Cited by 1,209Antioxidant Activity and Oxidative StressNutritional Studies and DietVitamin D Research Studies

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Effects of Long-term Vitamin E Supplementation on Cardiovascular Events and Cancer: A Randomized Controlled Trial

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The HOPE and HOPE-TOO Trial Investigators·2005·JAMA

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Abstract

CONTEXT: Experimental and epidemiological data suggest that vitamin E supplementation may prevent cancer and cardiovascular events. Clinical trials have generally failed to confirm benefits, possibly due to their relatively short duration. OBJECTIVE: To evaluate whether long-term supplementation with vitamin E decreases the risk of cancer, cancer death, and major cardiovascular events. DESIGN, SETTING, AND PATIENTS: A randomized, double-blind, placebo-controlled international trial (the initial Heart Outcomes Prevention Evaluation [HOPE] trial conducted between December 21, 1993, and April 15, 1999) of patients at least 55 years old with vascular disease or diabetes mellitus was extended (HOPE-The Ongoing Outcomes [HOPE-TOO]) between April 16, 1999, and May 26, 2003. Of the initial 267 HOPE centers that had enrolled 9541 patients, 174 centers participated in the HOPE-TOO trial. Of 7030 patients enrolled at these centers, 916 were deceased at the beginning of the extension, 1382 refused participation, 3994 continued to take the study intervention, and 738 agreed to passive follow-up. Median duration of follow-up was 7.0 years. INTERVENTION: Daily dose of natural source vitamin E (400 IU) or matching placebo. MAIN OUTCOME MEASURES: Primary outcomes included cancer incidence, cancer deaths, and major cardiovascular events (myocardial infarction, stroke, and cardiovascular death). Secondary outcomes included heart failure, unstable angina, and revascularizations. RESULTS: Among all HOPE patients, there were no significant differences in the primary analysis: for cancer incidence, there were 552 patients (11.6%) in the vitamin E group vs 586 (12.3%) in the placebo group (relative risk [RR], 0.94; 95% confidence interval [CI], 0.84-1.06; P = .30); for cancer deaths, 156 (3.3%) vs 178 (3.7%), respectively (RR, 0.88; 95% CI, 0.71-1.09; P = .24); and for major cardiovascular events, 1022 (21.5%) vs 985 (20.6%), respectively (RR, 1.04; 95% CI, 0.96-1.14; P = .34). Patients in the vitamin E group had a higher risk of heart failure (RR, 1.13; 95% CI, 1.01-1.26; P = .03) and hospitalization for heart failure (RR, 1.21; 95% CI, 1.00-1.47; P = .045). Similarly, among patients enrolled at the centers participating in the HOPE-TOO trial, there were no differences in cancer incidence, cancer deaths, and major cardiovascular events, but higher rates of heart failure and hospitalizations for heart failure. CONCLUSION: In patients with vascular disease or diabetes mellitus, long-term vitamin E supplementation does not prevent cancer or major cardiovascular events and may increase the risk for heart failure.

