The NICE TA on statins confirms their clinical effectiveness in patients at risk of CVD. Dr Alan Begg discusses the evidence

Should all adults in England and Wales be taking a statin? Not at present is the conclusion of the NICE technology appraisal guidance on the use of statins for the prevention of cardiovascular events, published at the end of January.1

It does, however, recommend statins for all adults with evidence of cardiovascular disease (CVD) and for all those with a 10-year CVD event risk of ≥20%, in line with the JBS 2 guidelines.2

The recommendations are important because since January 2002, the NHS has been legally obliged to provide funding in England and Wales for medicines and treatments recommended by NICE technology appraisals.

The benefits of statins have been clearly demonstrated in placebo-controlled studies and to help the appraisal committee make their recommendations the assessment group from the School of Health and Related Research, University of Sheffield, examined 28 randomised controlled trials.

In their assessment they used the traditional distinction between those with clinically proven CVD (secondary prevention) and those with no clinical evidence of CVD (primary prevention). They concluded that with the use of statins there is a statistically significant reduction in the risk of:

  • all-cause mortality, fatal and non-fatal myocardial infarction (MI), and a composite endpoint of coronary heart disease (CHD) death plus non-fatal MI (in both primary and secondary prevention)
  • stable angina (in primary prevention)
  • cardiovascular mortality, CHD mortality, non-fatal stroke, peripheral arterial disease, unstable angina and coronary revascularisation (in secondary prevention).

No differentiation was possible in terms of relative risk between statin efficacy in primary and secondary prevention, but as the absolute risk of a CHD event is higher for secondary prevention there is more benefit in this group.

Apart from clinical effectiveness the committee felt that statin therapy was also cost-effective for the recommended groups.

This effectiveness was based on the prevention of clinical events rather than the surrogate endpoint of cholesterol lowering, and was dependent on the drug acquisition costs.

This contrasts with the available evidence which indicates that a lower LDL cholesterol, through intensive lipid lowering, will result in fewer CVD events.3

The analysis did suggest that it might be cost-effective to initiate statin therapy at a lower CVD 10-year risk threshold than 20% but this was not recommended because of the possible adverse effects that might become apparent when statins are used in lower risk populations for prolonged lifelong treatment.

No account has been taken of the likely additional staffing and costs that would occur, mainly in primary care, if patient identification and monitoring is to be done effectively to implement the guidance successfully.

It should also be noted that there is no randomised controlled trial evidence for the 10 mg OTC dose of simvastatin.

It is, however, essential that the use of statins is seen in conjunction with lifestyle changes as well as the use of other drugs to lower blood pressure and prevent vascular events.

  1. National Institute for Health and Care Excellence. Statins for the prevention of cardiovascular events. NICE Technology Appraisal 94. London: NICE, 2006. www.nice.org.uk
  2. JBS 2: Joint British Societies’ Guidelines on Prevention of Cardiovascular Disease in Clinical Practice. Heart 2005: 91(suppl v); v1-v52.
  3. Cannon CP.The IDEAL cholesterol: lower is better. JAMA 2005: 294(19); 2492-94.

Guidelines in Practice, February 2006, Volume 9(2)
© 2006 MGP Ltd
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