Digestive and Liver Disease - Volume 48 - Supplement 2

Abstracts of the 22

National Congress of Digestive Diseases / Digestive and Liver Disease 48S2 (2016) e67–e231

e81

Conclusions:

In this study NUNA Nutritional Navigator as an adjunct

to lifestyle advices, was associated with improved Sofi-MDS and

reduced body weight.

OC.03.4

EFFICACY AND SAFETY OF OBETICHOLIC ACID IN PATIENTS

WITH PRIMARY BILIARY CIRRHOSIS: AN ANALYSIS OF THE

ITALIAN PATIENTS FROM A PHASE 3, RANDOMIZED, PLACEBO-

CONTROLLED STUDY

Andreone P.

, Mazzella G.

, Invernizzi P.

, Floreani A.

, Picaro L.A.*

Adorini L.

University of Bologna, Bologna, Italy,

Humanitas Clinical and

Research Center, Rozzano (MI), Italy,

University of Padua, Padua, Italy,

Intercept Pharmaceuticals LTD Europe, London, United Kingdom,

Intercept Pharmaceuticals Inc, S. Diego, California, United States

Background and aim:

Obeticholic acid (OCA) is a potent, selective

farnesoid X receptor (FXR) agonist currently under investigation for

the treatment of primary biliary cirrhosis (PBC). This study evaluated

the efficacy and safety of OCA for the treatment of PBC.

Material and methods:

This is a subgroup analysis of Italian

patients who participated in an international Phase 3, 12 month,

double-blind, placebo-controlled trial. Eligible patients with PBC

who had an alkaline phosphatase (ALP) > 1.67X ULN and/or bilirubin

> ULN but <2X ULN were randomized to receive OCA 5 mg with the

ability to up-titrate to 10 mg after 6 months (Titration OCA), OCA 10

mg or placebo. Patients were permitted to remain on stable doses

ursodeoxycholic acid (UDCA). The primary composite endpoint

was the proportion of patients with an ALP <1.67X ULN and a >15%

reduction in ALP and a total bilirubin <ULN.

Results:

Thirty-two out of 216 intent-to-treat patients were at

Italian sites. In the Italian patient group the mean age was 52.3

years, 84% were female, and 94% were on a UDCA. The majority of

patients (91%) completed the double-blind portion of the study. The

percentage of patients at the Italian sites achieving the primary

composite endpoint at 52 weeks was consistent with the total study

population. The baseline values for the placebo, Titration OCA and

OCA 10 mg for: ALP (U/L): 314.6, 302.2, 312.6, respectively; total

bilirubin (µmol/L): 14.4, 12.0, 13.4, respectively; AST (U/L): 56.7,

49.8, 46.5, respectively; ALT (U/L): 60.5, 58.0, 45.4, respectively; GGT

(U/L): 325.4, 287.9, 223.6, respectively. The 12 month values for the

placebo, Titration OCA and OCA 10 mg for: ALP (U/L): 365.9, 188.2,

188.3, respectively; total bilirubin (µmol/L): 16.8, 11.4, 10.8,

respectively; AST (U/L): 62.2, 35.0, 35.7, respectively; ALT (U/L): 61.1,

29.7, 28.8, respectively; GGT (U/L): 298.1, 84.1, and 57.7, respectively.

The laboratory results for the Italian patients were consistent with

the overall population. Mild to moderate pruritus was the most

common treatment emergent adverse event (TEAE) and occurred in

45%, 64% and 50% of patients in the placebo, Titration OCA, 10 mg

OCA groups respectively. There were no differences between the

groups for any other TEAE.

Conclusions:

In this study, OCA (± UDCA) given to patients with PBC

at the Italian sites produced clinically meaningful improvements

in liver biochemistry. The results were consistent with the overall

study population.

OC.03.5

COGNITIVE IMPAIRMENT PREDICTS THE OCCURRENCE

OF HEPATIC ENCEPHALOPATHY AFTER TRANSJUGULAR

INTRAHEPATIC PORTOSYSTEMIC SHUNT

Nardelli S.*, Gioia S., Pasquale C., Pentassuglio I., Merli M., Riggio O.

Policlinico Umberto I, Rome, Italy

Background and aim:

Hepatic encephalopathy is a major problem

in patients treated with TIPS. The aim of the study was to establish

whether pre-TIPS covert HE is an independent risk factors for the

development of HE after TIPS.

Material and methods:

82 consecutive cirrhotic patients submitted

to TIPS were included (Gendere 57 M; Age 57.9 ± 10.1 yrs; MELD

11.2 ± 3.6; CPT class A 17, B 53, C 12; TIPS indication: 37 bleeding,

45 refractory ascites). All patients underwent the PHES to identify

those affected by covert HE before TIPS. The incidence of the first

episode of HE taking into account the competing risk nature of the

data (death or liver transplantation) was estimated.

Results:

Thirty-five (43%) patients developed overt HE. The

difference of post TIPS HE was highly significant (p=0.0003) between

the patients with or without covert HE before TIPS. Seventy-seven %

of the patients with post TIPS HE were classified as affected by

covert HE before TIPS. Age: (sHR 1.05, CI 1.02-1.08, p=0.002);

C-PSCORE: (sHR 1.29, CI 1.06-1.56, p=0.01) and covert HE: (sHR 3.16

CI: 1.43-6.99 p=0.004) were associated to post TIPS HE. Taking into

consideration only the results of PHES evaluation, the negative

predicting value was 0.80 for all patients and 0.88 for the patients

submitted to TIPS because of refractory ascites. Thus, a patient with

refractory ascites, without covert HE before TIPS, has almost 90%

probability to be free of HE after TIPS.

Conclusions:

Psychometric evaluation before TIPS is able to identify

the large majority of the patients who will develop HE after TIPS

and can be used to select the patients in order to have the lowest

incidence of this important complication.