Evolocumab treatment reduces carotid intima-media thickness in paediatric patients with heterozygous familial hypercholesterolaemia
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
Methodological detailsplacebo-controlled, post hoc inferential tests
- Placebo-controlled
- Post hoc inferential tests
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
| Outcome | Evolocumab | Placebo |
|---|---|---|
| Mean change in cIMT summary score · RCT baseline to OLE Week 80Inferential tests post hoc | mean decrease 0.012 (SD 0.05) mm · n = 59 | mean decrease 0.019 (SD 0.04) mm · n = 34 |
| P | P = 0.067 | 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.
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