Gastrointestinal and Hepato-Biliary-Pancreatic Center, Chihaya Hospital, Fukuoka, Japan.
Korean J Gastroenterol. 2021 Oct 25;78(4):227-234. doi: 10.4166/kjg.2021.092.
BACKGROUND/AIMS: The addition of a fibrate to ursodeoxycholic acid (UDCA) is the standard treatment for asymptomatic primary biliary cholangitis (aPBC) with an incomplete response to UDCA. Among the fibrates, bezafibrate and fenofibrate increase the serum creatinine level and reduce the estimated glomerular filtration rate (eGFR). Pemafibrate is an selective peroxisome proliferator-activated receptor alpha modulator (SPPARM-α) mainly metabolized by the liver that was recently approved to treat dyslipidemia. This study confirmed the changes in the biochemical markers after switching from fenofibrate to pemafibrate in aPBC patients.
This study examined the effects of switching treatment from fenofibrate to pemafibrate in 16 aPBC patients. The biological parameters of these patients were examined at the initiation of fenofibrate and after switching to pemafibrate, then at 24 and 48 weeks later, respectively.
Among patients with aPBC treated with UDCA and fenofibrate, the ALP, GGT, and serum IgM levels decreased significantly (p<0.0001) over 48 weeks. On the other hand, serum creatinine levels increased significantly, and eGFR decreased significantly (p<0.0001). After switching to pemafibrate plus UDCA, patients with aPBC exhibited significantly lower serum creatinine levels (p=0.007) and significantly higher eGFR levels (p=0.014).
Pemafibrate has therapeutic efficacy for aPBC patients with an inadequate response to UDCA. Pemafibrate might be another option for aPBC patients given its beneficial effects on renal function, but larger, multicenter studies with a longer follow-up are needed.
背景/目的：对于熊去氧胆酸（UDCA）治疗应答不完全的无症状原发性胆汁性胆管炎（aPBC），添加贝特类药物是标准治疗方法。在贝特类药物中，苯扎贝特和非诺贝特会升高血清肌酐水平并降低估算肾小球滤过率（eGFR）。培马贝特是一种选择性过氧化物酶体增殖物激活受体 α 调节剂（SPPARM-α），主要在肝脏中代谢，最近被批准用于治疗血脂异常。本研究证实了在 aPBC 患者中从非诺贝特转换为培马贝特后生化标志物的变化。
本研究检查了 16 例 aPBC 患者从非诺贝特转换为培马贝特治疗的效果。这些患者的生物学参数在开始使用非诺贝特时、转换为培马贝特后 24 周和 48 周时分别进行了检查。
在接受 UDCA 和非诺贝特治疗的 aPBC 患者中，ALP、GGT 和血清 IgM 水平在 48 周内显著下降（p<0.0001）。另一方面，血清肌酐水平显著升高，eGFR 显著下降（p<0.0001）。在转换为培马贝特加 UDCA 后，aPBC 患者的血清肌酐水平显著降低（p=0.007），eGFR 水平显著升高（p=0.014）。
培马贝特对 UDCA 应答不足的 aPBC 患者具有治疗效果。培马贝特可能是另一种选择，因为它对肾功能有益，但需要更大规模、多中心、更长随访时间的研究。
