A 2-year randomized trial of pitavastatin calcium vs placebo to treat combined dyslipidemia in adolescents with overweight and obesity

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BACKGROUND: Combined dyslipidemia of overweight/obesity (CDO) is prevalent in youth and is associated with an increased risk of early cardiovascular disease. OBJECTIVE: We sought to determine the impact and safety of statin therapy for CDO in adolescents. METHODS: A double-blind, randomized trial was performed across 18 North American sites. Participants aged 10 to 19 years with body mass index ≥85th percentile and CDO defined as non-high-density lipoprotein cholesterol (non-HDL-C) ≥120 mg/dL (3.10 mmol/L) and either low HDL-C or high triglyceride:HDL-C ratio were randomized centrally to receive either pitavastatin calcium 4 mg/d or placebo for 2 years. The primary outcome was change in carotid-femoral pulse wave velocity (PWV), assessed at baseline, 6, 12, 18, and 24 months. Secondary outcomes included safety and lipid measures. RESULTS: The intention-to-treat analysis included 59 participants (33 males) who received pitavastatin calcium and 60 who received placebo (32 males), enrolled from June 2018 to April 2021. There were no significant changes or trends for PWV in either group. Compared with placebo, at 24 months, pitavastatin was associated with significantly reduced low-density lipoprotein cholesterol (from 134 ± 23 mg/dL [3.47 ± 0.60 mmol/L] to 105 ± 25 mg/dL [2.72 ± 0.65 mmol/L] pitavastatin vs 130 ± 25 mg/dL [3.37 ± 0.65 mmol/L] to 126 ± 27 mg/dL [3.26 ± 0.70 mmol/L] placebo; P < .001). There was 1 serious adverse event (placebo), and no significant differences in liver enzymes, muscle toxicity, glucose homeostasis, or linear growth. CONCLUSION: Over 2 years, treatment with pitavastatin calcium of CDO for adolescents resulted in no changes in vascular measures. Statin therapy safely lowered atherogenic lipid particles, potentially reducing cardiovascular risk.

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