OBJECTIVES: Although hypercholesterolemia is a causal risk factor for cardiovascular diseases, currently there is a lack of epidemiological data on the number of high-risk patients who do not respond adequately to high-dose statin monotherapy or statin therapy in combination with other lipid-lowering agents in Germany.­­ METHODS: Of a total of over 2.6 million patient records from general practitioners (GPs) in the IMS Disease Analyzer database, all high-risk cardiovascular patients with hypercholesterol­emia who did not reach target LDL-C levels despite at least 12 months of maximum lipid-lowering therapy and optimal medication supply (MPR ≥ 80%) were selected over a defined period.­­­­­­ RESULTS:  On the basis of the practice data, a total of 602,133 patients with a high cardio­vascular risk who were treated with statin monotherapy or statin combination therapy with optimal medication supply (MPR ≥ 80%) for at least 12 months were identified by extra­polation. Of these, 49,406 patients received high-dose statin therapy and 51,869 patients received statin therapy in any dose in combination with another lipid-lowering agent. A total of 79,848 high-risk patients did not reach the target LDL-C level of ≤ 70 mg/dl despite con­sistent lipid-lowering therapy; of these, 12,808 had a documented LDL-C level ≥ 130 mg/dl.­­­­ CONCLUSIONS:  Patients who fail to reach the treatment goal despite receiving the maximum tolerated lipid-lowering therapy have a continued need for innovative lipid-lowering therapy alternatives.­­­