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QUESTION: In patients with a high 5 year risk of death, does antioxidant supplementation reduce death, vascular events, and cancer?
Design
Randomised (allocation concealed*), blinded (participants, clinicians, data collectors, and outcome assessors),* placebo controlled trial with mean follow up of 5 years.
Setting
69 UK hospitals.
Patients
20 536 patients who were 40–80 years of age (28% were ≥ 70 y of age, 75% men); had nonfasting total cholesterol levels ≥3.5 mmol/l; and had a substantial 5 year risk of death because of a history of coronary heart disease (CHD), occlusive disease of noncoronary arteries, or diabetes mellitus or a history of treated hypertension (in men ≥65 y of age). Exclusion criteria included a clear indication for statin therapy according to the patient‘s doctor, abnormal liver or renal function, severe heart failure, severe chronic airway disease, cancer, and indication for high dose vitamin E supplements. Follow up was 99.7%.
Intervention
Patients received 2 months of active vitamins during a run …
Footnotes
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Sources of funding: UK Medical Research Council; British Heart Foundation; Merck & Co; Roche Vitamins.
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For correspondence: Heart Protection Study, Clinical Trial Service Unit, Radcliffe Infirmary, Oxford, UK. hps{at}ctsu.ox.ac.uk
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Abstract and commentary also published in ACP Journal Club