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5PSQ-001 Efficacy of obeticholic acid in patients with primary biliary cirrhosis and inadequate response to ursodeoxycholic acid
  1. R Mesa Expósito,
  2. MDP Díaz Ruiz,
  3. M Suárez González,
  4. E Tevar Afonso,
  5. MA Navarro Dávila,
  6. A González Rodríguez,
  7. F Pérez Hernández,
  8. CL Diaz Diaz,
  9. I González García,
  10. FJ Merino Alonso
  1. Hospital Nuestra Señora de la Candelaria, Pharmacy, Santa Cruz de Tenerife, Spain


Background Obeticholic acid (OCA) is a synthetically modified bile acid that is used to treat a rare disease, the primary biliary cholangitis (PBC). OCA has been recently used in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well enough to UDCA, or alone for adults who cannot tolerate UDCA.

Purpose To evaluate the clinical results obtained from patients with PBC who were treated with OCA in our hospital.

Material and methods In this study, all patients diagnosed with PBC, who were treated with OCA in our hospital were located. The primary endpoint was the percentage change in alkaline phosphatase (ALP) from baseline. Secondary endpoints included dose of OCA, change from baseline in markers of cholestasis and hepatocellular injury, analysis of possible interactions with concomitant treatments, side effects and their management.

The Electronic Clinical History (SELENE) and the Pharmacy Service Managing Software (FARMATOOLS) were used for the location and collection of clinical data.

Results A total of four patients were evaluated. They were all women with a mean age of 46 years (39–57), an average of 10 years (6–14) since the diagnosis, stage 3 fibrosis and a dose of 5 mg/day of OCA in combination with UDCA.

The mean baseline values of ALP were 273 IU/L (182–401) and all patients had normal values of total bilirubin. Half of the patients achieved a 50% reduction in baseline levels of ALP after 60 days of treatment. The baseline levels of alanine aminotransferase decreased by 32% (23–43) in three patients after 7 weeks. The baseline triglyceride levels increased by an average of 38% (4–171) and baseline HDL levels decreased 30% (26–32).

The only interaction detected was with the ion exchange resins, whose intake was spaced as much as possible from the OCA administration. The main side effects were pruritus, facial rash and diarrhoea. All the patients presented intense pruritus that could be controlled with the use of antihistamines.

Conclusion OCA has shown an excellent early response until now, improving levels of ALP with an acceptable safety profile. The most frequent adverse reaction is pruritus, which seems to be tolerated acceptably with pharmacological agents.

References and/or acknowledgements I would like to express my gratitude to my co-workers.

No conflict of interest.

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