Prevention & lipidsRandomised controlled trial
Evolocumab in paediatric heterozygous familial hypercholesterolaemia: cognitive function during 80 weeks of open-label extension treatment
- Open-label extension of the HAUSER-RCT randomised trial
- single-arm extension
Authors' conclusion
In paediatric patients with FH, 80 weeks of open-label evolocumab treatment had no negative impact on cognitive function.
Study context
- Population
- Paediatric patients (ages 10–17 years) with heterozygous familial hypercholesterolaemia (FH); all received monthly 420 mg subcutaneous evolocumab during the OLE
- Comparison
- Evolocumab over 80 weeks; prior placebo vs prior evolocumab in the RCT
- Primary endpoint
- Cognitive function (psychomotor function, attention, visual learning, executive function)
- Follow-up
- 80 weeks of OLE
Primary result
As reported in the abstract
Cognitive function · 80 weeks
No decrease in performance across visits for Groton Maze Learning, One Card Learning accuracy, Identification speed or Detection speed
all P > 0.05
Performance on all tasks similar for prior placebo vs evolocumab
all P > 0.05
LS mean differences between prior placebo vs evolocumab trivial
all Cohen's d magnitude < 0.2
Original publication
Evolocumab in paediatric heterozygous familial hypercholesterolaemia: cognitive function during 80 weeks of open-label extension treatment. Eur J Prev Cardiol. Published 19 October 2023. doi:10.1093/eurjpc/zwad332
Summarised from the published abstract; every number is checked against it