Evolocumab treatment reduces carotid intima-media thickness in paediatric patients with heterozygous familial hypercholesterolaemia
Bibliographic record
Abstract
AIMS: Children with heterozygous familial hypercholesterolaemia (HeFH) show greater carotid intima-media thickness (cIMT). Evolocumab, a proprotein convertase subtilisin/kexin type 9 inhibitor monoclonal antibody, substantially reduced LDL cholesterol (LDL-C) in children with HeFH. We investigated evolocumab's effect on cIMT progression. METHODS AND RESULTS: HAUSER-RCT was a randomized, placebo-controlled trial. One hundred fifty-seven paediatric patients with FH (age: 10-17 years) and LDL-C > 130 mg/dL despite statin therapy received monthly evolocumab 420 mg or placebo for 24 weeks. Patients who continued into an open-label extension (OLE) (HAUSER-OLE; n = 150) received 80 weeks of monthly evolocumab plus statins. Carotid intima-media thickness was measured by B-mode ultrasound scanning of right and left common carotid artery at baseline; Week 24 of randomized controlled trial (RCT) (Day 1 OLE); and Weeks 24, 48, and 80 of OLE. Descriptive analysis of cIMT was a pre-specified HAUSER secondary endpoint, and inferential tests reported here were post hoc. One hundred fifty-one patients had evaluable cIMT summary scores at ≥ 1 visit. From RCT baseline to Week 24, mean cIMT increased by 0.006 mm (SD = 0.05) with placebo (n = 37) and decreased by 0.003 mm (SD = 0.05) with evolocumab (n = 76). From RCT baseline to OLE Week 80, mean cIMT summary score decreased by 0.019 mm (SD = 0.04) and 0.012 mm (SD = 0.05), respectively, in patients who initially received placebo (n = 34, P = 0.007) vs. receiving evolocumab throughout (n = 59, P = 0.067). Across patients who received evolocumab in OLE, mean cIMT significantly decreased by 0.011 mm (SD = 0.05) from OLE Day 1 to Week 80 (n = 94, P = 0.034). CONCLUSION: In children with HeFH, evolocumab plus statin treatment up to 104 weeks led to regression in carotid arterial wall thickening. REGISTRATION: ClinicalTrials.gov: NCT02624869.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".