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Women's Health Study (WHS): A Randomized Trial of Low-Dose Aspirin and Vitamin E in the Primary Prevention of Cardiovascular Disease and Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00000479
  Purpose

The purpose of this study is to evaluate the effects of vitamin E and low-dose aspirin in primary prevention of cardiovascular disease and cancer in apparently healthy women.


Condition Intervention Phase
Cardiovascular Diseases
Cerebrovascular Disorders
Coronary Disease
Heart Diseases
Myocardial Infarction
Myocardial Ischemia
Vascular Diseases
Drug: Aspirin
Drug: Vitamin E
Behavioral: Placebo
Phase III

MedlinePlus related topics: Cancer Coronary Artery Disease Heart Attack Heart Disease in Women Heart Diseases Vascular Diseases Women's Health
Drug Information available for: Vitamin E alpha-Tocopherol alpha-Tocopheryl acetate Tocopherols Acetylsalicylic acid
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment
Official Title: Women's Health Study of Low-Dose Aspirin and Vitamin E in Apparently Healthy Women

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Reduction of the risk of all important vascular events (a combined endpoint of nonfatal myocardial infarction, nonfatal stroke, and total cardiovascular death) and a decrease in the incidence of total malignant neoplasms of epithelial cell origin [ Time Frame: Measured throughout the study ] [ Designated as safety issue: No ]

Enrollment: 39876
Study Start Date: September 1991
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Vitamin E (600 IU every other day) and aspirin (100 mg every other day)
Drug: Aspirin
Participants will receive 100 mg of aspirin every other day.
Drug: Vitamin E
Participants will receive 600 IU of vitamin E every other day.
2: Active Comparator
Vitamin E (600 IU every other day) and placebo
Drug: Vitamin E
Participants will receive 600 IU of vitamin E every other day.
Behavioral: Placebo
Participants will receive placebo.
3: Active Comparator
Placebo and aspirin (100 mg every other day)
Drug: Aspirin
Participants will receive 100 mg of aspirin every other day.
Behavioral: Placebo
Participants will receive placebo.
4: Placebo Comparator
Placebo and placebo
Behavioral: Placebo
Participants will receive placebo.

Detailed Description:

BACKGROUND:

Various doses of aspirin have been shown to be effective in preventing thrombosis or vascular occlusion in several clinical conditions. Short-term studies have documented the efficacy of aspirin in preventing occlusion of saphenous vein bypass grants, preventing myocardial infarction in patients with unstable angina, preventing transient ischemic attacks and stroke in men with cerebral vascular disease, preventing occlusion of injured coronary arteries following transluminal angioplasty and aiding in reducing myocardial infarction and total mortality in patients receiving fibrinolytic therapy. Additionally, aspirin has been effective in the secondary prevention of myocardial infarction in subjects with known coronary artery disease. The results of the Physicians' Health Study, a large-scale primary prevention trial of aspirin in male physicians, have shown a decrease in myocardial infarction, a non-significant increase in cerebral vascular events, and no difference in overall mortality. However, few studies have addressed the efficacy of aspirin in vascular diseases in women, and it is possible that the risk to benefit ratio may be different in women. Specifically, there have been no large primary prevention trials in women, who are at risk of coronary heart disease, especially after menopause.

DESIGN NARRATIVE:

The Women's Health Study (WHS) is a randomized, double-blind, placebo-controlled trial using a 2x2 factorial design. The WHS is sponsored by both NHBLI (HL080467) and NCI (CA047988). Participants were randomly assigned to either Vitamin E (600 IU every other day) or placebo; and to aspirin (100 mg every other day) or placebo. Approximately 1.75 million female health professionals were contacted by mail to determine if they were suitable for inclusion in the study. A three-month run-in phase was performed to screen out those with poor compliance. Randomization, which began in February 1993 and ended in January 1996, was stratified on five-year age groups. The primary endpoint is the reduction of the risk of all important vascular events (a combined endpoint of nonfatal myocardial infarction, nonfatal stroke, and total cardiovascular death) and a decrease in the incidence of total malignant neoplasms of epithelial cell origin. Secondary endpoints are the individual components of the combined endpoints. Compliance is measured by replies to a questionnaire sent out every year.

