MRC/BHF Heart Protection Study of Antioxidant Vitamin Supplementation in 20,536 High-risk Individuals: A Randomised Placebo-controlled Trial. - MRC/BHF Heart Protection Study of Antioxidant Vitamin Supplementation in 20,536 High-risk Individuals: A Randomised Placebo-controlled Trial.

Oct 31, 2002
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Date Presented:
01/01/2002
Date Published:
01/01/2002
Date Updated:
10/31/2002
Original Posted Date:
10/31/2002
References

Description:

Is there a value of vitamin supplements in persons at high risk for cardiovascular death?

Study Design

Study Design:

Drug/Procedures Used:

The British Heart Protection Study was a double blind placebo controlled 2 by 2 factorial study designed to assess the effects of simvastatin and a combination of antioxidant vitamins (600 mg of vitamin E, 250 mg of vitamin C, and 20 mg of beta-carotene daily) in patients at high risk for death in 5 years. High risk was defined as established coronary artery disease, peripheral vascular disease (PVD), diabetes, or treated hypertension in men over 65 years of age. The primary endpoint was the incidence of major coronary events.

Principal Findings:

20,536 individuals (5,082 women) were randomized and 5,806 were at least 70 years old. A previous MI was reported in 41%, other CAD in 24%, PVD in 20%, and approximately 15% of the patients were diabetics. Mean follow-up was 5.3 years. There was a significant increase in blood level of each of the vitamins in the actively treated subjects. There was no difference attributable to vitamins in all-cause mortality which occurred in 14%, deaths due to vascular or non-vascular causes, fatal or non-fatal MI, timing of first major vascular event, cancer, pulmonary function tests, fracture rate, cognitive impairment, psychiatric illness, or frequency of hospitalization.

Interpretation:

Among persons at high risk for CV death, administration of these antioxidants were not associated with any significant reduction in 5 year mortality from or incidence of any type of vascular disease, cancer, or other major outcome. In a separate report in the same journal Lancet, simvastatin in contrast was associated with an approximate 25% reduction in all major cardiovascular outcomes. The benefit attributable to simvastatin was independent of the baseline lipid values including a baseline LDL-C < 100mg/dl. There was no benefit of antioxidants alone or in combination with the statin. While vitamin supplements were demonstrated to be safe in this study, this is in contrast to a recent study (HATS) in which vitamin E supplements decreased the clinical and coronary angiographic benefit of the combination of niacin and simvastatin, apparently by decreasing the protective HDL fraction.

References:

Heart Protection Study Collaborative Group. MRC/BHF Heart Protection Study of Antioxidant Vitamin Supplementation in 20,536 High-risk Individuals: A Randomised Placebo-controlled Trial. Lancet 2002;360:23-33.

Keywords: Coronary Artery Disease, Cognition, Neoplasms, Follow-Up Studies, Vitamin E, beta Carotene, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Lipids, Simvastatin, Respiratory Function Tests, Peripheral Vascular Diseases, Coronary Angiography, Dietary Supplements, Niacin, Hypertension, Diabetes Mellitus


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