MRC/BHF Heart Protection Study of cholesterol-lowering therapy and of antioxidant vitamin supplementation in a wide range of patients at increased risk of coronary heart disease death: early safety and efficacy experience.

What this study found

The antioxidant vitamin regimen was well tolerated and produced the expected biochemical effect, but this early report mainly provides safety and biomarker data rather than clinical outcome results. Allocation to the vitamin supplement increased plasma vitamin E by about 24 mol/L versus about 25 mol/L on placebo capsules, and there was no significant difference in muscle symptoms, treatment discontinuation, or elevated liver and muscle enzymes during a mean 25 months of follow-up. The authors concluded that the treatment was safe and that the trial should provide reliable evidence on…

Study & population

Randomized, double-blind, placebo-controlled 2x2 factorial trial in men and women aged 40 to 80 years at increased risk of coronary heart disease death, including prior myocardial infarction or other coronary disease, occlusive arterial disease, diabetes, or treated hypertension.

Intervention

Antioxidant vitamin supplementation consisted of two capsules every evening containing vitamin E 600 mg, vitamin C 250 mg, and beta-carotene 20 mg daily, compared with matching placebo capsules, in a 2x2 factorial trial.

Key limitation

This was an early report with a mean follow-up of only 25 months, so definitive clinical efficacy outcomes were not yet available.

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