Korean J Gastroenterol.  2021 Oct;78(4):227-234. 10.4166/kjg.2021.092.

Effects of Switching from Fenofibrate to Pemafibrate for Asymptomatic Primary Biliary Cholangitis

• Dohmen K
• Onohara Sy
• Harada S

• KMID: 2521497
• DOI: http://doi.org/10.4166/kjg.2021.092

Abstract

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.
Methods
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.
Results
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).
Conclusions
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.

Keyword

Primary biliary cholangitis; Pemafibrate; Bezafibrate; Fenofibrate; Glomerular filtration rate; Creatinine

Figure

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  Fig. 1 Changes in the serum creatinine levels in patients with aPBC treated with fenofibrate plus UDCA. aPBC, asymptomatic primary biliary cholangitis; UDCA, ursodeoxycholic acid.

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  Fig. 2 Changes in the eGFR in patients with aPBC treated with fenofibrate plus UDCA. eGFR, estimated glomerular filtration rate; aPBC, asymptomatic primary biliary cholangitis; UDCA, ursodeoxycholic acid.

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  Fig. 3 Changes in the serum creatinine levels in patients with aPBC treated with pemafibrate plus UDCA after switching from fenofibrate plus UDCA. aPBC, asymptomatic primary biliary cholangitis; UDCA, ursodeoxycholic acid.

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  Fig. 4 Changes in the eGFR in patients with aPBC treated with pemafibrate plus UDCA after switching from fenofibrate plus UDCA. eGFR, estimated glomerular filtration rate; aPBC, asymptomatic primary biliary cholangitis; UDCA, ursodeoxycholic acid.

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