(HealthDay)—Nearly one-third of patients with primary biliary cholangitis who had had an inadequate response to ursodeoxycholic acid alone achieved a complete biochemical response with the addition of bezafibrate to treatment, according to a study published online June 7 in the New England Journal of Medicine.
Christophe Corpechot, M.D., from Saint-Antoine University Hospital in Paris, and colleagues randomly assigned 100 patients with primary biliary cholangitis who had had an inadequate response to ursodeoxycholic acid to receive either bezafibrate (400 mg daily) or placebo, plus continued treatment with ursodeoxycholic acid.
The researchers found that 31 percent of the patients assigned to bezafibrate had a complete biochemical response (normal levels of total bilirubin, alkaline phosphatase, aminotransferases, and albumin as well as a normal prothrombin index) versus none assigned to placebo. Changes in pruritus, fatigue, and noninvasive measures of liver fibrosis, including liver stiffness and Enhanced Liver Fibrosis score, paralleled the biochemical responses. Two patients in each group had complications from end-stage liver disease, while myalgia occurred more often in the bezafibrate group than the placebo group (20 versus 10 percent).
“Among patients with primary biliary cholangitis who had had an inadequate response to ursodeoxycholic acid alone, treatment with bezafibrate in addition to ursodeoxycholic acid resulted in a rate of complete biochemical response that was significantly higher than the rate with placebo and ursodeoxycholic acid therapy,” the authors write.
Several authors disclosed financial ties to the pharmaceutical industry; the study was funded in part by Arrow Génériques.
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