Abstract MP60: A Randomized Placebo-Controlled Trial of Pitavastatin Calcium to Treat Combined Dyslipidemia of Obesity in Adolescents - The Pediatric Heart Network Dyslipidemia of Obesity Intervention in Teens (Do It!) Trial
Bibliographic record
Abstract
Background: Combined dyslipidemia of obesity (CDO) is prevalent in ~20% of youth and characterized by high numbers of atherogenic small LDL (sLDL) particles associated with stiffer arteries. The safety and impact of statin therapy is not known. Methods: A 2-year masked trial of pitavastatin calcium 4 mg/day versus placebo for participants ages 10-19 years with body mass index (BMI) ≥85 th %ile and CDO defined as non-HDL-C ≥120 mg/dL and either low HDL-C or high triglyceride (TG):HDL-C ratio. The primary outcome was change in carotid-femoral pulse wave velocity (PWV) and carotid measures assessed at baseline, 6, 12, 18, and 24 months. Secondary outcomes included safety and lipid measures. Results: Across 18 sites, 59 participants were randomized to pitavastatin and 60 to placebo. Demographic (mean age 13.5±1.2 yrs; 55% males), anthropomorphic (BMI %ile 98±3; waist/height ratio 0.66±0.08), lipid (non-HDL-C 167±29 mg/dL, LDL-C 127±25 mg/dL, HDL-C 37±7 mg/dL, TG/HDL ratio 6.4±4.7, sLDL number 866±419 nmol/L), vascular (PWV 5.0±0.7 m/sec) and safety measures were similar at baseline between groups. There were 28 early terminations (11 pitavastatin, 17 placebo). Significant reductions with pitavastatin versus placebo were noted in non-HDL-C (median -25% vs +3% at 6 months, p<0.001), LDL-C (-29% vs +7%, p<0.001), and apolipoprotein B (-26% vs 0%, p<0.001). An early reduction relative to placebo in sLDL particle number was not sustained (FIGURE A), and there were no significant changes or trends for PWV (FIGURE B) or carotid measures in either group. There was one serious adverse event (placebo), and no significant differences in liver enzymes, muscle toxicity, glucose homeostasis, or somatic growth, including adiposity. Conclusions: Over 2 years, treatment of CDO in adolescents with pitavastatin calcium resulted in significant improvement in dyslipidemia with no safety concerns. No change in PWV in either group may be due to lower-than-expected baseline PWV, insufficient magnitude of impact on CDO, or lack of change in adiposity.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.013 | 0.001 |
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 source (direct Gemma or distilled Codex), 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".