Abstract

Hepatic encephalopathy (HE) describes a spectrum of potentially reversible neuropsychiatric changes observed in patients with hepatic dysfunction and/or portosystemic shunt. The aim of this study is to compare data from clinical trials and observational studies with Italian real-world (RW) data as for clinical outcomes; other aim is to evaluate economic burden of hepatic encephalopathy related to hospitalization for overt HE. The work is based on data from the Health Information Systems (SIS) of Marche Region, Italy (about 1.5 million patients) available for the period 2008-2014. 450 subjects were identified (62% men, mean age 68 years) with a first episode of overt HE (OHE) in the three-year period 2010-2012. The mortality in the index hospitalization was equal to 32.2%; the 2-year mortality rate for a specific cause was 24.3% while that for all cases was 33.1%. The proportion of patients discharged alive from the hospitalization index that in the following two years incurs in rehospitalization, correlated with OHE is on average 66.6%. These figures largely exceed those identified in clinical trials or observational studies. Assuming that the incidence of OHE cases observed in the Marche region is representative of the national one we could estimate a charge to the NHS equal to about € 200 million for hospital assistance in the first year from the OHE event.

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