Hepatic Encephalopathy News and Research

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Presence and type of cirrhosis complications are strong predictors of mortality: Study

A recent study by Danish researchers discovered patients with alcoholic cirrhosis had a high prevalence of complications at the time of the disease diagnosis.

29 Apr 2010

Salix Pharmaceuticals announces novel patient and health care provider support program for HE

Salix Pharmaceuticals, Ltd. today announced plans for the Hepatic Encephalopathy Living Program (H.E.L.P.). H.E.L.P. is a first-of-its-kind patient and health care provider support program for the management of hepatic encephalopathy (HE) and will launch on May 24, 2010. The program will provide patients with HE educational materials, co-pay assistance, treatment adherence support and a 24-hour toll-free hotline.

27 Apr 2010

Ocera Therapeutics presents data on prevalence of neurocognitive impairment in cirrhotic patients

Ocera Therapeutics, Inc. presented an analysis of the prevalence of neurocognitive impairment in ambulatory cirrhotic patients. The data came from the screening period of the ASTUTE Study, an ongoing Phase 2b study evaluating the safety and efficacy of AST-120 (spherical carbon adsorbent) in the treatment of mild hepatic encephalopathy (MHE). The poster was presented yesterday at the annual meeting of the European Association for the Study of Liver (EASL) in Vienna, Austria. Efficacy and safety data from the ASTUTE study are expected in the summer of 2010.

17 Apr 2010

Cumberland Pharmaceuticals submits Acetadote sNDA for non-acetaminophen acute liver failure

Cumberland Pharmaceuticals Inc. has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure. Acetadote was launched by Cumberland in 2004 as the first U.S.-approved injectable drug to treat acetaminophen overdose.

30 Mar 2010

Hepatic encephalopathy drug XIFAXAN 550 mg tablets receives FDA marketing approval

Salix Pharmaceuticals, Ltd. today announced the U.S. Food and Drug Administration has granted marketing approval for XIFAXAN 550 mg tablets for reduction in risk of overt hepatic encephalopathy recurrence in patients 18 years of age or older. HE is a serious disorder caused by chronic liver failure, resulting in cognitive, psychiatric and motor impairments. This approval was supported by findings from the largest randomized trial of maintenance therapy in HE conducted to date, which assessed the efficacy and safety of XIFAXAN 550 mg tablets and demonstrated a statistically significant and clinically meaningful reduction in the risk of overt HE recurrence.

25 Mar 2010

Xifaxan drug receives FDA approval

The U.S. Food and Drug Administration today approved the use of Xifaxan for reduction in the risk of the recurrence of overt hepatic encephalopathy (HE) in patients with advanced liver disease.

25 Mar 2010

Enrollment complete in Ocera Therapeutics' ASTUTE Phase 2B trial for mild hepatic encephalopathy

Ocera Therapeutics, Inc. announced today that the ASTUTE Study (AST-120 Used to Treat Hepatic Encephalopathy) has completed enrollment for its Phase 2B study ahead of schedule, with data expected mid 2010.

24 Feb 2010

FDA Gastrointestinal Drugs Advisory Committee supports approval of XIFAXAN 550 mg for management of HE

Salix Pharmaceuticals, Ltd. today reported that the Gastrointestinal Drugs Advisory Committee of the FDA has recommended by a vote of 14 to 4 in favor of the approval of XIFAXAN® (rifaximin) Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy (HE).

23 Feb 2010

NASDAQ halts trading of Salix Pharmaceuticals stock, FDA Committee to discuss XIFAXAN NDA

Salix Pharmaceuticals, Ltd. today announced that NASDAQ has halted trading of the Company’s common stock this morning. The Gastrointestinal Drugs Advisory Committee of the FDA is meeting today to discuss the efficacy and safety of the New Drug Application (NDA) for XIFAXAN® (rifaximin) Tablets, 550 mg for the maintenance of remission of hepatic encephalopathy.

23 Feb 2010

Hyperion Therapeutics commences enrollment in its HPN-100 episodic hepatic encephalopathy trial

Hyperion Therapeutics, Inc. today announced that the first patient has been enrolled in its phase II clinical trial of investigational compound HPN-100 (glycerol phenylbutyrate).

3 Dec 2009

Patients with chronic hepatitis C can benefit by drinking coffee

Patients with chronic hepatitis C and advanced liver disease who drink three or more cups of coffee per day have a 53% lower risk of liver disease progression than non-coffee drinkers according to a new study led by Neal Freedman, Ph.D., MPH, from the National Cancer Institute (NCI).

20 Oct 2009

Higher rate of motor vehicle crashes in MHE patients

A recent study by Jasmohan Bajaj, M.D., and colleagues from Virginia Commonwealth University and McGuire VA Medical Center found that patients with cirrhosis of the liver who developed minimal hepatic encephalopathy (MHE) had a 16% rate of motor vehicle crashes compared to only 4% of those without MHE over one year.

10 Sep 2009

FDA accepts for filing Salix Pharmaceuticals' NDA for rifaximin tablets

Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) today announced the Food and Drug Administration (FDA) has accepted for filing and designated for Priority Review the Company’s New Drug Application (NDA) for rifaximin tablets 550 mg for the maintenance of remission of hepatic encephalopathy (HE). Additionally, the FDA has informed the Company of its plan to schedule an Advisory Committee meeting in late February 2010 to discuss the application.

25 Aug 2009

Cytokines lead to neurological and cognitive abnormalities and changes in heart rhythm in patients with cirrhosis

Liver cirrhosis is the seventh leading cause of death in the United States, taking 25,000 lives per year.

10 Feb 2009

Intra-arterial combination chemotherapy induces long-term survival for hepatocellular carcinoma

Portal venous tumor thrombus (PVTT) is a crucial factor that can worsen the prognosis of patients with hepatocellular carcinoma (HCC).

18 Oct 2007

The importance of the endocannabinoid-system

Cannabis (marijuana) is the most widely produced plant-based illicit drug worldwide and the illegal drug most frequently used in Europe.

15 Oct 2007

Ibuprofen improves cognitive function in rats induced with chronic liver failure

Cognitive impairment is one of the neurological effects in patients with hepatic encephalopathy (abnormal brain function due to severe liver disease).

2 Aug 2007

Racial disparities in treatment of patients with cirrhosis and complications of portal hypertension

African-American and Hispanic patients hospitalized for complications of portal hypertension were less likely to undergo a palliative shunt, prompt endoscopy, or liver transplantation compared to white patients, according to a new study in the May issue of Hepatology, a journal published by John Wiley & Sons on behalf of the American Association for the Study of Liver Diseases (AASLD).

2 May 2007

Lactulose improves quality of life in patients with cirrhosis who have minimal hepatic encephalopathy

A study on patients with cirrhosis who had minimal hepatic encephalopathy (MHE), a condition in which behavioral, psychological and neurological changes are associated with advanced liver disease, found that cognitive function and health related quality-of-life improved when they took lactulose. Lactulose is a drug used to help eliminate toxins such as ammonia that are normally cleared by the liver.

5 Mar 2007

Severity of liver disease not a reliable indicator of quality of life

A new study on the determination of how livers are allocated for transplants examined the relationship between liver disease severity and quality of life, and found that the commonly used model for liver allocation is not a reliable indicator of general quality of life.

24 Jan 2005