Efficacy of pemafibrate in patients with dyslipidemia: A systematic review and meta-analysis of randomized controlled trials
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This study aimed to evaluate the efficacy of pemafibrate in patients with hypertriglyceridemia compared to a placebo or fenofibrate through a rigorous systematic review process. To achieve this, we conducted comprehensive searches in the PubMed, Cochrane Library, and Embase databases. The data extraction process was based on published reports, and the assessment of study quality adhered to the PRISMA guidelines. A random-effects model was employed to calculate mean differences (MD) and 95% confidence intervals (CI). Statistical significance was established at P < 0.05, with I² values exceeding 25%, denoting a significant degree of heterogeneity. The primary outcomes of interest were MDs in triglycerides (TG) and non-high-density lipoprotein (HDL) cholesterol. The review protocol was registered with PROSPERO under the identifier CRD42022374852. Nine studies involving 12,644 patients were included, with 6699 (53%) patients receiving pemafibrate. The meta-analysis revealed a significant reduction in serum TG levels in the intervention group (0.4 mg/day) compared to the placebo group (MD: −48.29; 95% CI: −61.45 – −35.13; P < 0.0001; I² = 93%). Pemafibrate (0.4 mg/day) also led to significantly lower non-HDL cholesterol levels compared to control (MD: −6.35; 95% CI: −10.62 – −2.08; P < 0.0001; I² = 82%). There were no significant differences in TG reduction between pemafibrate (0.2 mg/day) and fenofibrate (200 mg/day) (MD: −2.90; 95% CI: −12.90 – 7.11; P = 0.003; I2 = 83%), or between pemafibrate (0.1 mg/day and 0.2 mg/day) and placebo (TG and non-HDL cholesterol levels). In conclusion, pemafibrate demonstrated efficacy in decreasing TG and non-HDL cholesterol levels for dyslipidemia patients, especially at a dosage of 0.4 mg/day compared to a placebo.
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