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BMJ No 7122 Volume 315 Letters Saturday 13 December 1997 Use of statins See Editorial by Muldoon p1554 Cost effectiveness was studied in 4S study Editor Freemantle et al criticise the recommendations from the Standing Medical Advisory Committee on the use of statins to prevent coronary artery disease because due attention is not paid to the link between cost and benefits.(1) Some of their statements concerning the Scandinavian simvastatin survival study (4S) are biased and require comment. The 4S had sufficient power to avoid bias in the final estimate of efficacy.(2) The data and safety monitoring committee recommended that the trial be stopped because of overwhelming benefit in favour of the active treatment group when the number of deaths was 438, close to the 440 deaths expected for the completed trial. The narrow confidence intervals indicated a high validity in the result. Thus the statement that the early ending of the trial was data driven and so may have overestimated the effects is unreasonable. The authors' table showing numbers of patients who died or had myocardial infarction gives only the number admitted to hospital with confirmed infarction; patients with probable myocardial infarction, silent myocardial infarction, and infarction associated with an intervention are omitted. For patients and for economic evaluation, any major coronary event leading to admission will be equally important. In 4S the reduction in absolute risk for such events with simvastatin is 6.2%, or if all coronary events are considered 6.7%, not 4.8%. The table therefore underestimates the full impact of the disease and the benefit of treatment. The benefits continue to accrue the longer the treatment is given, and the number of lives saved over five years is likely to underestimate the long term benefit of this treatment in clinical practice. The reduction in absolute risk depends on risk, and patients whose low density lipoprotein cholesterol concentrations are low have less benefit in absolute terms than patients with high concentrations. Freemantle et al therefore demand evidence on benefits and costs for these groups of patients. Three reports on cost minimisation and cost effectiveness have been published from 4S,(3-5) showing that simvastatin is highly cost effective by reducing days in hospital and need for revascularisation, for all cholesterol concentrations studied. The cost effectiveness of simvastatin compares with that of bypass surgery for main stem and three vessel disease but is far greater than that of bypass surgery for two vessel disease. If indirect costs (for example, greater productivity because the patients stays healthy longer) is included in the analysis the treatment is cost saving in younger patients.(5) For patients with the 4S criteria, information on cost effectiveness exists and the data are more encouraging than the editorial suggests. John Kjekshus Chairman of steering committee for 4S Department of Medicine B, University of Oslo, Rikshospitalet, Oslo, Norway Terje R Pedersen Coordinator for 4S Department of Medicine, University of Oslo, Aker Hospital, Oslo References 1 Freemantle N, Barbour R, Johnson R, Marchment M, Kennedy A. The use of statins: a case of misleading priorities? BMJ 1997;315:826-8. (4 October.) 2 Scandinavian Simvastatin Survival Study Group. Randomised trial of cholesterol lowering in 4,444 patients with coronary heart disease: the Scandinavian simvastatin survival study (4S). Lancet 1994;344:1383-9. 3 Pedersen T R, Kjekshus J K, Berg K, Olsson A G, Wilhelmsen L, Wedel H, et al. Cholesterol lowering and the use of the health care resources: results of the Scandinavian simvastatin survival study. Circulation 1996;93:1796-802. 4 Jonsson B, Johannesson M, Kjekshus J, Olsson A G, Pedersen T R, Wedel H. Cost-effectiveness of cholesterol lowering: results from the Scandinavian simvastatin survival study (4S). Eur Heart J 1996;17:1001-7. 5 Johannesson M, Jonsson B, Kjekshus J, Olsson A G, Pedersen T R, Wedel H. Cost-effectiveness of simvastatin treatment to lower cholesterol levels in patients with coronary heart disease. N Engl J Med 1997;336:332-6. Home | Current issue | Past issues | Classified ads | Career Focus | Feedback Collections | About this site | About the BMJ | BMA | Medline