The WHS has been extended through March, 2009 for additional observational follow-up of the cohort. As part of the initial trial, pre-randomization blood samples from 28,345 participants were frozen and stored for genetic analysis which has been supported by non-federal sources. The study will develop improved prediction scores for total and specific cardiovascular disease outcomes that are based not only on traditional risk factors but also on novel plasma and genetic markers. The study will also develop similar prediction scores for health conditions that are major cardiovascular disease risk factors (including type 2 diabetes, hypertension, and the metabolic syndrome) and will evaluate genotype-phenotype interactions and interactions between traditional and novel cardiovascular disease risk factors in the prediction of cardiovascular disease events.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy women
  • No previous history of cardiovascular disease or cancer
  • No contraindications to aspirin or vitamin E
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000479

Sponsors and Collaborators
Investigators
Principal Investigator: Julie Buring Brigham and Women's Hospital
  More Information

Publications:
Ridker PM, Miletich JP, Hennekens CH, Buring JE. Ethnic distribution of factor V Leiden in 4047 men and women. Implications for venous thromboembolism screening. JAMA. 1997 Apr 23-30;277(16):1305-7.
Ridker PM, Buring JE, Shih J, Matias M, Hennekens CH. Prospective study of C-reactive protein and the risk of future cardiovascular events among apparently healthy women. Circulation. 1998 Aug 25;98(8):731-3.
Ridker PM, Hennekens CH, Rifai N, Buring JE, Manson JE. Hormone replacement therapy and increased plasma concentration of C-reactive protein. Circulation. 1999 Aug 17;100(7):713-6.
Lee IM, Cook NR, Manson JE, Buring JE, Hennekens CH. Beta-carotene supplementation and incidence of cancer and cardiovascular disease: the Women's Health Study. J Natl Cancer Inst. 1999 Dec 15;91(24):2102-6.
Rexrode KM, Lee IM, Cook NR, Hennekens CH, Buring JE. Baseline characteristics of participants in the Women's Health Study. J Womens Health Gend Based Med. 2000 Jan-Feb;9(1):19-27.
Liu S, Manson JE, Lee IM, Cole SR, Hennekens CH, Willett WC, Buring JE. Fruit and vegetable intake and risk of cardiovascular disease: the Women's Health Study. Am J Clin Nutr. 2000 Oct;72(4):922-8.
Lee IM, Rexrode KM, Cook NR, Manson JE, Buring JE. Physical activity and coronary heart disease in women: is "no pain, no gain" passe? JAMA. 2001 Mar 21;285(11):1447-54.
Pradhan AD, Manson JE, Rifai N, Buring JE, Ridker PM. C-reactive protein, interleukin 6, and risk of developing type 2 diabetes mellitus. JAMA. 2001 Jul 18;286(3):327-34.
Sesso HD, Lee IM, Gaziano JM, Rexrode KM, Glynn RJ, Buring JE. Maternal and paternal history of myocardial infarction and risk of cardiovascular disease in men and women. Circulation. 2001 Jul 24;104(4):393-8.
Ridker PM, Hennekens CH, Buring JE, Rifai N. C-reactive protein and other markers of inflammation in the prediction of cardiovascular disease in women. N Engl J Med. 2000 Mar 23;342(12):836-43.
Blake GJ, Otvos JD, Rifai N, Ridker PM. Low-density lipoprotein particle concentration and size as determined by nuclear magnetic resonance spectroscopy as predictors of cardiovascular disease in women. Circulation. 2002 Oct 8;106(15):1930-7.
Cook NR, Bensenor IM, Lotufo PA, Lee IM, Skerrett PJ, Chown MJ, Ajani UA, Manson JE, Buring JE. Migraine and coronary heart disease in women and men. Headache. 2002 Sep;42(8):715-27.
