Prospective Multicenter Observational Study of Overt Hepatic Encephalopathy

C. S. Landis, Marwan Ghabril, V. Rustgi, A. M. Di Bisceglie, B. Maliakkal, D. C. Rockey, J. M. Vierling, J. Bajaj, R. Rowell, M. Santoro, A. Enriquez, M. Jurek, M. Mokhtarani, D. F. Coakley, B. F. Scharschmidt

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Background: Overt hepatic encephalopathy (OHE) is a frequent complication of decompensated cirrhosis. Aims: A multicenter prospective observational study was performed to assess the most commonly recorded presenting manifestations of OHE and its associated health-care burden. Methods: Qualifying patients must have experienced ≥1 OHE episode within 30 days of enrollment (qualifying OHE) and were followed for recurrence (on-study OHE). Results: 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. Conclusions: 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.

Original languageEnglish (US)
Pages (from-to)1-7
Number of pages7
JournalDigestive Diseases and Sciences
DOIs
StateAccepted/In press - Jan 19 2016

Fingerprint

Hepatic Encephalopathy
Multicenter Studies
Observational Studies
Confusion
rifaximin
Lethargy
Dyskinesias
Recurrence
Hospitalization
Prospective Studies
Delivery of Health Care
Fibrosis

Keywords

  • Altered mental status
  • Chronic liver disease
  • Cirrhosis
  • Clinical trial
  • Health-care burden
  • Liver failure
  • Pharmacoeconomics

ASJC Scopus subject areas

  • Gastroenterology
  • Physiology

Cite this

Landis, C. S., Ghabril, M., Rustgi, V., Di Bisceglie, A. M., Maliakkal, B., Rockey, D. C., ... Scharschmidt, B. F. (Accepted/In press). Prospective Multicenter Observational Study of Overt Hepatic Encephalopathy. Digestive Diseases and Sciences, 1-7. https://doi.org/10.1007/s10620-016-4031-7

Prospective Multicenter Observational Study of Overt Hepatic Encephalopathy. / Landis, C. S.; Ghabril, Marwan; Rustgi, V.; Di Bisceglie, A. M.; Maliakkal, B.; Rockey, D. C.; Vierling, J. M.; Bajaj, J.; Rowell, R.; Santoro, M.; Enriquez, A.; Jurek, M.; Mokhtarani, M.; Coakley, D. F.; Scharschmidt, B. F.

In: Digestive Diseases and Sciences, 19.01.2016, p. 1-7.

Research output: Contribution to journalArticle

Landis, CS, Ghabril, M, Rustgi, V, Di Bisceglie, AM, Maliakkal, B, Rockey, DC, Vierling, JM, Bajaj, J, Rowell, R, Santoro, M, Enriquez, A, Jurek, M, Mokhtarani, M, Coakley, DF & Scharschmidt, BF 2016, 'Prospective Multicenter Observational Study of Overt Hepatic Encephalopathy', Digestive Diseases and Sciences, pp. 1-7. https://doi.org/10.1007/s10620-016-4031-7
Landis, C. S. ; Ghabril, Marwan ; Rustgi, V. ; Di Bisceglie, A. M. ; Maliakkal, B. ; Rockey, D. C. ; Vierling, J. M. ; Bajaj, J. ; Rowell, R. ; Santoro, M. ; Enriquez, A. ; Jurek, M. ; Mokhtarani, M. ; Coakley, D. F. ; Scharschmidt, B. F. / Prospective Multicenter Observational Study of Overt Hepatic Encephalopathy. In: Digestive Diseases and Sciences. 2016 ; pp. 1-7.
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abstract = "Background: Overt hepatic encephalopathy (OHE) is a frequent complication of decompensated cirrhosis. Aims: A multicenter prospective observational study was performed to assess the most commonly recorded presenting manifestations of OHE and its associated health-care burden. Methods: Qualifying patients must have experienced ≥1 OHE episode within 30 days of enrollment (qualifying OHE) and were followed for recurrence (on-study OHE). Results: 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. Conclusions: 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.",
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author = "Landis, {C. S.} and Marwan Ghabril and V. Rustgi and {Di Bisceglie}, {A. M.} and B. Maliakkal and Rockey, {D. C.} and Vierling, {J. M.} and J. Bajaj and R. Rowell and M. Santoro and A. Enriquez and M. Jurek and M. Mokhtarani and Coakley, {D. F.} and Scharschmidt, {B. F.}",
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AU - Landis, C. S.

AU - Ghabril, Marwan

AU - Rustgi, V.

AU - Di Bisceglie, A. M.

AU - Maliakkal, B.

AU - Rockey, D. C.

AU - Vierling, J. M.

AU - Bajaj, J.

AU - Rowell, R.

AU - Santoro, M.

AU - Enriquez, A.

AU - Jurek, M.

AU - Mokhtarani, M.

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AU - Scharschmidt, B. F.

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N2 - Background: Overt hepatic encephalopathy (OHE) is a frequent complication of decompensated cirrhosis. Aims: A multicenter prospective observational study was performed to assess the most commonly recorded presenting manifestations of OHE and its associated health-care burden. Methods: Qualifying patients must have experienced ≥1 OHE episode within 30 days of enrollment (qualifying OHE) and were followed for recurrence (on-study OHE). Results: 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. Conclusions: 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.

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KW - Health-care burden

KW - Liver failure

KW - Pharmacoeconomics

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