Statin therapy is cost-effective for a wider range of individuals with vascular disease or diabetes than previously recognised

Statin therapy is cost-effective for a wider range of individuals with vascular disease or diabetes than previously recognised, concludes a study published online today by The Lancet.

Current guidelines generally recommend the initiation of statin therapy when the estimated 10-year risk of a non-fatal heart attack or coronary death is at least 15-20%.

The Heart Protection Study (HPS) has previously shown that lowering cholesterol concentrations with 40 mg of simvastatin daily produces substantial reductions not just in the rates of such coronary events, but also in the rates of strokes and revascularisation procedures among a wide-range of high-risk individuals, irrespective of their pre-treatment blood cholesterol concentrations.

In the HPS, over 20 500 adults aged 40-80 years with vascular disease or diabetes were randomly assigned to 40 mg of simvastatin daily or a placebo. In the latest study the HPS researchers compared the costs of hospitalisations and statin therapy between the two groups, and estimated the cost-effectiveness for participants with varying levels of vascular disease risk.

They found a 22% relative reduction in the costs of hospitalisations for vascular events in the statin group, with similar proportional reductions in every sub-category of patients studied. Overall, the cost of avoiding a major vascular event was estimated to be £11 600, but there was substantial variation between the risk subgroups. For example, among individuals with a 42% 5-year risk of a major vascular event, the estimated cost-effectiveness was £4 500 per major vascular event avoided. By contrast, among those with a 12% 5-year risk, it was estimated to be £31 100. The authors believe that initiation of statin therapy should now be considered for people at lower risk for coronary or other major vascular events than is currently recommended.

Professor Rory Collins (Clinical Trial Service Unit, University of Oxford, UK), principal investigator of HPS, concludes: “As simvastatin and other statins come to the end of their patent life, the fall in the drug cost should produce a corresponding improvement in the costeffectiveness of treatment. In the UK, the patent expired in May 2003, and the price of generic simvastatin has already fallen to about 15% of the 2001 proprietary price; as has also occurred elsewhere. At this price, the cost savings from reduced hospitalisations during the treatment period would outweigh the cost of 40 mg simvastatin daily for people with a 5-year major vascular event risk down to at least 12% - or, approximately equivalently, major coronary event risk of at least 4%. It now seems appropriate to consider reducing the estimated level of risk for major vascular events at which initiation of statin therapy is recommended.”

In an accompanying comment Kumiko Imai (US Centers for Disease Control and Prevention, USA) states: “Whilst the HPS study has shown that statin therapy decreases use of hospital resources, it is not clear how the therapy affects total use of health-care resources . . . Conducting economic evaluations alongside clinical trials is a viable means to evaluate health interventions. However, if such studies are to contribute to policy debates, it is important to generate information in a way that allows us to do what economic evaluations do best - to inform decision-making about resource allocation that maximises population health.”

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