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Vitamin E Did Not Prevent Cardiovascular Disease and Cancer in Healthy Women

Posted on: Thursday, 26 January 2006, 09:00 CST

By Lee, I M; Cook, N R; Gaziano, J M

Vitamin E did not prevent cardiovascular disease and cancer in healthy women

Lee IM, Cook NR, Gaziano JM, et al. Vitamin E in the primary prevention of cardiovascular disease and cancer. The Women's Health Study: a randomized controlled trial. JAMA. 2005;294:56-65.

Clinical impact ratings: GIM/FP/GP ******* Hospitalists *******

QUESTION

In healthy women ≥ 45 years of age, how effective is vitamin E in preventing cardiovascular disease (CVD) and cancer?

METHODS

Design: Randomized placebo-controlled trial (Women's Health Study [WHS], a randomized 2 2 factorial trial).

Allocation: Concealed.*

Blinding: Blinded {participants, health care providers, data collectors, and outcome assessors}[dagger].*

Follow-up period: Mean 10.1 years.

Setting: {A mail-based trial in female health professionals in die United States}[dagger]

Participants: 39 876 women ≥ 45 years of age (mean age 55 y) without a history of cancer (except nonmelanoma skin cancer), CVD, or other major chronic illness; no history of adverse effects to aspirin; and not taking aspirin or nonsteroidal antiinflammatory drugs > once per week; anticoagulants or corticosteroids; or individual supplements of vitamin A, vitamin E, or β-carotene > once per week.

Intervention: Vitamin E (600 IU of α- tocopherol every other d) (n = 19 937) or matching placebo (n = 19 939).

Outcomes: A composite endpoint of first major CV event (nonfatal myocardial infarction [MI], stroke, or CV death), and total invasive cancer excluding nonmelanoma skin cancer. secondary outcomes were individual CV events and main site-specific types of cancer (breast, lung, and colon).

Patient follow-up: 97% for morbidity and 99% for mortality (intention-to-treat analysis).

MAIN RESULTS

Vitamin E did not reduce the composite endpoint of first major CV event and did not reduce total invasive cancer more than placebo (Table). Vitamin E also did not reduce MI (relative risk [RR] 1.01, 95% CI 0.82 to 1.23), stroke (RR 0.98, CI 0.82 to 1.17), or main site-specific types of cancer (breast RR 1.00, CI 0.90 to 1.12; lung RR 1.09, CI 0.83 to 1.44; colon RR 1.00, CI 0.77 to 1.31). Vitamin E reduced CV death more than placebo (0.5% vs 0.7%; RR 0.76, CI 0.59 to 0.98).

Vitamin E vs placebo to prevent cardiovascular disease (CVD) and cancer at mean 10.1 years[double dagger]

CONCLUSION

In healthy women ≥ 45 years of age, vitamin E did not prevent CVD and cancer.

Sources of funding: National Heart, Lung, and Blood Institute and National Cancer Institute.

For correspondence: Dr. LM. Lee, Brigham and Women's Hospital, Boston, MA, USA. E-mail ilee@rics.bwh.harvard.edu.

* See Glossary.

[dagger] Information provided by author.

Copyright American College of Physicians Jan/Feb 2006

Source: ACP Journal Club

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