title: Prospective Multicenter Observational Study of Overt Hepatic Encephalopathy.
abstract: Overt hepatic encephalopathy (OHE) is a frequent complication of decompensated cirrhosis.
  
  
  
  A multicenter prospective observational study was performed to assess the most commonly recorded presenting manifestations of OHE and its associated health-care burden.
  
  
  
  Qualifying patients must have experienced ≥1 OHE episode within 30 days of enrollment (qualifying OHE) and were followed for recurrence (on-study OHE).
  
  
  
  Two hundred and sixty-five patients were enrolled at 30 sites and followed for up to 9 months (mean 72 days). Seventy-two patients experienced 122 on-study episodes; with 72, 23, and 13 having ≥1, ≥2, or ≥3 on-study episodes with median days to occurrence of the 1st, 2nd, and 3rd episode of 34, 19, and 11, respectively. The most frequently recorded OHE manifestations included confusion (78 %), change in mental status (57 %), disorientation (48 %), lethargy (46 %), and asterixis (45 %). West Haven grade was used inconsistently and recorded for only 28 % of episodes. Most qualifying and on-study episodes occurred on rifaximin (60 and 82 %, respectively) and were associated with hospitalization (68 and 85 %, respectively). Twenty-three patients experienced ≥2 on-study episodes within 2 months of enrollment on average (median 45 days) and accounted for 60 % of on-study episodes.
  
  
  
  In this prospective study, OHE's most commonly recorded presenting manifestations included confusion, altered mental status, disorientation, lethargy, and asterixis. As reflected by frequent recurrence and hospitalizations, OHE, particularly the approximately 10 % of "high-resource-utilizing" patients with frequent recurrence, continues to pose a major unmet medical need and health-care burden despite the use of rifaximin.
authors.affiliation: University of Washington, Seattle, WA, USA.
authors.forename: C S
authors.initials: CS
authors.lastname: Landis
authors.affiliation: Indiana University, Indianapolis, IN, USA.
authors.forename: M
authors.initials: M
authors.lastname: Ghabril
authors.affiliation: University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: V
authors.initials: V
authors.lastname: Rustgi
authors.affiliation: St Louis University, St Louis, MO, USA.
authors.forename: A M
authors.initials: AM
authors.lastname: Di Bisceglie
authors.affiliation: University of Rochester, Rochester, NY, USA.
authors.forename: B
authors.initials: B
authors.lastname: Maliakkal
authors.affiliation: Medical University of South Carolina, Charleston, SC, USA.
authors.forename: D C
authors.initials: DC
authors.lastname: Rockey
authors.affiliation: Baylor College of Medicine, Houston, TX, USA.
authors.forename: J M
authors.initials: JM
authors.lastname: Vierling
authors.affiliation: Virginia Commonwealth University and McGuire VA Hospital, Richmond, VA, USA.
authors.forename: J
authors.initials: J
authors.lastname: Bajaj
authors.affiliation: Horizon Therapeutics, Inc., Deerfield, IL, USA.
authors.forename: R
authors.initials: R
authors.lastname: Rowell
authors.affiliation: Horizon Therapeutics, Inc., Deerfield, IL, USA.
authors.forename: M
authors.initials: M
authors.lastname: Santoro
authors.affiliation: Horizon Therapeutics, Inc., Deerfield, IL, USA.
authors.forename: A
authors.initials: A
authors.lastname: Enriquez
authors.affiliation: Horizon Therapeutics, Inc., Deerfield, IL, USA.
authors.forename: M
authors.initials: M
authors.lastname: Jurek
authors.affiliation: Horizon Therapeutics, Inc., Deerfield, IL, USA.
authors.forename: M
authors.initials: M
authors.lastname: Mokhtarani
authors.affiliation: Horizon Therapeutics, Inc., Deerfield, IL, USA.
authors.forename: D F
authors.initials: DF
authors.lastname: Coakley
authors.affiliation: Horizon Therapeutics, Inc., Deerfield, IL, USA. bruce.scharschmidt@gmail.com.|, 45 St Francis Blvd., San Francisco, CA, 94127, USA. bruce.scharschmidt@gmail.com.
authors.forename: B F
authors.initials: BF
authors.lastname: Scharschmidt
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D006501:Hepatic Encephalopathy / Q000473:pathology*; D006801:Humans; D008103:Liver Cirrhosis / Q000150:complications*; D008875:Middle Aged; D012294:Rifamycins / Q000008:administration & dosage / Q000494:pharmacology; D000078262:Rifaximin; D055815:Young Adult
chemical_list: D012294:Rifamycins; D000078262:Rifaximin
keywords: Altered mental status; Chronic liver disease; Cirrhosis; Clinical trial; Health-care burden; Liver failure; Pharmacoeconomics