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Background
Pharmacological approaches to coronary microvascular dysfunction
Guarini, G., Huqi, A., Morrone, D., Capozza, P., Todiere, G., & Marzilli, M. (2014) · Pharmacology & Therapeutics · doi:10.1016/j.pharmthera.2014.06.008 · Cited by 31
Algorithm for Complementary and Alternative Medicine Practice and Research in Type 2 Diabetes
Bradley, R. D., Oberg, E. B., Calabrese, C., & Standish, L. J. (2007) · The Journal of Alternative and Complementary Medicine · doi:10.1089/acm.2006.6207 · Cited by 30
[Antioxidants and diabetes mellitus: review of the evidence].
Cuerda, C., Luengo, L. M., Valero, M. A., Vidal, A., Peláez, R. B., Calvo, F. L., & Martínez, C. (2011) · PubMed · Cited by 31
Patient selection and vitamin E treatment in diabetes mellitus
Goldenstein, H., Levy, N. S., Lipener, Y. T., & Levy, A. P. (2013) · Expert Review of Cardiovascular Therapy · doi:10.1586/erc.12.187 · Cited by 30
Entacapone is an Antioxidant More Potent than Vitamin C and Vitamin E for Scavenging of Hypochlorous Acid and Peroxynitrite, and the Inhibition of Oxidative Stress-Induced Cell Death
Chen, A. Y., Lü, J.-M., Yao, Q. C., & Chen, C. (2016) · Medical Science Monitor · doi:10.12659/msm.896462 · Cited by 30
Vitamin Metabolism and Requirements in Renal Disease and Renal Failure
Chazot, C., & Kopple, J. D. (2012) · Elsevier eBooks · doi:10.1016/b978-0-12-391934-2.00024-2 · Cited by 30
Dietary antioxidants and melanoma: Evidence from cohort and intervention studies
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Treatment Practices of Mild Cognitive Impairment in California Alzheimer's Disease Centers
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“Although vitamin E and other antioxidants may have beneficial effects on cognition, they are not generally recommended for dementia treatment because of a risk of heart failure and mortality.(5,24) In addition, vitamin E has not shown any significant benefit for slowing the progression to dementia in patients with MCI…”
Background
Dietary Total Antioxidant Capacity is Inversely Associated with Prostate Cancer Aggressiveness in a Population-Based Study
Vance, T. M., Wang, Y., Su, L. J., Fontham, E. T. H., Steck, S. E., Arab, L., Bensen, J. T., Mohler, J. L., Chen, M., & Chun, O. K. (2016) · Nutrition and Cancer · doi:10.1080/01635581.2016.1134596 · Cited by 29
“other studies have found no effect of vitamin E on prostate cancer risk (31-33).”
Background
Dietary intakes of fat soluble vitamins as predictors of mortality from heart failure in a large prospective cohort study
Eshak, E. S., Iso, H., Yamagishi, K., Cui, R., & Tamakoshi, A. (2017) · Nutrition · doi:10.1016/j.nut.2017.09.009 · Cited by 29
Use of Herbal Medicines and Nutritional Supplements in Ocular Disorders
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Micronutrient intake in relation to all-cause mortality in a prospective Danish cohort
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Efficacy of various antioxidants in the protection of the retinal pigment epithelium from oxidative stress
Hutnik, C. M. L., Kagan, D. B., & Liu, H. (2012) · Clinical ophthalmology · doi:10.2147/opth.s35139 · Cited by 28
Analysis of Flavanols in Foods: What Methods are Required to Enable Meaningful Health Recommendations?
Robbins, R. J., Kwik-Uribe, C. L., Hammerstone, J. F., & Schmitz, H. H. (2006) · Journal of Cardiovascular Pharmacology · doi:10.1097/00005344-200606001-00004 · Cited by 30
Primary prevention of coronary heart disease in women
Rees, M., & Stevenson, J. C. (2008) · Menopause international · doi:10.1258/mi.2007.007037 · Cited by 29
Improvement of genetic stability in lymphocytes from Fanconi anemia patients through the combined effect of α-lipoic acid and N-acetylcysteine
Ponte, F., Sousa, R., Fernandes, A., Gonçalves, C., Barbot, J., Carvalho, F. D., & Porto, B. (2012) · Orphanet Journal of Rare Diseases · doi:10.1186/1750-1172-7-28 · Cited by 29
“Several studies have shown that the provision of individual antioxidants as supplements are either ineffective [53], or can be deleterious to health [54].”
Background
Green Tea and Vitamin E Enhance Exercise-Induced Benefits in Body Composition, Glucose Homeostasis, and Antioxidant Status in Elderly Men and Women
Narotzki, B., Reznick, A. Z., Mintzer, D. N., Dagan, B., & Levy, Y. (2013) · Journal of the American College of Nutrition · doi:10.1080/07315724.2013.767661 · Cited by 29
“Though one study found that daily dose of 400 IU vitamin E may be deleterious in patients with vascular disease or diabetes mellitus [27], the majority of studies have shown that daily vitamin E supplementation of less than 1000 IU was safe in healthy individuals and may lead to reduced risks of cardiovascular disease…”
