Adding fibrates improves liver biochemistries in patients with primary biliary cholangitis and suboptimal response to ursodeoxycholic acid.
As there are no consistent data regarding the course and outcome, Dr Albert Parés of Barcelona and colleagues from Spain assessed the effects of the combined treatment with ursodeoxycholic acid and bezafibrate on a long-term basis.
A total of 48 patients with primary biliary cholangitis treated with ursodeoxycholic acid and alkaline phosphatase above 1.5 times upper normal levels were treated with bezafibrate plus ursodeoxycholic acid.
The researchers assessed changes in clinical features, liver biochemistries, and prognosis after therapy as well as pruritus, using a visual analog scale and the 5-D descriptive pruritus scale.
After a median of 38 months, 26 patients had normalized alkaline phosphatase.
|Itching recurrence or worsening was observed after bezafibrate discontinuation|
|American Journal of Gastroenterology|
The doctors found that in these patients, jaundice, pruritus, and liver stiffness was lower, and age was higher than in patients who remained with elevated alkaline phosphatase.
Biochemical improvement was less prominent in patients without alkaline phosphatase normalization.
The team observed that 5 of these patients developed events of disease progression, of which 1 died, 3 were transplanted, and 1 developed hepatocellular carcinoma.
The team reported partial or complete itching relief in all but one case with pruritus.
Itching recurrence or worsening was observed after bezafibrate discontinuation.
Dr Parés's team concludes, "The long-term treatment with ursodeoxycholic acid and bezafibrate results in excellent response, and is associated with a complete or partial itching relief."
"Incomplete alkaline phosphatase normalization was observed in patients with advanced disease who remained at risk for developing severe events."
"The combined treatment is mainly effective in patients with lower fibrosis and severity of cholestasis."