Background Hypercholesterolemia plays a causal role in the development of cardiovascular diseases. Patients are affected differently. There is a lack of epidemiological data about the frequence and characteristics of patients in Germany, especially about those who do not respond sufficiently to high intensity statins with or without other lipid modifying therapies. Methods From more than 2.6 million patient records of office based general practitioners, patients with hypercholestrolemia and high cardiovascular risk, who do not reach their individual LDL-C goal despite a best supplied twelve month maximum lipid lowering therapy (MPR ≥ 80 %), were extracted from the database. Results 5791 909 statutorily insured German patients are extrapolated with hypercholesterolemia (95 % CI: 5787 368 - 5796 454). 602 133 (95 % CI: 600 620 - 603 650) patients with high cardiovascular risk were treated with high intensity lipid modifying therapy (medication possession rate ≥ 80 %) for at least 1 year. 49 406 (95 % CI: 48 972 - 49 843) of them got mono-therapy with high intensity statins, 51 869 (95 % CI: 51 425 - 52 317) received statins in any dose combined with other lipid lowering drugs. 79 848 (95 % CI: 79 313 - 80 385) high risk patients did not reach LDL-C < 70 mg/dl despite optimal lipid treatment. 12 808 (95 % CI: 12 589 - 13 030) high risk patients even had LDL-C values ≥ 130 mg/dl. Discussion To classify patient's therapy refractory, they must have maximal drug therapy over a sufficient period of time. Usually statins are prescribed as first line therapy. Due to adverse events or contraindications statins are often prescribed in submaximal doses. Therefore patients with statins at lower dose combined with another lipid lowering drug were also included in the analysis. For patients missing the LDL-C target of ≤ 130 mg/dl despite optimal lipid lowering therapy there is a high medical need for innovative therapies.
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