Liu S, Manson JE, Buring JE, Stampfer MJ, Willett WC, Ridker PM. Relation between a diet with a high glycemic load and plasma concentrations of high-sensitivity C-reactive protein in middle-aged women. Am J Clin Nutr. 2002 Mar;75(3):492-8.
Porch JV, Lee IM, Cook NR, Rexrode KM, Burin JE. Estrogen-progestin replacement therapy and breast cancer risk: the Women's Health Study (United States). Cancer Causes Control. 2002 Nov;13(9):847-54.
Ridker PM, Rifai N, Rose L, Buring JE, Cook NR. Comparison of C-reactive protein and low-density lipoprotein cholesterol levels in the prediction of first cardiovascular events. N Engl J Med. 2002 Nov 14;347(20):1557-65.
Ridker PM, Buring JE, Cook NR, Rifai N. C-reactive protein, the metabolic syndrome, and risk of incident cardiovascular events: an 8-year follow-up of 14 719 initially healthy American women. Circulation. 2003 Jan 28;107(3):391-7.
Pradhan AD, Manson JE, Meigs JB, Rifai N, Buring JE, Liu S, Ridker PM. Insulin, proinsulin, proinsulin:insulin ratio, and the risk of developing type 2 diabetes mellitus in women. Am J Med. 2003 Apr 15;114(6):438-44.
Janket SJ, Manson JE, Sesso H, Buring JE, Liu S. A prospective study of sugar intake and risk of type 2 diabetes in women. Diabetes Care. 2003 Apr;26(4):1008-15.
Atiya M, Kurth T, Berger K, Buring JE, Kase CS; Women's Health Study. Interobserver agreement in the classification of stroke in the Women's Health Study. Stroke. 2003 Feb;34(2):565-7.
Ridker PM, Cook N. Clinical usefulness of very high and very low levels of C-reactive protein across the full range of Framingham Risk Scores. Circulation. 2004 Apr 27;109(16):1955-9. Epub 2004 Mar 29.
Albert MA, Glynn RJ, Buring J, Ridker PM. C-reactive protein levels among women of various ethnic groups living in the United States (from the Women's Health Study). Am J Cardiol. 2004 May 15;93(10):1238-42.
Lin J, Zhang SM, Cook NR, Lee IM, Buring JE. Dietary fat and fatty acids and risk of colorectal cancer in women. Am J Epidemiol. 2004 Nov 15;160(10):1011-22.
Weinstein AR, Sesso HD, Lee IM, Cook NR, Manson JE, Buring JE, Gaziano JM. Relationship of physical activity vs body mass index with type 2 diabetes in women. JAMA. 2004 Sep 8;292(10):1188-94.
Christen W, Glynn R, Sperduto R, Chew E, Buring J. Age-related cataract in a randomized trial of beta-carotene in women. Ophthalmic Epidemiol. 2004 Dec;11(5):401-12.
Zhang SM, Buring JE, Lee IM, Cook NR, Ridker PM. C-reactive protein levels are not associated with increased risk for colorectal cancer in women. Ann Intern Med. 2005 Mar 15;142(6):425-32.
Kurth T, Gaziano JM, Rexrode KM, Kase CS, Cook NR, Manson JE, Buring JE. Prospective study of body mass index and risk of stroke in apparently healthy women. Circulation. 2005 Apr 19;111(15):1992-8.
Levitan EB, Ridker PM, Manson JE, Stampfer MJ, Buring JE, Cook NR, Liu S. Association Between Consumption of Beer, Wine, and Liquor and Plasma Concentration of High-Sensitivity C-Reactive Protein in Women Aged 39 to 89 Years. Am J Cardiol. 2005 Jul 1;96(1):83-88.
Lee IM, Cook NR, Gaziano JM, Gordon D, Ridker PM, Manson JE, Hennekens CH, Buring JE. Vitamin E in the primary prevention of cardiovascular disease and cancer: the Women's Health Study: a randomized controlled trial. JAMA. 2005 Jul 6;294(1):56-65.
Cook NR, Lee IM, Gaziano JM, Gordon D, Ridker PM, Manson JE, Hennekens CH, Buring JE. Low-dose aspirin in the primary prevention of cancer: the Women's Health Study: a randomized controlled trial. JAMA. 2005 Jul 6;294(1):47-55.