Background
Application of pharmacogenomics in the prevention of diabetic cardiovascular disease: Mechanistic basis and clinical evidence for utilization of the haptoglobin genotype in determining benefit from antioxidant therapy
Levy, A. P. (2006) · Pharmacology & Therapeutics · doi:10.1016/j.pharmthera.2006.05.002 · Cited by 29
Cardiovascular Risk Associated with Celecoxib
Brophy, J. M. (2005) · New England Journal of Medicine · doi:10.1056/nejm200506233522519 · Cited by 29
Dietary vitamin E intake and new-onset hypertension
Zhang, Y., Yang, S., Wu, Q., Ye, Z., Zhou, C., Liu, M., Zhang, Z., He, P., Zhang, Y., Li, H., et al. (2023) · Hypertension Research · doi:10.1038/s41440-022-01163-0 · Cited by 30
“Consistently, several studies have revealed the detrimental role of high levels of vitamin E on mortality [30], heart failure and hospitalization for heart failure [31].”
Background
Strategies for the discovery of anti-aging compounds
Rizvi, S. I., & Jha, R. (2010) · Expert Opinion on Drug Discovery · doi:10.1517/17460441.2011.533653 · Cited by 28
“However, a human study suggested an unexpected increased risk of heart failure associated with long-term supplementation of a-tocopherol [55].”
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Pharmacological and dietary prevention for colorectal cancer
Nolfo, F., Rametta, S., Marventano, S., Grosso, G., Mistretta, A., Drago, F., Gangi, S., Basile, F., & Biondi, A. (2013) · BMC Surgery · doi:10.1186/1471-2482-13-s2-s16 · Cited by 27
“Several studies specifically investigated the association between antioxidants, administered alone or in combination, and CRC risk among general population [63,99, 122-131].”
Background
Assessment of Tocopherol Metabolism and Oxidative Stress in Familial Hypobetalipoproteinemia
Clarke, M. W., Hooper, A. J., Headlam, H. A., Wu, J. H. Y., Croft, K. D., & Burnett, J. R. (2006) · Clinical Chemistry · doi:10.1373/clinchem.2006.068692 · Cited by 28
“Results of a recent metaanalysis, however, suggest that supplementation with 400 IU of -tocopherol per day might increase the risk of heart failure ( 7 ) or all-cause mortality (8) in certain population groups.”
Background
Catalase Enhances Viability of Human Chondrocytes in Culture by Reducing Reactive Oxygen Species and Counteracting Tumor Necrosis Factor-α-Induced Apoptosis
Li, S.-M., Yang, X.-H., Feng, Z., Wang, P., Zhu, W.-C., & Cui, S.-L. (2018) · Cellular Physiology and Biochemistry · doi:10.1159/000493841 · Cited by 31
Benefits of multiple micronutrient supplementation in heart failure: A comprehensive review
Dragan, S. R., Buleu, F. N., Christodorescu, R., Cobzariu, F., Iurciuc, S., Velimirovici, D. E., Xiao, J., & Luca, C. T. (2018) · Critical Reviews in Food Science and Nutrition · doi:10.1080/10408398.2018.1540398 · Cited by 28
An update on chemoprevention strategies in prostate cancer for 2006
Neill, M. G., & Fleshner, N. E. (2006) · Current Opinion in Urology · doi:10.1097/01.mou.0000193388.31727.d2 · Cited by 28
Treatment - Therapeutic Lifestyle Modification
Teramoto, T., Sasaki, J., Ueshima, H., Egusa, G., Kinoshita, M., Shimamoto, K., Daida, H., Biro, S., Hirobe, K., Funahashi, T., et al. (2008) · Journal of Atherosclerosis and Thrombosis · doi:10.5551/jat.e601 · Cited by 26
Vitamin Supplement Use in Patients With CKD: Worth the Pill Burden?
Wang, A. Y.-M., Afşar, R. E., Sussman, E. J., White, J., MacLaughlin, H. L., & Ikizler, T. A. (2023) · American Journal of Kidney Diseases · doi:10.1053/j.ajkd.2023.09.005 · Cited by 27
Cardiovascular, kidney, and metabolic health: an actionable vision for heart failure prevention
Ostrominski, J. W., CHENG, A. Y. Y., Nelson, A. J., Neuen, B. L., Sattar, N. A., Tuttle, K. R., & Vaduganathan, M. (2025) · The Lancet · doi:10.1016/s0140-6736(25)01384-4 · Cited by 32
Does Vitamin Supplementation Play a Role in Chronic Kidney Disease?
Juszczak, A. B., Kupczak, M., & Konecki, T. (2023) · Nutrients · doi:10.3390/nu15132847 · Cited by 27
“Thus, these studies suggest that among people at a high risk for cardiovascular events, vitamin E supplementation may not be advisable [88,92].”
Background
Application of Molecularly Imprinted Polymer Appended onto CdSe/ZnS Quantum Dots for Optosensing of Tocopherol in Rice
Liu, H., Fang, G., Zhu, H., & Wang, S. (2013) · Food Analytical Methods · doi:10.1007/s12161-013-9768-4 · Cited by 27
“In some cancer and cardiovascular and neurological diseases, tocopherol has a preventive action and it is also a part of the primary defense system of the body tissues (Lonn 2005; Coulter et al. 2006; Hathcock et al. 2005).”
Background
Excessive α‐tocopherol exacerbates microglial activation and brain injury caused by acute ischemic stroke
