Fenofibrate vs. Omega-3 in Pediatric Hypertriglyceridemia: A Randomized Controlled Trial
Abstract
Introduction: Concerning the growing prevalence of hypertriglyceridemia in pediatrics, further investigation into their use in children is warranted. This study aimed to evaluate the efficacy and safety of fenofibrate compared to omega-3 in pediatric hypertriglyceridemia.
Methods: This open-label, parallel-group randomized controlled trial was performed in 17 Shahrivar Hospital in Rasht, Iran, from January to June 2023. This included individuals aged 8 to 18 with TG levels >400 mg/dL or >250 mg/dL unresponsive to diet and exercise. Patients (N = 30) were randomly assigned to receive either fenofibrate (100 mg daily) or omega-3 (1,000 mg twice daily) for 12 weeks.
Results: Fenofibrate treatment significantly lowered triglyceride (TG), Low-density lipoprotein-cholesterol (LDL-C), and total cholesterol levels compared to omega-3 (p = .014, p < .001, and p < .001, respectively). The omega-3 group exhibited an upward trend in high-density lipoprotein-cholesterol (HDL-C) levels (p = .004), and intergroup differences were statistically significant (p = .038).
Discussion: Fenofibrate appeared to be a safe and effective candidate for TG lowering in pediatrics with hypertriglyceridemia, though further clinical research is recommended.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 30 participants or records.
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