Background and importance Primary biliary cholangitis (PBC) is a disease with few therapeutic options. Currently the main drug used is ursodeoxycholic acid (UDCA), although approximately 35% of patients will have an inadequate biochemical response after 1 year of treatment. In these patients, the association of UDCA and obeticholic acid (OCA) is indicated, while in cases of intolerance to UDCA, OCA is used as monotherapy.
Aim and objectives To evaluate the efficacy of OCA in patients with PBC based on different biochemical response parameters.
Material and methods An observational, descriptive and retrospective study was carried out in three third-level hospitals in the Canary Islands. Based on the FarmaTools e-prescribing program, a total of 30 patients with a diagnosis of PBC undergoing OCA treatment for at least 3 months were selected. Clinical data were collected: sex, age, date of initiation with OCA. To evaluate the efficacy, the analytical data were extracted from the electronic medical record (Drago AE and SAP): alkaline phosphatase (AF), total bilirubin (BT), gamma glutamyltransferase (GGT), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) at the beginning and every 12 weeks of treatment. Statistical analysis was performed using Microsoft Excel.
Results Thirty patients (90% women) with a mean age of 55 years were included. All previously treated with UDCA for at least 1 year without good response and, subsequently, it remained concomitant with OCA. After 3 months of treatment, the following results were obtained: AF was reduced in 77% of the patients by 31%±22%; in 50% the BT was reduced by 23%±15%; in 83% the GGT decreased by 43%±27%; in 63% the AST decreased by 24%±17% and in 70% the ALT values were reduced by 27%±18%. Of the 30 patients, 19 reached 1 year of treatment of which: in 79% AF and AST were reduced by 46%±265 and 28%±20%, respectively; 32% decreased BB by 30%±24%; GGT decreased in 84% of patients by 68%±37% and ALT decreased in 100% by 38%±23%.
Conclusion and relevance According to the literature, OCA has improved the analytical parameters of the analysed sample, demonstrating its effectiveness in the treatment of PBC in patients who have not previously responded to UDCA therapy.
Conflict of interest No conflict of interest
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