Hida Yuki, Imamura Teruhiko, Kinugawa Koichiro
The Second Department of Internal Medicine, University of Toyama, 2630 Sugitani, Toyama 930-0194, Japan.
J Clin Med. 2024 Oct 2;13(19):5879. doi: 10.3390/jcm13195879.
Pemafibrate is a novel selective peroxisome proliferator-activated receptor-α modulator, which was demonstrated to reduce serum triglyceride levels with few drug-related adverse events in several clinical studies, as well as phase II and III clinical trials. One of the limitations of this medicine was the requirement of twice-daily oral administration, resulting in reduced medication adherence, particularly in elderly patients, who are rather good targets for this medicine. Recently, a once-daily extended-release (XR) tablet has been introduced. Given an improvement in medication adherence, the therapeutic efficacy of pemafibrate may be enhanced. Patients with hypertriglyceridemia, in whom conventional twice-daily immediate-release (IR) pemafibrate was converted to pemafibrate XR between 2023 and 2024, were eligible. Each type of tablet was prescribed for three months, respectively. A dose change was not attempted. The serum triglyceride levels were compared between 3 months pre-conversion and 3 months post-conversion using a Friedman test and a post hoc Wilcoxon signed-rank test. A total of 46 patients were included. The median age was 62 years, and 29 were men. IR was continued for 698 (280, 1183) days before the conversion. During the last 3-month IR therapy, serum triglyceride levels remained unchanged from 171 (138, 239) mg/dL to 181 (123, 245) mg/dL ( = 0.78). Following the conversion, no patients had drug-related adverse events, and all patients completed 3-month XR therapy. At three months after the conversion, the serum triglyceride levels decreased significantly from 181 (123, 245) mg/dL to 146 (107, 184) mg/dL ( < 0.001). Pemafibrate XR might be a more promising medication than conventional IR in improving hypertriglyceridemia, probably due to improved medication adherence.
佩马贝特是一种新型的选择性过氧化物酶体增殖物激活受体-α调节剂，在多项临床研究以及II期和III期临床试验中已证明其能降低血清甘油三酯水平，且药物相关不良事件较少。这种药物的局限性之一是需要每日口服两次，这导致用药依从性降低，尤其是在老年患者中，而老年患者恰恰是这种药物的理想适用对象。最近，一种每日一次的缓释（XR）片剂已上市。鉴于用药依从性的提高，佩马贝特的治疗效果可能会增强。2023年至2024年期间，将常规每日两次的速释（IR）佩马贝特转换为佩马贝特XR的高甘油三酯血症患者符合条件。每种片剂分别服用三个月。未尝试改变剂量。使用Friedman检验和事后Wilcoxon符号秩检验比较转换前3个月和转换后3个月的血清甘油三酯水平。共纳入46例患者。中位年龄为62岁，男性29例。转换前IR持续了698（280，1183）天。在最后3个月的IR治疗期间，血清甘油三酯水平从171（138，239）mg/dL保持不变至变为181（123，245）mg/dL（ = 0.78）。转换后，无患者发生药物相关不良事件，所有患者均完成了3个月的XR治疗。转换后三个月，血清甘油三酯水平从181（123，245）mg/dL显著降至146（107，184）mg/dL（ < 0.001）。在改善高甘油三酯血症方面，佩马贝特XR可能比传统的IR更有前景，这可能是由于用药依从性提高所致。
