Pharmacoeconomics of lipid-lowering agents for primary and secondary prevention of coronary artery disease

Cardiovascular disease is the leading cause of death and the leading source of healthcare expenditure in the US and most other industrialised countrie s. Cholesterol lowering by pharmacological means prevents atherosclerotic p laque progression and has been shown to reduce both fatal and nonfatal coro nary events in patients with or without coronary artery disease (CAD). Beca use of their excellent efficacy and safety profiles, the introduction of 3- hydroxy-3-methyl-glutaryl coenzyme A (HMG-CoA) reductase inhibitors (also k nown as 'statins') in 1987 raised hopes for demonstrating the survival bene fit of cholesterol reduction. In the past decade, several large-scale place bo-controlled trials with statin therapy have revisited the relationship be tween cholesterol reduction, cardiovascular disease and mortality. The West of Scotland Coronary Prevention Study (WOSCOPS) [pravastatin] and the Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS) [lov astatin] have shown significant cardiovascular disease reduction in primary prevention trials of patients with elevated and normal cholesterol levels, respectively. The Scandinavian Simvastatin Survival Study (4S), the Long-T erm Intervention with Pravastatin in Ischaemic Disease (LIPID) Study and th e Cholesterol and Recurrent Events (CARE) trial [pravastatin] have shown si gnificant cardiovascular disease reduction in patients with a previous hist ory of CAD with high, moderate and normal cholesterol levels, respectively. Three of these studies (4S, WOSCOPS and LIPID) have shown significant redu ction in all-cause mortality, while all the statin secondary prevention tri als (4S, CARE and LIPID) have demonstrated significant reduction in cerebro vascular disease/ Earlier cholesterol reduction cost-effectiveness studies with nonstatin tre atments (bile acid resins, fibrates, niacin and diet) suggested that only p atients at extremely high risk could be treated with lipid therapy in a cos t-effective manner. More recently, rigorous outcomes evidence demonstrates that statins, particularly for simvastatin for secondary prevention and lov astatin for primary prevention, have a broadly favourable cost-effectivenes s profile. Based on US medical price, levels and the available clinical tri al data on statins, it would be cost effective [e.g. cost less than $US50 0 00/year of life saved] to intervene with statin therapy in any patient with an annual CAD risk exceeding 1 %. This includes all patients with pre-exis ting CAD or diabetes mellitus, and many more primary prevention patients th an are currently contemplated by the US National Cholesterol Education Pane l treatment guidelines. Achieving such a goal will require enormous changes in patient education, clinical perspective, healthcare practice and health care finances. But any proven opportunity for saving the lives of 25% of th ose dying from cardiovascular disease each year deserves to be considered w ith the utmost seriousness and urgency.