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Evolocumab-Based LDL-C Management in High and Very High Cardiovascular Risk Patients in German Clinical Practice: The
Michael Lehrke1, Anja Vogt2, Volker Schettler3
1Department of Internal Medicine I, University Hospital RWTH Aachen, Pauwelsstraße 30, 52074, Aachen, Germany. Michael.Lehrke@kliniken-sob.de.
Insights
Evolocumab significantly reduced LDL cholesterol in high-risk patients, with 59% reaching the <55 mg/dL goal. High persistence and safety were observed, especially when combined with other lipid-lowering therapies.
Area of Science:
- Cardiology
- Pharmacology
- Public Health
Background:
- Low-density lipoprotein cholesterol (LDL-C) is a key modifiable risk factor for cardiovascular disease.
- European guidelines recommend LDL-C <55 mg/dL for very high-risk patients.
- The HEYMANS study investigated evolocumab's use in a German cohort.
Purpose of the Study:
- To describe clinical characteristics of patients initiating evolocumab.
- To assess LDL-C control in these patients.
- To evaluate evolocumab's effectiveness and safety in real-world practice.
Main Methods:
- Observational study of 380 patients in Germany.
- Data collected retrospectively (up to 6 months pre-initiation) and prospectively (up to 30 months post-initiation).
- Collected data included patient characteristics, lipid-lowering therapy (LLT), lipid values, and safety.
Main Results:
- Evolocumab initiation led to a median 53% LDL-C reduction within 3 months, sustained long-term.
- 59% of patients achieved the LDL-C goal (<55 mg/dL), with higher rates (69%) when combined with LLT.
- High persistence (90.6% at 1 year, 93.5% at 2.5 years) and a favorable safety profile (8% adverse drug reactions) were noted.
Conclusions:
- Evolocumab effectively and safely reduces LDL-C in clinical practice, corroborating prior findings.
- Rapid and sustained LDL-C lowering was observed, with high patient persistence.
- Combination therapy with evolocumab and LLT enhances achievement of LDL-C goals, underscoring the importance of intensive treatment strategies.
Introduction:
Low-density lipoprotein cholesterol (LDL-C) is among the most important modifiable risk factors for cardiovascular disease. In very high-risk patients, the European Society of Cardiology/European Atherosclerosis Society guidelines recommend attaining LDL-C < 55 mg/dL. In the German cohort of the observational HEYMANS study, we aimed to describe the clinical characteristics and LDL-C control among patients initiating evolocumab.
Methods:
Data was collected between 09/2016 and 05/2021 for ≤ 6 months before (retrospectively) and ≤ 30 months after evolocumab initiation (prospectively). Patient characteristics, lipid-lowering therapy (LLT), lipid values, evolocumab use, and safety were collected.
Results:
Of 380 enrolled patients, 93% received evolocumab in secondary prevention and 69% had a history of statin intolerance. At study baseline, 49% did not receive any statins and LDL-C was very high (145 mg/dL). Use of evolocumab decreased LDL-C by a median of 53% within 3 months and remained stable thereafter, despite mainly unchanged background LLT. Overall, 59% attained an LDL-C level < 55 mg/dL (69% with, 49% without LLT). Persistence to evolocumab was 90.6% in months 1-12 and 93.5% in months 13-30. Adverse drug reactions were reported in 8% of patients.
Conclusion:
Data from the German HEYMANS cohort corroborate previous reports on evolocumab effectiveness and safety in clinical practice. Evolocumab initiation was associated with a rapid and sustained LDL-C reduction. Persistence with evolocumab was high. Our finding that patients receiving an evolocumab/LLT combination are more likely to attain the LDL-C goal than those receiving evolocumab alone corroborates previous data showing the importance of using highly intensive therapy. Graphical abstract available for this article.
Trial Registration:
ClinicalTrials.gov Identifier NCT02770131 (registration date 27 April 2016).
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