Key result
Evolocumab decreased carotid intima-media thickness over 24 weeks in children with heterozygous familial hypercholesterolaemia, whereas it increased in those receiving placebo.
Why the study?
Does evolocumab reduce carotid intima-media thickness in pediatric patients with heterozygous familial hypercholesterolaemia on statin therapy?
RCT
Double-blind
randomized
Yes
Does evolocumab reduce carotid intima-media thickness in pediatric patients with heterozygous familial hypercholesterolaemia on statin therapy?
Answers are grounded in this paper and cite their sources.
Evolocumab added to statin therapy reduces carotid intima-media thickness, a surrogate marker for atherosclerosis, in pediatric patients with heterozygous familial hypercholesterolemia.
Wiegman et al.1 published in a recent issue a study titled, ‘Evolocumab treatment reduces carotid intima-media thickness in paediatric patients with heterozygous familial hypercholesterolaemia’. The authors investigated the effect of evolocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor monoclonal antibody on atherosclerosis in children with heterozygous familial hypercholesterolaemia (HeFH).1 As surrogate marker for pre-clinical atherosclerosis the carotid intima-media thickness (cIMT), measured by ultrasound, was used.1 In this multicentre, randomized, double-blind, placebo-controlled trial (RCT), children with HeFH (aged 10–17 years) with LDL-C levels above 130 mg/dL on lipid-lowering therapy (statins) received monthly subcutaneous injections of either evolocumab or placebo.1 Patients who continued into an open-label extension (OLE) study received 80 weeks of monthly open-label evolocumab plus statins.1 The cIMT was measured in one location, the common carotid artery (CCA) by B-mode ultrasound scanning at baseline, Week 24 of the RCT (=day 1 of the OLE) and at weeks 24, 48, and 80 of the OLE.1 The cIMT increased in patients who received placebo during the 24-week period, while it decreased in patients who received evolocumab.1 The study showed further that cIMT decreased in both groups, the evolocumab/evolocumab group and the placebo/evolocumab group during the 80-week period when all patients received evolocumab.
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Christian Saleh (2024) conducted an RCT in heterozygous familial hypercholesterolaemia (HeFH). Evolocumab vs. Placebo was evaluated on carotid intima-media thickness (cIMT). Evolocumab decreased carotid intima-media thickness over 24 weeks in children with heterozygous familial hypercholesterolaemia, whereas it increased in those receiving placebo.
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