Elsevier

The Lancet

Volume 365, Issue 9473, 21–27 May 2005, Pages 1779-1785
The Lancet

Articles
Cost-effectiveness of simvastatin in people at different levels of vascular disease risk: economic analysis of a randomised trial in 20 536 individuals

https://doi.org/10.1016/S0140-6736(05)63014-0Get rights and content

Summary

Background

Statin therapy reduces the rates of heart attack, stroke, and revascularisation among a wide range of individuals. Reliable assessment of its cost-effectiveness in different circumstances is needed.

Methods

20 536 adults (aged 40–80 years) with vascular disease or diabetes were randomly allocated 40 mg simvastatin daily (10 269) or placebo (10 267) for an average of 5 years. Comparisons were made of hospitalisation and statin costs (2001 UK prices) during the scheduled treatment period between all simvastatin-allocated versus all placebo-allocated participants. Cost-effectiveness was estimated among different categories of participant.

Findings

Allocation to simvastatin was associated with a highly significant 22% (95% CI 16–27; p<0·0001) proportional reduction in hospitalisation costs for all vascular events, with similar proportional reductions in every subcategory of participant studied. During an average of 5 years, estimated absolute reductions in vascular event costs per person allocated 40 mg simvastatin daily ranged from UK£847 (SE 137) in the highest risk quintile studied to £264 (48) in the lowest. Mean excess cost of statin therapy among participants allocated simvastatin was £1497 (8), with similar absolute increases in every subcategory. Costs of preventing a major vascular event with 40 mg simvastatin daily ranged from £4500 (95% CI 2300–7400) among participants with a 42% 5-year major vascular event rate to £31 100 (22 900–42 500) among those with a 12% rate (corresponding to 5-year major coronary event rates of 22% and 4%, respectively).

Interpretation

Statin therapy is cost effective for a wider range of individuals with vascular disease or diabetes than previously recognised (particularly with lower-priced generics). It would be appropriate to consider reducing the estimated level of vascular event risk at which statin therapy is recommended.

Introduction

The MRC/BHF Heart Protection Study (HPS) has shown that lowering LDL cholesterol concentrations with 40 mg simvastatin daily produces substantial reductions in the rates of major vascular events (ie, heart attacks, strokes, and revascularisation procedures) among a wide range of high-risk individuals, irrespective of their pretreatment blood cholesterol concentrations.1, 2, 3, 4 Such treatment may, therefore, be cost effective for many types of high-risk patient who would not be prescribed statin therapy according to current guidelines.

The aim of this report is to estimate the cost-effectiveness of 40 mg simvastatin daily during the scheduled study treatment period among people at different underlying levels of risk for vascular events. This information should help determine appropriate risk thresholds for initiating statin therapy.

Section snippets

Methods

The perspective of these economic analyses is that of the UK National Health Service, and all costs are reported in UK£ for the year 2001 (ie, the year in which HPS ended).

Vascular and non-vascular events

Table 1 shows the risk of first major vascular event among HPS participants in univariate subgroups and multivariate risk quintiles, with the 5-year risk ranging widely from 42% in the highest risk quintile to 12% in the lowest. It also shows the 5-year risk of first major coronary event (ie, non-fatal myocardial infarction or coronary death), which is the outcome most commonly used as a basis for treatment guidelines, and the risk of vascular death. In previous HPS analyses,2, 3, 4 allocation

Discussion

The present analyses demonstrate clearly that the cost-effectiveness of statin therapy among a wide range of individuals with vascular disease or diabetes depends chiefly on their underlying risk of vascular events and the costs of statins. Previous analyses of HPS had involved intention-to-treat comparisons of all those allocated simvastatin versus all those allocated placebo. But, since an average of about a sixth of those allocated simvastatin stopped taking the study drug during the 5 year

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    Collaborators and participating hospitals listed at http://image.thelancet.com/extras/04art2126webappendix.pdf

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