OBJECTIVE: The objective of this analysis is to assess the cost and quality of life of patients treated for hypercholesterolemia in Germany. METHODS: The following analysis uses the baseline data assessed at the beginning of the randomised controlled German ORBITAL study, designed to determine the impact of a compliance-enhancing program on long-term disease-related outcomes and costs. More than 8000 patients with hypercholesterolemia (HC) eligible for statin therapy have been enrolled. At baseline patients completed a detailed questionnaire. Health care resource use over the past 6 months, preceding enrolment, as well as quality of life (SF-12, EQ-5D and EQ-VAS) was assessed. RESULTS: A total of 2500 patients (mean age 61 ± 11 years, 44% female) were included in this analysis, 32% were employed at the time of inclusion, 19% had a history of myocardial infarction, 8% a history of stroke, 61% had hypertension and 28% diabetes. Disease-related direct costs amounted to a mean of €655 per patient in the six months period, indirect costs to €1495 per patient. Direct costs included mainly costs for hospital stays (€433), primary care consultations (€111), outpatient therapeutic measures (€54), and rehabilitation (€43). Indirect costs due to days off work amounted to €303, due to early retirement to €1191. Mean quality of life according to the EQ-5D was 0.81 (EQ-VAS 0.69). The mean scores of the SF-12 were 47.60 (PCS) and 43.24 (MCS). CONCLUSIONS: Indirect costs due to a loss of productivity contributed markedly to the disease-related costs in patients with HC. The considerable economic burden of HC indicates the need to assess long-term effectiveness of health care programmes in patients with the disorder.