Ridker PM, Rifai N, Cook NR, Bradwin G, Buring JE. Non-HDL cholesterol, apolipoproteins A-I and B100, standard lipid measures, lipid ratios, and CRP as risk factors for cardiovascular disease in women. JAMA. 2005 Jul 20;294(3):326-33.
Ridker PM, Cook NR, Lee IM, Gordon D, Gaziano JM, Manson JE, Hennekens CH, Buring JE. A Randomized Trial of Low-Dose Aspirin in the Primary Prevention of Cardiovascular Disease in Women. N Engl J Med. 2005 Mar 7; [Epub ahead of print]
Bassuk SS, Ridker PM, Manson JE, Buring JE. Aspirin and cardiovascular disease prevention in women: new findings from the Women's Health Study. Women's Health, 1:9-10, 2005.
Conroy MB, Cook NR, Manson JE, Buring JE, Lee IM. Past physical activity, current physical activity, and risk of coronary heart disease. Med Sci Sports Exerc. 2005 Aug;37(8):1251-6.
Lin J, Zhang SM, Cook NR, Manson JE, Lee IM, Buring JE. Intakes of calcium and vitamin D and risk of colorectal cancer in women. Am J Epidemiol. 2005 Apr 15;161(8):755-64.
Lin J, Zhang SM, Cook NR, Rexrode KM, Liu S, Manson JE, Lee IM, Buring JE. Dietary intakes of fruit, vegetables, and fiber, and risk of colorectal cancer in a prospective cohort of women (United States). Cancer Causes Control. 2005 Apr;16(3):225-33.
Blake GJ, Rifai N, Buring JE, Ridker PM. Blood pressure, C-reactive protein, and risk of future cardiovascular events. Circulation. 2003 Dec 16;108(24):2993-9. Epub 2003 Nov 24.
Rexrode KM, Manson JE, Lee IM, Ridker PM, Sluss PM, Cook NR, Buring JE. Sex hormone levels and risk of cardiovascular events in postmenopausal women. Circulation. 2003 Oct 7;108(14):1688-93. Epub 2003 Sep 15.
Sesso HD, Buring JE, Rifai N, Blake GJ, Gaziano JM, Ridker PM. C-reactive protein and the risk of developing hypertension. JAMA. 2003 Dec 10;290(22):2945-51.
Liu S, Serdula M, Janket SJ, Cook NR, Sesso HD, Willett WC, Manson JE, Buring JE. A prospective study of fruit and vegetable intake and the risk of type 2 diabetes in women. Diabetes Care. 2004 Dec;27(12):2993-6. No abstract available.
Buring JE, Hennekens CH for the Women's Health Study Research Group. The Women's Health Study: rationale and background. J Myocardial Ischemia, 4:30-40, 1992.
Buring JE, Hennekens CH for the Women's Health Study Research Group. The Women's Health Study: rationale and background. J Myocardial Ischemia, 4:30-40, 1992.
Sesso HD, Buring JE, Norkus EP, Gaziano JM. Plasma lycopene, other carotenoids, and retinol and the risk of cardiovascular disease in women. Am J Clin Nutr. 2004 Jan;79(1):47-53.
Song Y, Manson JE, Buring JE, Liu S. Dietary magnesium intake in relation to plasma insulin levels and risk of type 2 diabetes in women. Diabetes Care. 2004 Jan;27(1):59-65.
Song Y, Manson JE, Buring JE, Liu S. A prospective study of red meat consumption and type 2 diabetes in middle-aged and elderly women: the women's health study. Diabetes Care. 2004 Sep;27(9):2108-15.
Kurth T, Kase CS, Berger K, Gaziano JM, Cook NR, Buring JE. Smoking and risk of hemorrhagic stroke in women. Stroke. 2003 Dec;34(12):2792-5. Epub 2003 Nov 13.
Misakian AL, Langer RD, Bensenor IM, Cook NR, Manson JE, Buring JE, Rexrode KM. Postmenopausal hormone therapy and migraine headache. J Womens Health (Larchmt). 2003 Dec;12(10):1027-36.
Pradhan AD, Cook NR, Buring JE, Manson JE, Ridker PM. C-reactive protein is independently associated with fasting insulin in nondiabetic women. Arterioscler Thromb Vasc Biol. 2003 Apr 1;23(4):650-5. Epub 2003 Mar 06.
Rexrode KM, Pradhan A, Manson JE, Buring JE, Ridker PM. Relationship of total and abdominal adiposity with CRP and IL-6 in women. Ann Epidemiol. 2003 Nov;13(10):674-82.
