Therapeutic strategies in the treatment of dyslipidemia in Germany

Background:
The treatment of hypercholesterolemia with lipid-lowering therapies (LLTs) commonly follows one of two treatment strategies: The "fire-and-forget" strategy (F&F) involves prescription of LLTs with a fixed dosage. The "treat-to-target" strategy (T2T) involves frequent monitoring of LDL-C levels and adjustment of LLTs dosage based on the patient's risk for cardiovascular events.

Purpose:
The purpose of the present analysis was to investigate the treatment strategies of incident patients with hypercholesterolemia and/or mixed dyslipidemia in Germany.

Methods:
The analysis involved incident patients with diagnosed hypercholesterolemia and/or mixed dyslipidemia in 2020 covered by German statutory health insurance. Descriptive analysis of four patient populations was conducted for one year after first diagnoses. We describe populations with and without LLTs, followed by stratification with respect to the observed treatment strategy (F&F or T2T). Patients with only one observable LDL-C measurement within 7 days before/after first diagnosis are categorized as being treated with F&F. T2T is defined as having at least two LDL-C measurements within the year after first diagnoses.

Results:
Of the 15,409 incident patients, 12,753 (83%) were not treated with LLTs within one year after diagnosis. The LLT population is older on average, has a lower proportion of women and shows a higher rate of comorbidities in the year prior to diagnosis compared to patients without LLT delivery. Notable comorbidities in the LLT group compared to those without LLT include hypertension (45% vs. 24%), depression (18% vs. 15%), obesity (14% vs. 10%), and diabetes mellitus (17% vs. 6%). Among the LLT population, 73% are assigned to the T2T subpopulation (n = 1,943) and 27% to the F&F subpopulation (n = 713). The average age and the proportion of women of the T2T and F&F subpopulation are comparable with the LLT population. The LDL-C value was measured in around 40% of the F&F subpopulation, with an average of 0.4 measurements per patient in the year after first diagnosis. In contrast, patients in the T2T population received 2.3 LDL-C measurements on average within the first year after diagnosis. A higher discontinuation rate of LLT treatment was observed in the F&F population (T2T: 62% vs. F&F: 72%). In both treatment strategies, up to 95% of patients were treated with LLT as monotherapy. Both groups had similar proportions of patients receiving cardiology care (T2T: 40% vs. F&F: 37%). Specialists in angiology, nephrology, and endocrinology were consulted infrequently (≤6%) in both groups. One third of both subpopulations were treated by general practitioners exclusively.

Conclusion(s):
Of the already low proportion of patients treated with lipid-lowering therapy within the first year after diagnosis of hypercholesterolemia and/or mixed dyslipidemia, the vast majority discontinued treatment (especially with monotherapy), suggesting a lack of effective LLT treatment. Adherence to LLT treatment and monitoring of LDL-C levels is of crucial importance to prevent cardiovascular events. Further investigation should investigate long-term patterns of LLT treatment strategies. 

Keywords: dyslipidemia, hypercholesterolemia, lipid-lowering therapy, fire-and-forget, treat-to-target