A One-Year Retrospective Observational Study Reveals the Transient Nature of Pemafibrate-Induced LDL-C Elevation: Implications Beyond the PROMINENT Trial.
📚 期刊: Drug design, development and therapy📅 发表: 0000-00-00🔬 PMID: 42445736🔗 DOI:10.2147/DDDT.S592050👁️ 浏览: 5
👤 作者: Iitake C, Iitake K
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Iitake C, Iitake K (0000). A One-Year Retrospective Observational Study Reveals the Transient Nature of Pemafibrate-Induced LDL-C Elevation: Implications Beyond the PROMINENT Trial.. Drug design, development and therapy. https://doi.org/10.2147/DDDT.S592050
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📝 摘要
PURPOSE: Pemafibrate, a selective peroxisome proliferator-activated receptor-α modulator (SPPARMα), is widely used for hypertriglyceridemia; however, concerns persist regarding its potential to elevate low-density lipoprotein cholesterol (LDL-C). Previous studies monitored LDL-C for only 3-6 months, leaving the long-term trajectory unclear. This one-year retrospective observational study aimed to determine whether pemafibrate-induced LDL-C elevation is sustained or transient and to identify factors associated with this response. PATIENTS AND METHODS: A total of 110 patients receiving pemafibrate (0.1-0.2 mg/day; standard dose 0.2 mg/day) were followed for one year. Serial lipid changes were analyzed, and predictors of LDL-C elevation were evaluated using multivariate regression. RESULTS: Triglyceride decreased markedly from 378.6 ± 248.7 to 191.5 ± 144.4 mg/dL (P < 0.001). LDL-C increased from 120.5 ± 30.6 to 129.7 ± 34.3 mg/dL at 3 months (P < 0.05), representing the peak of LDL-C elevation. Thereafter, LDL-C gradually declined and showed no statistically significant difference from the baseline at 12 months, demonstrating a characteristic transient "rise-and-return" pattern. Lower baseline LDL-C, lower HDL-C, and higher triglycerides were associated with greater LDL-C elevation, while statin use showed no significant association. Low baseline LDL-C was the strongest predictor in multivariate analysis. CONCLUSION: This study is the first to document the full one-year LDL-C trajectory under pemafibrate, revealing a transient "rise-and-return" pattern. LDL-C elevation peaks at approximately 3 months and returns to baseline by one year, indicating that the increase is temporary rather than persistent. These findings refine the understanding of pemafibrate's lipid effects and support its long-term safety profile. Pemafibrate is a medication used to lower high triglyceride levels. Some patients notice an increase in low-density lipoprotein cholesterol (LDL-C) after starting the drug, which can be worrying because LDL-C is often called “bad cholesterol.” Earlier studies followed patients for only 3 to 6 months, so it was unclear whether this rise continues or returns to normal. In this one-year study, we followed 110 patients taking pemafibrate. LDL-C increased during the first three months but then gradually decreased and returned to the original level by one year. This indicates that the LDL-C rise is temporary rather than permanent. Patients with low LDL-C, low HDL-C, and high triglycerides at the start were more likely to experience this temporary increase. These changes likely reflect how pemafibrate helps the body process fats more efficiently over time. Our findings suggest that the early rise in LDL-C is not harmful or permanent. Understanding this natural “rise-and-return” pattern can help clinicians use pemafibrate with confidence and avoid unnecessary concern about long-term cardiovascular risk.