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


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.


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

Full Text:



Erlinger S. Bile flow. In: Arias IM, Boyer JL, Fausto N, Jakoby WB, Schacter D, Shafritz DA, eds. The Liver: Biology and Pathobiology. 3rd edition. New York: Raven Press; 1994:769-788.

Ghonem NS, Assis DN, Boyer JL. On fibrates and cholestasis: A review. Hepatology. 2015;62:635-43.

European Association for the Study of the Liver. EASL Clinical Practice Guidelines: Management of cholestatic liver diseases. J Hepatol. 2009;51:237-67.

Karlsen TH, Vesterhus M, Boberg KM. Review article: Controversies in the management of primary biliary cirrhosis and primary sclerosing cholangitis. Aliment Pharmacol Ther. 2014;39:282-301.

Nandi B, P Hadimani P, Arunachalam R, Ganjoo RK. Spectrum of acute viral hepatitis in Southern India. Med J Armed Forces India. 2009;65:7-9.

Tung BY, Carithers Jr RL. Cholestasis and alcoholic liver disease. Clin Liver Dis. 1999;3:585-601.

Kullak-Ublick GA. Drug-Induced Cholestatic Liver Disease. In: Madame Curie Bioscience Database. Austin (TX): Landes Bioscience; 2000-2013. Available from: Accessed on 20 January 2016.

Rishe E, Azarm A, Bergasa NV. Itch in primary biliary cirrhosis: a patients' perspective. Acta Derm Venereol. 2008;88:34-7.

Montagnese S, Nsemi LM, Cazzagon N, Facchini S, Costa L, Bergasa NV,et al. Sleep-Wake profiles in patients with primary biliary cirrhosis. Liver Int. 2013;33(2):203-9..

Kumar D, Tandon RK. Fatigue in cholestatic liver disease a perplexing symptom Postgrad Med J. 2002;78:404-7.

Younossi Z M, Zheng L, Stepanova M, Venkatesan C, Mishra A. Clinical outcomes and resource utilisation in Medicare patients with chronic liver disease: a historical cohort study. BMJ Open. 2014;4:e004318.

Trauner M, Graziadei IW. Review article: mechanisms of action and therapeutic applications of ursodeoxycholic acid in chronic liver diseases. Aliment Pharmacol Ther. 1999;13:979-96.

Lam BP, Younossi ZM. Treatment regimens for non-alcoholic fatty liver disease. Ann Hepatol. 2009;8:S51-9.

Chen W, Liu J, Gluud C. Bile acids for viral hepatitis. Cochrane Database Syst Rev. 2007;(4):CD003181.

Fischer S, Müller I, Zündt BZ, Jüngst C, Meyer G, Jüngst D et al. Ursodeoxycholic acid decreases viscosity and sedimentable fractions of gallbladder bile in patients with cholesterol gallstones. Eur J Gastroenterol Hepatol. 2004;16:305-11.

Lazaridis KN, Gores GJ, Lindor KD. Ursodeoxycholic acid ‘mechanisms of action and clinical use in hepatobiliary disorders’. J Hepatol. 2001;35:134-46

Balasubramanian J, Swathi V, Gopinath C. Post marketing surveillance: a real - life effectiveness of essential medicines in Indian population. Int J Curr Pharm Res. 2014;6:8-14.

Sclair S, Little E, Levy C. Current Concepts in Primary Biliary Cirrhosis and Primary Sclerosing Cholangitis. Clin Transl Gastroenterol. 2015;6:e109

Kumar DS, Balakrishnan V, Vasudevan DM. Alcohol: Its health and social impact in India. Nat Med J India. 2006;19:94-9.

Duseja A. Nonalcoholic fatty liver disease in India - a lot done, yet more required! Indian J Gastroenterol. 2010;29:217-25.

Sorrentino P, Tarantino G, Perella A, et al. A Clinical–Morphological Study on Cholestatic Presentation of Nonalcoholic Fatty Liver Disease. Dig Dis Sci. 2005;50:1130-5.

Zhu J, Shi Y, Zhou X, Li Z, Huang X, Han Z, et al. Observation on therapeutic efficacy of ursodeoxycholic acid in Chinese patients with primary biliary cirrhosis: a 2-year follow-up study. Front Med. 2013;7:255-63.

Wang H and Yosipovitch G. New insights into the pathophysiology and treatment of chronic itch in patients with End-stage renal disease,Chronic liver disease and Lymphoma. Int J Dermatol. 2010;49:1-11.