Introduction: Low-density lipoprotein cholesterol (LDL-C) control as per 2019 ESC/EAS dyslipidaemia guidelines is a challenge in clinical practice. This prospective observational cohort study describes clinical characteristics and LDL-C control among patients initiating evolocumab across 12 EU countries; the German cohort is presented here.

Methods: Patient data were collected for ≤6 months prior to evolocumab initiation (baseline) and up to 30 months post initiation. Patient characteristics, lipid lowering therapy (LLT), lipid values, and evolocumab safety were collected from medical records.

Results: From the 1951 patients enrolled in the overall study, data from all 380 patients enrolled in Germany were included into this analysis (baseline Characteristics: Table 1). 92.9 % of the patients had an CV event before. The mean study follow-up for the German cohort was 18.4 months (SD 8.8). Median (Q1, Q3) baseline LDL-C was 145 mg/dl (113, 184). Within 3 months of initiation median LDL-C fell by 53% to 63 mg/dl. This reduction was maintained over time (Figure 1).  Among patients with non-missing post-baseline LDL-C data, 59.1% (217/367) achieved an LDL-C < 55 mg/dl and 73.3% (269/367) achieved an LDL-C < 70 mg/dl at any time after Repatha initiation. Overall, 84.8 % (95% CI 78.8, 89.4) of the patients who had received LLT at baseline achieved a 50 % LDL-C reduction versus baseline.  At evolocumab initiation and during follow-up (data summarised at 3-month intervals), background oral LLT did not materially change: 45-54% did not receive any statin or ezetimibe, 34-45% received statin ± ezetimibe, 14-18% received statin without ezetimibe. 

Conclusion: In Germany, patients treated with evolocumab presented with a mean baseline LDL-C of 145 mg/dl, this being almost 3 time higher than the threshold value recommended in guidelines. Although evolocumab led to a > 50% reduction in most of the patients in LDL-C sustained over the course of the study, only ~ 59% patients achieved an LDL-C < 55 mg/dl. LDL-C goal attainment was higher among patients receiving evolocumab with background LLT. The treatment data revealed that in many patients LLT prior to the onset of evolocumab was not intensified or there was no LLT at all. This might be explained by a high portion of patients with far distance to goal at baseline or with a statin intolerance, and hence, no statin at all or a low statin dose. Both circumstances present limitations to reach LDL-C targets.

Table 1 – Patient characteristics and background LLT at baseline:

LLT, lipid-lowering therapy, i.e. statin±ezetimibe

Fig 1:

n,the number of patients with a % change from baseline value