PCSK9 Inhibition with Evolocumab

PCSK9 inhibition with evolocumab reduces low-density lipoprotein cholesterol in adults and children with familial hypercholesterolaemia (FH). The HAUSER-RCT found that 24 weeks of treatment did not impact cognitive function in children.

Evolocumab treatment did not affect cognitive functions like learning, psychomotor function, executive function, and attention, says Dr. Raul D Santos, MD, PhD, in a recent study published in The European Journal of Preventive Cardiology.

HAUSER-OLE Study

HAUSER-OLE was an 80-week open-label extension of HAUSER-RCT. This randomized, double-blind, 24-week trial evaluated the efficacy and safety of evolocumab in children aged 10 to 17 years with FH. All patients received monthly subcutaneous injections of 420 mg of evolocumab. Psychomotor function, attention, visual learning, and executive function tests were administered at baseline and weeks 24 and 80 of the OLE. Descriptive analysis and ANCOVA analyzed changes over time, and Cohen’s d statistic was employed to determine the magnitude of treatment effects.

Key Findings from the Study

• ANCOVA results indicated no decrease in performance across visits during 80 weeks of evolocumab treatment for a computerized battery of cognitive tests, including Groton Maze Learning (executive function), One Card Learning accuracy (visual learning), Identification speed (visual attention), or Detection speed (psychomotor function).
• Performance on all tasks was similar for those who received placebo or evolocumab in the RCT.
• For all tests, the least square mean differences between patients taking placebo vs evolocumab were trivial (parent study).
• In this study, they tested whether treating children with evolocumab for 80 weeks affected their mental ability to perform several tasks. A battery of tests showed no decrease in performance across visits during 80 weeks of evolocumab treatment.

Reference

Raul D Santos et al. Evolocumab in paediatric heterozygous familial hypercholesterolaemia: cognitive function during 80 weeks of open-label extension treatment, European Journal of Preventive Cardiology, 2023; zwad332, https://doi.org/10.1093/eurjpc/zwad332