Prevention & lipidsSecondary analysis
Evolocumab treatment reduces carotid intima-media thickness in paediatric patients with heterozygous familial hypercholesterolaemia
- Secondary analysis of the HAUSER-RCT randomised trial and its open-label extension
- placebo-controlled
- post hoc inferential tests
Authors' conclusion
In children with HeFH, evolocumab plus statin treatment up to 104 weeks led to regression in carotid arterial wall thickening.
Study context
- Population
- Paediatric patients with FH (age 10–17 years) and LDL-C > 130 mg/dL despite statin therapy151 with evaluable carotid intima-media thickness (cIMT)
- Participants
- 157 patients
- Comparison
- Evolocumab vs placebo, then evolocumab open-label
- Evolocumabn = 76
- Placebon = 37reference
- Primary endpoint
- Change in cIMT (descriptive analysis a pre-specified secondary endpoint of HAUSER)
- Follow-up
- Week 24 of RCT
Primary result
As reported in the abstract
Mean change in cIMT · RCT baseline to Week 24
Placebo
0.006
mean increase · SD 0.05 · mm · n = 37
Evolocumab
0.003
mean decrease · SD 0.05 · mm · n = 76
Secondary outcomes
Mean change in cIMT summary score · RCT baseline to OLE Week 80 · inferential tests post hoc
P Evolocumab P = 0.067 · Placebo P = 0.007
- Mean change in cIMT summary score: Placebo = initially received placebo; Evolocumab = evolocumab throughout
Mean change in cIMT, all receiving evolocumab in open-label extension (OLE) · OLE Day 1 to Week 80
- Mean cIMT significantly decreased by 0.011 mm (SD = 0.05), n = 94
- P = 0.034
- post hoc
Original publication
Evolocumab treatment reduces carotid intima-media thickness in paediatric patients with heterozygous familial hypercholesterolaemia. Eur J Prev Cardiol. Published 12 November 2024. doi:10.1093/eurjpc/zwae369
Summarised from the published abstract; every number is checked against it