Efficacy and safety of fenofibrate combined with ursodeoxycholic acid in the treatment of primary biliary cholangitis with poor biochemical response
10.3760/cma.j.cn114015-20220801-00697
- VernacularTitle:非诺贝特联合熊去氧胆酸治疗生化应答不佳原发性胆汁性胆管炎的疗效与安全性
- Author:
Lijuan FENG
1
;
Weijia DUAN
1
;
Shuxiang LI
1
;
Tingting LYU
1
;
Sha CHEN
1
;
Jidong JIA
1
;
Xinyan ZHAO
1
Author Information
1. 首都医科大学附属北京友谊医院肝病中心，国家消化系统疾病临床医学中心，北京 100050
- Publication Type:Journal Article
- Keywords:
Cholangitis;
Chemical and drug induced liver injure;
Renal insufficiency;
Ursodeoxycholic acid;
Fenofibrate
- From:
Adverse Drug Reactions Journal
2023;25(2):83-88
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To explore the efficacy and safety of fenofibrate combined with ursodeoxycholic acid (UDCA) in the treatment of primary biliary cholangitis (PBC) with poor biochemical response.Methods:The medical records of early PBC patients who were diagnosed with poor biochemical response to UDCA and treated with fenofibrate in Outpatient Department of the Liver Research Center of Beijing Friendship Hospital, Capital Medical University from January 2010 to January 2018 were collected and analyzed retrospectively, so as to evaluate the efficacy and safety of combination treatment. The combination treatment regimen consisted of fenofibrate and UDCA. The efficacy indicators were the efficacy rate and biochemical response rate. When the serum alkaline phosphatase (ALP) decreased to below the baseline value before treatment after 12 months of combination therapy, it was defined as effectiveness, and when it decreased to <1.5 times of upper limit of normal (ULN), the biochemical response was achieved. The safety indicator was the incidence of adverse reactions (liver injury, kidney injury, etc.) related to fenofibrate.Results:A total of 42 patients were enrolled in the analysis, including 12 males and 30 females. The age was (53±10) years when fenofibrate was added and the duration of combination therapy was from 5 days to 34 months. The efficacy analysis of 34 patients with combined treatment showed that the average level of ALP decreased from the baseline value after 12 months of treatment, of which 10 patients (29.4%) fell to the reference value range, and the effective rate was 100%. The ALP was 235 (210, 326) U/L before treatment and decreased to 134 (104, 190) U/L after 12 months of treatment, with a statistically significant difference ( P=0.001). Of the 34 patients, 25 (73.5%) achieved biochemical response. The ALP before treatment was 221 (198, 256) U/L and decreased to 125 (99, 143) U/L after 12 months of treatment, with a statistically significant difference ( P=0.010). Of the 42 patients, 16 (38.1%) developed adverse reactions related to fenofibrate, including liver injury in 8 patients (19.0%, one case was complicated with hearthurn), kidney injury in 4 patients (9.5%), myalgia, facial edema, heartburn, headache, and skin itch with rash in 1 patient each (each 2.3%). Of the 8 patients with liver injury, 4 were mild, 1 was moderate, and 3 were severe; the mild cases were not intervened, and the alanine aminotransferase (ALT) returned to the baseline level after 2 months; in moderate and severe cases, ALT and total bilirubin returned to the baseline level after stopping fenofibrate and receiving liver protection treatment. Of the 4 patients with renal injury, the serum creatinine (Scr) in 2 patients returned to the baseline level after withdrawal of fenofibrate, in the other 2 patients it recovered to the reference value range spontaneously without drug withdrawal. Conclusions:Fenofibrate combination with UDCA is effective in the treatment of early PBC patients with poor biochemical response, the rate of biochemical response is 73.5%. The common adverse reactions of fenofibrate are liver injury and kidney injury. During the medication, the patients′ liver and kidney function should be closely monitored.