Schaumberg DA, Sullivan DA, Buring JE, Dana MR. Prevalence of dry eye syndrome among US women. Am J Ophthalmol. 2003 Aug;136(2):318-26.
Sesso HD, Chen RS, L'Italien GJ, Lapuerta P, Lee WC, Glynn RJ. Blood pressure lowering and life expectancy based on a Markov model of cardiovascular events. Hypertension. 2003 Nov;42(5):885-90. Epub 2003 Oct 13.
Sesso HD, Gaziano JM, Liu S, Buring JE. Flavonoid intake and the risk of cardiovascular disease in women. Am J Clin Nutr. 2003 Jun;77(6):1400-8.
Sesso HD, Liu S, Gaziano JM, Buring JE. Dietary lycopene, tomato-based food products and cardiovascular disease in women. J Nutr. 2003 Jul;133(7):2336-41.
Bermudez EA, Rifai N, Buring J, Manson JE, Ridker PM. Interrelationships among circulating interleukin-6, C-reactive protein, and traditional cardiovascular risk factors in women. Arterioscler Thromb Vasc Biol. 2002 Oct 1;22(10):1668-73.
Bermudez EA, Rifai N, Buring JE, Manson JE, Ridker PM. Relation between markers of systemic vascular inflammation and smoking in women. Am J Cardiol. 2002 May 1;89(9):1117-9. No abstract available.
Brown DA, Breit SN, Buring J, Fairlie WD, Bauskin AR, Liu T, Ridker PM. Concentration in plasma of macrophage inhibitory cytokine-1 and risk of cardiovascular events in women: a nested case-control study. Lancet. 2002 Jun 22;359(9324):2159-63.
Glynn RJ, L'Italien GJ, Sesso HD, Jackson EA, Buring JE. Development of predictive models for long-term cardiovascular risk associated with systolic and diastolic blood pressure. Hypertension. 2002 Jan;39(1):105-10.
Lee IM, Cook NR, Manson JE, Buring JE. Randomised beta-carotene supplementation and incidence of cancer and cardiovascular disease in women: is the association modified by baseline plasma level? Br J Cancer. 2002 Mar 4;86(5):698-701.
Liu S, Buring JE, Sesso HD, Rimm EB, Willett WC, Manson JE. A prospective study of dietary fiber intake and risk of cardiovascular disease among women. J Am Coll Cardiol. 2002 Jan 2;39(1):49-56.
Rifai N, Buring JE, Lee IM, Manson JE, Ridker PM. Is C-reactive protein specific for vascular disease in women? Ann Intern Med. 2002 Apr 2;136(7):529-33. Summary for patients in: Ann Intern Med. 2002 Apr 2;136(7):I42.
Bensenor IM, Cook NR, Lee IM, Chown MJ, Hennekens CH, Buring JE, Manson JE. Active and passive smoking and risk of colds in women. Ann Epidemiol. 2001 May;11(4):225-31.
Bensenor IM, Cook NR, Lee IM, Chown MJ, Hennekens CH, Buring JE. Low-dose aspirin for migraine prophylaxis in women. Cephalalgia. 2001 Apr;21(3):175-83.
Karlson EW, Lee IM, Cook NR, Buring JE, Hennekens CH, Bloch KJ. Serologic evaluations of women exposed to breast implants. J Rheumatol. 2001 Jul;28(7):1523-30.
Lee IM, Cook NR, Rexrode KM, Buring JE. Lifetime physical activity and risk of breast cancer. Br J Cancer. 2001 Sep 28;85(7):962-5.
Lee IM, Rexrode KM, Cook NR, Hennekens CH, Burin JE. Physical activity and breast cancer risk: the Women's Health Study (United States). Cancer Causes Control. 2001 Feb;12(2):137-45.
Ridker PM, Buring JE, Rifai N. Soluble P-selectin and the risk of future cardiovascular events. Circulation. 2001 Jan 30;103(4):491-5.
Schaumberg DA, Buring JE, Sullivan DA, Dana MR. Hormone replacement therapy and dry eye syndrome. JAMA. 2001 Nov 7;286(17):2114-9.
Schonbeck U, Varo N, Libby P, Buring J, Ridker PM. Soluble CD40L and cardiovascular risk in women. Circulation. 2001 Nov 6;104(19):2266-8.
Schaumberg DA, Christen WG, Glynn RJ, Buring JE. Demographic predictors of eye care utilization among women. Med Care. 2000 Jun;38(6):638-46.
