2. Eine Defizienz von Vitamin A kann zu Nachtblindheit, Xerophthalmie,
Anämie, Hautläsionen oder vermehrten Infektionen führen.
3. Die pflanzlichen Carotenoide Lycopen, Lutein und Zeaxanthin werden
im Organismus zu Vitamin A umgebaut.
4. Carotenoide sind nicht mit kardiovaskulärer Mortalität assoziiert.
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Quellen von Vitamin A and Carotenoiden
Tierische
Nahrungsmittel
• Leber
• Eier
• Butter
• Käse
• Milch
• Fisch
• Fleisch
Pflanzliche Nahrungsmittel
• Spinat
• Salat
• Kürbis
• Curry
• Tomaten
• Mangos
• Papaya
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Lycopen, Lutein, Zeaxanthin
Carotenoide, nicht zu Vitamin A umgewandelt
Tomaten, Spinat, Feldsalat, Broccoli
Antioxidative und photoprotektive Eigenschaften
Schutz vor altersabhängiger Maculadegeneration
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Grammer et al. In preparation
LURIC: Retinol und Gesamtmortalität
Quartile
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Grammer et al. In preparation
LURIC: Carotenoide und Gesamtmortalität
Quartile Quartile
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Grammer et al. In preparation
Lycopene und Lutein/Zeaxanthine und Gesamtmortalität
Quartile Quartile
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NHANES: Vitamin A und Mortalität
• 16,008 Teilnehmer der
• NHANES III (1988–1994) Studie
• 14.2 Jahre follow-up
• Multivariate Adjustierung
Goyal A et al. Cancer Epidemiol Biomarkers
Prev 2013;22:2202-2211
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Bjelakovic et al, Cochrane systematic review 2012
Cochrane Reviews
Keine Evidenz, dass antioxidative Supplemente
Mortalität reduzieren.
Beta-carotene, Vitamin E und Vitamin A
scheinen die Sterblichkeit zu erhöhen.
Antioxidant vitamin and mineral supplements for slowing the
progression of age‐related macular degenerationEvans et al, Cochrane Systematic Review, 2017
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3. Frage: Omega-3-Fettsäuren- Was trifft zu?
1. Omega-3 Fettsäuren pflanzlicher und tierischer Herkunft sind
biologisch gleichwertig.
2. Die regelmäßige Einnahme von Omega-3-Fettsäuren ist mit
verminderter kardiovaskulärer Mortalität assoziiert.
3. Der Omega-3-Index wird im Serum bestimmt.
4. Ein höherer Omega-3-Index ist nicht mit einem niedrigeren Blutdruck
assoziiert.
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Women´s Health Initiative Memory Study
Harris et al, J Clin Lipidol; 2017
>6000 postmenopausale Frauen > 65 Jahre, 15 Jahre Follow-up
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Omega-3- Fettsäuren und Blutdruck
GAPP - Populationsbasierte Kohorte, 2170 Erwachsene (25-41 Jahre)
Filipovic et al, Whole blood omega-3 fatty acid concentrations are inversely associated with blood pressure in young, healthy adults. J Hypetension, 2018
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Omega-3-Fettsäuren und Mortalität- Meta-Analyse
Maki et al, Use of supplemental long-chain omega-3 fatty acids and risk for cardiac death: An updated
meta-analysis and review of research gapsJournal of Clinical Lipidology, 2017
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Cochrane systematic review: Omega-3-Fettsäuren
zur primären und sekundären kardiovaskulären
Prävention
Authors' conclusions
Moderate‐ and high‐quality evidence suggests that increasing EPA and
DHA has little or no effect on mortality or cardiovascular health (evidence
mainly from supplement trials)….
Abdelhamid et al, Omega‐3 fatty acids for the primary and secondary prevention of cardiovascular disease, Cochrane systematic review, 2018
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ASCEND Studie
ASCEND Study Collaborative Group. Effects of n-3 Fatty Acid Supplements in Diabetes Mellitus. N Engl J Med. 2018 Aug 26
15.000 Personen mit Diabetes, 1g EPA+DHA, 7,4 Jahre Follow-up
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REDUCE-IT
Bhatt et al, Rationale and design of REDUCE‐IT:
Reduction of Cardiovascular Events with Icosapent Ethyl–Intervention Trial,
Clin. Cardiol., 2017
REDUCE-IT™ Cardiovascular Outcomes Study of Vascepa® (icosapent ethyl) Capsules Met Primary
EndpointSeptember 24, 2018REDUCE-IT Is First Outcomes Study to Assess Treatment of Patients with LDL-C Controlled by Statin Therapy, Persistent Elevated
Triglycerides and Other Cardiovascular Risk Factors
Results Specific to Pure EPA Vascepa at 4 Grams Daily
Conference Call Scheduled for Today, Monday, September 24, 2018 at 8:00 am ET
BEDMINSTER, N.J. and DUBLIN, Ireland, Sept. 24, 2018 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN), announced today
topline results from the Vascepa® cardiovascular (CV) outcomes trial, REDUCE-IT™, a global study of 8,179 statin-treated adults with elevated CV
risk. REDUCE-IT met its primary endpoint demonstrating an approximately 25% relative risk reduction, to a high degree of statistical significance
(p<0.001), in major adverse CV events (MACE) in the intent-to-treat patient population with use of Vascepa 4 grams/day as compared to placebo.
Patients enrolled in REDUCE-IT had LDL-C between 41-100 mg/dL (median baseline LDL-C 75 mg/dL) controlled by statin therapy and various
cardiovascular risk factors including persistent elevated triglycerides (TGs) between 150-499 mg/dL (median baseline 216 mg/dL) and either
established cardiovascular disease (secondary prevention cohort) or diabetes mellitus and at least one other CV risk factor (primary prevention
cohort).
Key topline results include:
Efficacy: Approximately 25% relative risk reduction, demonstrated to a high degree of statistical significance (p<0.001), in
the primary endpoint composite of the first occurrence of MACE, including cardiovascular death, nonfatal myocardial
infarction (MI), nonfatal stroke, coronary revascularization, or unstable angina requiring hospitalization. This result was
supported by robust demonstrations of efficacy across multiple secondary endpoints.
Safety: Vascepa was well tolerated with a safety profile consistent with clinical experience associated with omega-3 fatty
acids and current FDA-approved labeling. The proportions of patients experiencing adverse events and serious adverse
events in REDUCE-IT were similar between the active and placebo treatment groups. Median follow-up time in
REDUCE-IT was 4.9 years.Amarin is eager to share REDUCE-IT data in greater detail with both the medical community and regulatory authorities. REDUCE-IT results have been
accepted for presentation at the 2018 Scientific Sessions of the American Heart Association (AHA) on November 10, 2018 in Chicago, Illinois. The
presentation, classified as late breaking clinical trial results, is scheduled to commence at 2:16 pm Central Time and listed as Main Event 1 for the time
frame. This acceptance as a presentation of late-breaking clinical trial results was granted based on the ability of REDUCE-IT to address a critical
question in cardiovascular prevention.
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Schlussfolgerungen
• Magere Studienlage
• Viele kleine Studien
• Heterogenität (Konzentrationen, Kombinationen, Beobachtungszeit)
• Folsäuesupplementierung evidenzbasiert
• Vitamin B12 bei nachgewiesenem Mangel auch oral
• Vitamin A, Carotenoide in Nahrungsmittel bevorzugen
• Omega-3-Fettsäuren reduzieren kardiovaskuläre Ereignisse