Shift in therapeutic approaches in patients with hypercholesterolemia - a secondary data analysis.

Background: Atherosclerotic cardiovascular disease is a leading cause of death and hypercholesterolemia is one relevant risk factor. There are two established guidelines for the management of high cholesterol in general practice in Germany, one of these is from the European Society of Cardiology (ESC). This analysis examines whether treatment modalities and clinical outcomes in German primary care have changed after the publication of the 2019 ESC (European Society of Cardiology)/EAS (European Atherosclerosis Society) guidelines on dyslipidaemia.

Methods: A retrospective cohort study (2001-2023) with data extracted from electronic health record systems of 17 primary care practices. The Data was used to compare drug treatment and outcomes before and after 2019, the year of the ESC guideline publication. Multilevel regression analysis was used to assess the effects of the new guidelines, accounting for time trends and patient- and practice-level factors.

Results: Statin prescriptions for 23,322 patients with hypercholesterolemia increased from 6% in 2001 to 27% in 2023, with an increase in treatment intensity after 2012. Despite general reductions in total and LDL cholesterol, cardiovascular events remained unchanged, while reported complaints associated with side effects increased. Multilevel regression showed more prescriptions after the new ESC/EAS guidelines, with no effect on treatment intensity or outcomes.

Conclusion: Following the publication of the new ESC/EAS guideline, a modest rise in statin prescriptions has been documented. However, despite improved lipid profiles, clinically relevant events did not decrease yet, and side effects increased, questioning the benefit of tailoring statin therapy to lower lipid thresholds in real world data so far.

Trial registration: German Clinical Trials Register: DRKS00032936. Registration Date: October 30, 2023.