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A Placebo-controlled Trial of Bezafibrate in Primary Biliary Cholangitis
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Edité par CCSD ; Massachusetts Medical Society -
International audience. BACKGROUNDPatients with primary biliary cholangitis (PBC) who inadequately respond to ursodeoxycholic acid (UDCA) therapy are at high risk of disease progression. Fibrates, which are agonists of peroxisome proliferator-activated receptors, in combination with UDCA, have shown potential benefit in this condition.METHODSIn this 24-month, double-blind, placebo-controlled, phase 3 trial, we randomly assigned 100 patients who had an inadequate response to UDCA according to the Paris-2 criteria to receive bezafibrate, at a daily dose of 400 mg (n=50), or placebo (n=50), in addition to continued treatment with UDCA. The primary outcome was a complete biochemical response defined as normal levels at 24 months of all of the following: total bilirubin, alkaline phosphatase (ALP), aminotransferases, albumin, and prothrombin index.RESULTSThe primary outcome occurred in 30% of patients with bezafibrate and 1% with placebo (difference [95%CI] = 29% [16% ; 43%]; P < 0.001). Normalization of ALP occurred in 67% of patients with bezafibrate and 2% with placebo. Changes in pruritus, fatigue, and non-invasive markers of liver fibrosis, including liver stiffness measurement and Enhanced Liver Fibrosis score, were consistent with the primary outcome. Two patients in each group experienced end-stage liver complications. Creatinine level increased 5% in the bezafibrate group and decreased 3% in the placebo group. Myalgia was experienced by 20% in bezafibrate and 10% in placebo group.CONCLUSIONSBezafibrate administered with UDCA in patients with PBC who had inadequate response to UDCA alone resulted in a significantly higher rate of complete biochemical response than placebo with UDCA. (Funded by the Assistance Publique–Hôpitaux de Paris with support from Arrow Génériques; BEZURSO ClinicalTrials.gov number, NCT01654731).
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