Khanna, S., Heigel, M., Weist, J. L., Gnyawali, S. C., Teplitsky, S. L., Roy, S., Sen, C. K., & Rink, C. L. (2014) · The FASEB Journal · doi:10.1096/fj.14-263723 · Cited by 27
Testosterone reduces AGTR1 expression to prevent β-cell and islet apoptosis from glucotoxicity
Kooptiwut, S., Hanchang, W., Semprasert, N., Junking, M., Limjindaporn, T., & Yenchitsomanus, P. (2014) · Journal of Endocrinology · doi:10.1530/joe-14-0397 · Cited by 27
“Although the accumulation of oxidative stress has been proposed to be a major mechanism of glucotoxicity, antioxidant substances have been shown to confer only partial protection against pancreatic b-cell death due to glucotoxicity (Lonn et al. 2005).”
Background
Reactive Oxygen Species, Oxidative Stress, and Vascular Biology in Hypertension
Tabet, F., & Touyz, R. M. (2007) · Elsevier eBooks · doi:10.1016/b978-0-323-03961-1.50033-7 · Cited by 30
Hypouricemic Effect of Ethanol Extract of Aster glehni Leaves in Potassium Oxonate-Induced Hyperuricemic Rats
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One is okay, more is better? Pharmacological aspects and safe limits of nutritional supplements
Mason, P. (2007) · Proceedings of The Nutrition Society · doi:10.1017/s0029665107005812 · Cited by 27
“Extended follow up of the Heart Outcomes Prevention Evaluation Study has actually suggested an increased risk of heart failure in the vitamin E-supplemented group((61)).”
Background
Obligatory role of neuronal nitric oxide synthase in the heart's antioxidant adaptation with exercise
Roof, S. R., Ho, H., Little, S. C., Ostler, J. E., Brundage, E. A., Periasamy, M., Villamena, F. A., Györke, S., Biesiadecki, B. J., Heymes, C., et al. (2015) · Journal of Molecular and Cellular Cardiology · doi:10.1016/j.yjmcc.2015.01.003 · Cited by 26
“Unfortunately, clinical trials investigating the effects of antioxidants on heart failure have been disappointing [2,3].”
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Barriers to preventive therapy for breast and other major cancers and strategies to improve uptake
DeCensi, A. (2015) · ecancermedicalscience · doi:10.3332/ecancer.2015.595 · Cited by 28
Cardiovascular function in male and female JCR:LA-cp rats: effect of high-fat/high-sucrose diet
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(–)-Epicatechin Modulates Mitochondrial Redox in Vascular Cell Models of Oxidative Stress
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Novel Pathogenic Insights in the Primary Prevention of Cardiovascular Disease
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Integrative Medicine and Gastrointestinal Disease
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Dual Therapy With Statins and Antioxidants Is Superior to Statins Alone in Decreasing the Risk of Cardiovascular Disease in a Subgroup of Middle-Aged Individuals With Both Diabetes Mellitus and the Haptoglobin 2-2 Genotype
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Authors: The HOPE and HOPE-TOO Trial Investigators
Affiliations: Population Health Research Institute (CA)
Corresponding author: The HOPE and HOPE-TOO Trial Investigators
Venue: JAMA
Publisher: American Medical Association (AMA)
Published: 2005-03-16
Volume: 293
Issue: 11
Pages: 1338
ISSN: 0002-9955 (ISSN-L)
0098-7484
DOI: 10.1001/jama.293.11.1338
OpenAlex: W1678920698
Cited by: 1,209
References: 20
Citations by year: 2026: 26 · 2025: 26 · 2024: 31 · 2023: 35 · 2022: 35 · 2021: 34 · 2020: 45 · 2019: 37 · 2018: 22 · 2017: 44 · 2016: 48 · 2015: 56 · 2014: 95 · 2013: 70 · 2012: 87
FWCI: 58.51
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: JAMA (publishedVersion)
PubMed (publishedVersion)
Funders: Medical Research Council Canada
Topics: Health Sciences › Medicine › Biochemistry (medical) › Antioxidant Activity and Oxidative Stress
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Nutritional Studies and Diet
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Vitamin D Research Studies
Keywords: vitamin E supplementation, long-term supplementation, cancer incidence, cancer mortality, cardiovascular events, myocardial infarction, stroke, cardiovascular mortality, heart failure, unstable angina, revascularization, older adults, vascular disease, diabetes mellitus
MeSH terms: Aged, Antioxidants, Cardiovascular Diseases, Diabetes Mellitus, Double-Blind Method, Female, Humans, Male, Middle Aged, Neoplasms, Risk, Vascular Diseases, Dietary Supplements, alpha-Tocopherol

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Effects of Long-term Vitamin E Supplementation on Cardiovascular Events and Cancer: A Randomized Controlled Trial

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