Karlson EW, Lee IM, Cook NR, Manson JE, Buring JE, Hennekens CH. Comparison of self-reported diagnosis of connective tissue disease with medical records in female health professionals: the Women's Health Cohort Study. Am J Epidemiol. 1999 Sep 15;150(6):652-60.
Karlson EW, Lee IM, Cook NR, Manson JE, Buring JE, Hennekens CH. A retrospective cohort study of cigarette smoking and risk of rheumatoid arthritis in female health professionals. Arthritis Rheum. 1999 May;42(5):910-7.
Ridker PM, Hennekens CH, Buring JE, Kundsin R, Shih J. Baseline IgG antibody titers to Chlamydia pneumoniae, Helicobacter pylori, herpes simplex virus, and cytomegalovirus and the risk for cardiovascular disease in women. Ann Intern Med. 1999 Oct 19;131(8):573-7.
Ridker PM, Manson JE, Buring JE, Shih J, Matias M, Hennekens CH. Homocysteine and risk of cardiovascular disease among postmenopausal women. JAMA. 1999 May 19;281(19):1817-21.
Ridker PM, Miletich JP, Buring JE, Ariyo AA, Price DT, Manson JE, Hill JA. Factor V Leiden mutation as a risk factor for recurrent pregnancy loss. Ann Intern Med. 1998 Jun 15;128(12 Pt 1):1000-3.
Hennekens CH, Lee IM, Cook NR, Hebert PR, Karlson EW, LaMotte F, Manson JE, Buring JE. Self-reported breast implants and connective-tissue diseases in female health professionals. A retrospective cohort study. JAMA. 1996 Feb 28;275(8):616-21. Erratum in: JAMA 1998 Jan 21;279(3):198.
Christen WG, Liu S, Schaumberg DA, Buring JE. Fruit and vegetable intake and the risk of cataract in women. Am J Clin Nutr. 2005 Jun;81(6):1417-22.
Kurth T, Slomke MA, Kase CS, Cook NR, Lee IM, Gaziano JM, Diener HC, Buring JE. Migraine, headache, and the risk of stroke in women: a prospective study. Neurology. 2005 Mar 22;64(6):1020-6.
Song Y, Ridker PM, Manson JE, Cook NR, Buring JE, Liu S. Magnesium intake, C-reactive protein, and the prevalence of metabolic syndrome in middle-aged and older U.S. women. Diabetes Care. 2005 Jun;28(6):1438-44.
Blake GJ, Pradhan AD, Manson JE, Williams GR, Buring J, Ridker PM, Glynn RJ. Hemoglobin A1c level and future cardiovascular events among women. Arch Intern Med. 2004 Apr 12;164(7):757-61.
Higginbotham S, Zhang ZF, Lee IM, Cook NR, Buring JE, Liu S. Dietary glycemic load and breast cancer risk in the Women's Health Study. Cancer Epidemiol Biomarkers Prev. 2004 Jan;13(1):65-70.
Higginbotham S, Zhang ZF, Lee IM, Cook NR, Giovannucci E, Buring JE, Liu S; Women's Health Study. Dietary glycemic load and risk of colorectal cancer in the Women's Health Study. J Natl Cancer Inst. 2004 Feb 4;96(3):229-33.
Liu S, Serdula M, Janket SJ, Cook NR, Sesso HD, Willett WC, Manson JE, Buring JE. A prospective study of fruit and vegetable intake and the risk of type 2 diabetes in women. Diabetes Care. 2004 Dec;27(12):2993-6. No abstract available.
Joffe HV, Ridker PM, Manson JE, Cook NR, Buring JE, Rexrode KM. Sex Hormone-Binding Globulin and Serum Testosterone are Inversely Associated with C-Reactive Protein Levels in Postmenopausal Women at High Risk for Cardiovascular Disease. Ann Epidemiol. 2005 Oct 6; [Epub ahead of print]
Song Y, Manson JE, Buring JE, Sesso HD, Liu S. Associations of dietary flavonoids with risk of type 2 diabetes, and markers of insulin resistance and systemic inflammation in women: a prospective study and cross-sectional analysis. J Am Coll Nutr. 2005 Oct;24(5):376-84.
Sesso HD, Buring JE, Chown MJ, Ridker PM, Gaziano JM. A prospective study of plasma lipid levels and hypertension in women. Arch Intern Med. 2005 Nov 14;165(20):2420-7.

