OBJECTIVES: Cardiovascular (CV) risk and diseases represent significant public health problem in Hungary. Rimonabant is the first in a new class of drugs called CB1-receptor-antagonists that improves multiple cardiometabolic risk factors such as waist circumference, HbA1c, HDL and TG in overweight/obese patients. The objective of our study is to assess the cost-effectiveness of rimonabant in the management of obese, or overweight patients with cardiometabolic risk factors, such as type 2 diabetes or dyslipidemia, in Hungary. METHODS: A Markov model was developed to assess the cost-effectiveness of rimonabant. Clinical outcomes were derived from RIO-Diabetes study and published equations were used to calculate the cardiovascular risks associated with obesity, and to determine the development of diabetes. Utilities applied in the model were primarily derived from the HODaR database. Hungarian direct costs at 2005 price level were calculated from database and questionnaires, using patient level resource use and cost data. The analysis was performed from the payer's perspective. The costs and outcomes were discounted at 5%/year. Deterministic and probabilistic sensitivity analyses were performed. RESULTS: Adding rimonabant to diet and exercise for 1 year is estimated to gain 56 QALYs for 1000 patients over lifetime. The savings resulting from CV events avoided could partly offset the cost of rimonabant, resulting incremental cost of €688 (169,132 HUF) per patient. One QALY costs €12,226 (3,004,735 HUF). Cost/QALY ratio after using RIO-Lipids in sensitivity analysis still remained acceptable in Hungary. CONCLUSION: Rimonabant, added to diet and exercise, can represent a cost-effective therapy compared to diet and exercise alone in the treatment of obese, or overweight patients with associated risk factor(s), such as type 2 diabetes or dyslipidaemia in Hungary