The Pharmaceutical Journal
Vol 269 No 7205 p4
6 July 2002

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The Lancet (www.thelancet.com)

Call for change to guidelines following publication of Heart Protection Study

Guidelines on the management of coronary heart disease should be changed so that a statin is considered for anybody at increased risk of heart attack or stroke regardless of their blood cholesterol level. This recommendation follows publication of the Heart Protection Study in The Lancet this week (2002;360:7).

"The clear message from this study is: 'Treat risk — not cholesterol level'," said Professor Sir Charles George, medical director of the British Heart Foundation.

Researchers from the Heart Protection Study collaborative group estimate that implementing the study findings, which were presented last November at the American Heart Association conference in Los Angeles (PJ, 17 November 2001, p701 and 24 November 2001, p740), would more than triple the number of people benefiting from statins and could save an extra 10,000 lives each year. In the United Kingdom, the number of people treated with statins would increase from a current figure of less than one in 20 of the population aged over 40 (or about one million people) to about one in eight (about three million people), they say.

In the study, 20,536 adults with coronary heart disease, arterial disease or diabetes were randomly assigned to receive either 40mg simvastatin or placebo daily for five years. Death from all causes occurred in 14.7 per cent of patients given placebo compared with 12.9 per cent of those given simvastatin (P=0.0003). This was mainly due to an 18 per cent relative reduction in the coronary death rate in patients assigned simvastatin (5.7 per cent versus 6.9 per cent, P=0.0005).

The National Service Framework for Coronary Heart Disease recommends that high risk patients — those with diagnosed coronary heart disease and those who are at a greater than 30 per cent risk of coronary heart disease over 10 years — should receive treatment with lipid-lowering drugs to reduce cholesterol levels to below 5mmol/L. However, the Heart Protection Study results suggest that there are substantial benefits among high-risk patients considered to have normal or low cholesterol levels.

Professor Rory Collins of the clinical trial service unit at Oxford University and lead investigator said: "HPS shows unequivocally that statins can produce substantial benefit in a very much wider range of high-risk people than had been thought." He added that it was not known how cost-effective implementing these findings would be. "We do recognise that the drug costs will be significant. But, we believe that the level of benefit in these high-risk patients is so great that treating them will be extremely cost-effective."

The researchers comment that most patients who would benefit from statins would already be known to their doctors because of their past medical history. Dr Jane Armitage, clinical co-ordinator for the study, said: "Implementing these findings does not require massive public health education campaigns by governments. It simply needs the guidelines to be changed so that doctors check their medical records and identify those patients with vascular disease or diabetes who we now know would benefit substantially from statin therapy."

The Heart Protection Study also assessed the effects of using antioxidant vitamin supplements (600mg vitamin E, 250mg vitamin C and 20mg beta-carotene daily) in people at high risk of vascular disease. Use of these supplements appeared to be safe and increased blood vitamin concentrations. However, they did not produce any significant reductions in the five-year risk of heart attacks, strokes, cancers or other major outcomes (ibid p23).