DOI: http://dx.doi.org/10.18203/2319-2003.ijbcp20164135

A prospective, multicentre, observational study of patients with chronic cholestatic liver diseases receiving Udiliv® in India: Splendid study

Parimal Lawate, Ramesh Rooprai, Gourdas Choudhury, Sangitanjan Dutta

Abstract


Background: Data on clinical spectrum and etiology of chronic cholestatic liver disease (CCLD) in Indian patients is limited. This prospective, observational real-world study aimed to profile patients with CCLD being recommended Udiliv®, determine reasons for recommendation along with its safety and effectiveness.

Methods: CCLD patients (18-65 years) scheduled to receive Udiliv® as part of routine clinical practice were enrolled. Healthcare utilizations, clinical manifestations (jaundice, pruritus, fatigue) and liver biochemistry were assessed over 12 weeks. Reasons for recommending Udiliv® were recorded at the initiation of therapy.

Results: The intent-to-treat analysis population included 248 patients. The mean (±SD) age was 44.1(11.8) years and 78.23% were males. Majority (89.1%) were classified as intrahepatic cholestasis (IHC). Most common etiologies of IHC were alcoholic liver disease (ALD) (39.92%) and viral hepatitis (24.60%) followed by non-alcoholic fatty liver disease (NAFLD) (22.18%), which is less well known. Udiliv®, 300 mg twice daily was preferred dose due to known efficacy (73.39%), as standard of care (62.5%) and good tolerability (45.56%). There was reduction in healthcare visits, inpatient hospitalization and days off work, within 4 weeks of treatment initiation (P<0.0001). There was improvement in clinical presentation (P<0.0001) and reduction in biochemical markers over 12 weeks. The treatment was well-tolerated.

Conclusions: NAFLD, a less perceived etiology for CCLD, was found to be a significant contributor to CCLD. Physicians recommend Udiliv® due to its known efficacy and tolerability. Udiliv® reduced CCLD disease burden and was found to be an effective and well-tolerated treatment option.


Keywords


Alcoholic liver disease, Cholestasis, Non-alcoholic fatty liver disease, Ursodeoxycholic acid

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