Publications indexed to this study:
Karlson EW, Shadick NA, Cook NR, Buring JE, Lee IM. Vitamin E in the primary prevention of rheumatoid arthritis: the Women's Health Study. Arthritis Rheum. 2008 Nov 15;59(11):1589-95.
Pradhan AD, Cook NR, Manson JE, Ridker PM, Buring JE. A randomized trial of low-dose aspirin in the prevention of clinical type 2 diabetes in women. Diabetes Care. 2009 Jan;32(1):3-8. Epub 2008 Oct 3.
Kurth T, Schürks M, Logroscino G, Gaziano JM, Buring JE. Migraine, vascular risk, and cardiovascular events in women: prospective cohort study. BMJ. 2008 Aug 7;337:a636.
Suk Danik J, Rifai N, Buring JE, Ridker PM. Lipoprotein(a), hormone replacement therapy, and risk of future cardiovascular events. J Am Coll Cardiol. 2008 Jul 8;52(2):124-31.
Everett BM, Bansal S, Rifai N, Buring JE, Ridker PM. Interleukin-18 and the risk of future cardiovascular disease among initially healthy women. Atherosclerosis. 2009 Jan;202(1):282-8. Epub 2008 Apr 22.
Kurth T, Barr RG, Gaziano JM, Buring JE. Randomised aspirin assignment and risk of adult-onset asthma in the Women's Health Study. Thorax. 2008 Jun;63(6):514-8. Epub 2008 Mar 13.
Levitan EB, Liu S, Stampfer MJ, Cook NR, Rexrode KM, Ridker PM, Buring JE, Manson JE. HbA1c measured in stored erythrocytes and mortality rate among middle-aged and older women. Diabetologia. 2008 Feb;51(2):267-75. Epub 2007 Nov 28.
Glynn RJ, Ridker PM, Goldhaber SZ, Buring JE. Effect of low-dose aspirin on the occurrence of venous thromboembolism: a randomized trial. Ann Intern Med. 2007 Oct 16;147(8):525-33.
Conen D, Ridker PM, Buring JE, Glynn RJ. Risk of cardiovascular events among women with high normal blood pressure or blood pressure progression: prospective cohort study. BMJ. 2007 Sep 1;335(7617):432. Epub 2007 Aug 19.
Ding EL, Song Y, Manson JE, Rifai N, Buring JE, Liu S. Plasma sex steroid hormones and risk of developing type 2 diabetes in women: a prospective study. Diabetologia. 2007 Oct;50(10):2076-84. Epub 2007 Aug 14.
Zee RY, Mora S, Cheng S, Erlich HA, Lindpaintner K, Rifai N, Buring JE, Ridker PM. Homocysteine, 5,10-methylenetetrahydrofolate reductase 677C>T polymorphism, nutrient intake, and incident cardiovascular disease in 24,968 initially healthy women. Clin Chem. 2007 May;53(5):845-51. Epub 2007 Mar 1.
Kurth T, Everett BM, Buring JE, Kase CS, Ridker PM, Gaziano JM. Lipid levels and the risk of ischemic stroke in women. Neurology. 2007 Feb 20;68(8):556-62.
Everett BM, Kurth T, Buring JE, Ridker PM. The relative strength of C-reactive protein and lipid levels as determinants of ischemic stroke compared with coronary heart disease in women. J Am Coll Cardiol. 2006 Dec 5;48(11):2235-42. Epub 2006 Nov 13.
Mora S, Rifai N, Buring JE, Ridker PM. Additive value of immunoassay-measured fibrinogen and high-sensitivity C-reactive protein levels for predicting incident cardiovascular events. Circulation. 2006 Aug 1;114(5):381-7. Epub 2006 Jul 24.

Responsible Party: Brigham & Women's Hospital ( Julie Buring )
Study ID Numbers: 69, HL043851, CA047988
Study First Received: October 27, 1999
Last Updated: September 30, 2008
ClinicalTrials.gov Identifier: NCT00000479  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Arterial Occlusive Diseases
Tocopherol acetate
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Central Nervous System Diseases
Healthy
Ischemia
Arteriosclerosis
Brain Diseases
Cerebrovascular Disorders
Alpha-Tocopherol
Tocopherols
Coronary Disease
Vitamin E
Necrosis
Aspirin
Infarction
Myocardial Infarction
Coronary Artery Disease

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Pathologic Processes
Sensory System Agents
Therapeutic Uses
Vitamins
Anti-Inflammatory Agents, Non-Steroidal
Cardiovascular Diseases
Micronutrients
Analgesics
Growth Substances
Nervous System Diseases
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 30, 2009