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The Women's Antioxidant Cardiovascular Study: design and baseline characteristics of participants.
J Womens Health (Larchmt) 2004 Jan-Feb; 13(1):99-117JW

Abstract

BACKGROUND

The evidence for a potential benefit of antioxidant vitamins and folic acid in cardiovascular disease (CVD) prevention is derived from laboratory, clinical, and observational epidemiological studies but remains inconclusive. Large-scale randomized trials with clinical end points are necessary to minimize confounding and provide unbiased estimates of the balance of benefits and risks, yet data from such trials are scarce, especially among women.

METHODS

The Women's Antioxidant Cardiovascular Study (WACS) is a randomized, double-blind, placebo-controlled trial testing whether antioxidant vitamins and a folic acid/vitamin B(6)/vitamin B(12) combination prevent future cardiovascular events among women with preexisting CVD or >or=3 CVD risk factors. This paper describes the design of the trial and baseline characteristics of participants, evaluates the success of randomization, and addresses the generalizability of future findings.

RESULTS

In a factorial design, 8171 U.S. female health professionals aged >or=40 years were randomized to vitamin E, vitamin C, beta-carotene, or placebos. Of these women, 5442 were also subsequently randomized to folic acid/vitamin B(6)/vitamin B(12) or placebo. The randomization was successful, as evidenced by similar distributions of baseline demographic, health, and behavioral characteristics across treatment groups. The clinical profile of participants was similar to that observed in another large trial of women with CVD.

CONCLUSIONS

The similar distribution of known potential confounders across treatment groups provides reassurance that unmeasured or unknown potential confounders are also equally distributed. Although a definitive conclusion regarding generalizability requires additional trials in diverse populations, there is little biological basis for supposing that the benefit-risk balance differs in other high-risk women.

Authors+Show Affiliations

Division of Preventive Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02215, USA. sbassuk@rics.bwh.harvard.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

15006283

Citation

Bassuk, Shari S., et al. "The Women's Antioxidant Cardiovascular Study: Design and Baseline Characteristics of Participants." Journal of Women's Health (2002), vol. 13, no. 1, 2004, pp. 99-117.
Bassuk SS, Albert CM, Cook NR, et al. The Women's Antioxidant Cardiovascular Study: design and baseline characteristics of participants. J Womens Health (Larchmt). 2004;13(1):99-117.
Bassuk, S. S., Albert, C. M., Cook, N. R., Zaharris, E., MacFadyen, J. G., Danielson, E., ... Manson, J. E. (2004). The Women's Antioxidant Cardiovascular Study: design and baseline characteristics of participants. Journal of Women's Health (2002), 13(1), pp. 99-117.
Bassuk SS, et al. The Women's Antioxidant Cardiovascular Study: Design and Baseline Characteristics of Participants. J Womens Health (Larchmt). 2004;13(1):99-117. PubMed PMID: 15006283.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The Women's Antioxidant Cardiovascular Study: design and baseline characteristics of participants. AU - Bassuk,Shari S, AU - Albert,Christine M, AU - Cook,Nancy R, AU - Zaharris,Elaine, AU - MacFadyen,Jean G, AU - Danielson,Eleanor, AU - Van Denburgh,Martin, AU - Buring,Julie E, AU - Manson,Joann E, PY - 2004/3/10/pubmed PY - 2004/5/27/medline PY - 2004/3/10/entrez SP - 99 EP - 117 JF - Journal of women's health (2002) JO - J Womens Health (Larchmt) VL - 13 IS - 1 N2 - BACKGROUND: The evidence for a potential benefit of antioxidant vitamins and folic acid in cardiovascular disease (CVD) prevention is derived from laboratory, clinical, and observational epidemiological studies but remains inconclusive. Large-scale randomized trials with clinical end points are necessary to minimize confounding and provide unbiased estimates of the balance of benefits and risks, yet data from such trials are scarce, especially among women. METHODS: The Women's Antioxidant Cardiovascular Study (WACS) is a randomized, double-blind, placebo-controlled trial testing whether antioxidant vitamins and a folic acid/vitamin B(6)/vitamin B(12) combination prevent future cardiovascular events among women with preexisting CVD or >or=3 CVD risk factors. This paper describes the design of the trial and baseline characteristics of participants, evaluates the success of randomization, and addresses the generalizability of future findings. RESULTS: In a factorial design, 8171 U.S. female health professionals aged >or=40 years were randomized to vitamin E, vitamin C, beta-carotene, or placebos. Of these women, 5442 were also subsequently randomized to folic acid/vitamin B(6)/vitamin B(12) or placebo. The randomization was successful, as evidenced by similar distributions of baseline demographic, health, and behavioral characteristics across treatment groups. The clinical profile of participants was similar to that observed in another large trial of women with CVD. CONCLUSIONS: The similar distribution of known potential confounders across treatment groups provides reassurance that unmeasured or unknown potential confounders are also equally distributed. Although a definitive conclusion regarding generalizability requires additional trials in diverse populations, there is little biological basis for supposing that the benefit-risk balance differs in other high-risk women. SN - 1540-9996 UR - https://www.unboundmedicine.com/medline/citation/15006283/The_Women's_Antioxidant_Cardiovascular_Study:_design_and_baseline_characteristics_of_participants_ L2 - https://www.liebertpub.com/doi/full/10.1089/154099904322836519?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -