OBJECTIVES: Atherosclerosis is a disease with relevant epidemiologic and economic consquences; in 1999, 260.000 atherosclerosis-related hospitalizations occurred in Italy. There is evidence that Amlodipine treatment is effective in reducing the health burden of atherosclerosis and the objective of this analysis is to assess the pharmacoeconomic profile of Amlodipine in atherosclerotic disease and in the Italian scenario. METHODS: Alternatives: standard care plus Amlodipine besylate treatment vs standard care alone in patients with CAD identified by angiography in Italy. Perspective: National Health Service (NHS). Technique: cost-effectiveness analysis on 2 hypothetical cohorts of 1000 subjects; an incremental cost per patient free for events has been calculated. Time: 36 months. All effects and costs were discounted with an annual rate of 5%. Costs: drugs and direct medical costs quantified by using NHS tariffs expressed in € 2002. Effects: measured through the results from the PREVENT study (Pitt B et al, 2000): i.e. fatal acute myocardial infarction (AMI) or not, fatal stroke or not, congestive heart failure, unstable angina, CABG and PTCA. RESULTS: Treating the hypotethical cohort of 1000 subjects with Amlodipine resulted in a total cost of €2.896.345 (€1.267.472 for pharmacological treatment and €1.628.873 for treating 355 events). Treating the hypotethical cohort of 1000 subjects with placebo resulted in a total cost of €2.643.732 to follow 547 events. The treatment with Amlodipine was superior regarding the development of any first event (206 with Amlodipine and 284 with placebo) and the incremental cost per patient free for events was €3.235. CONCLUSIONS: The results indicate that Amlodipine therapy is more effective and more costly than placebo and that a drug investment with Amlodipine leads to a significant reduction of the health burden of atherosclerotic disease. The incremental health benefit can be obtained at an affordable cost.