Rifaximin Is Safe and Well Tolerated for Long-term Maintenance of Remission From Overt Hepatic Encephalopathy

Clinical Gastroenterology and Hepatology

Volumn 12, Issue 8, 2014, Pages

  Mullen, Kevin D ^a   Sanyal, Arun J ^b   Bass, Nathan M ^c   Poordad, Fred F ^d   Sheikh, Muhammad Y ^c   Frederick, R Todd ^e   Bortey, Enoch ^f   Forbes, William P ^f  

^a CASE WESTERN RESERVE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b VIRGINIA COMMONWEALTH UNIVERSITY   (United States)

^c UNIVERSITY OF CALIFORNIA   (United States)

^d UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO   (United States)

^e CALIFORNIA PACIFIC MEDICAL CENTER   (United States)

^f Salix a Division of Valeant Pharmaceuticals North America LLC   (United States)

Author keywords

Antimicrobial Agent; Chronic Liver Disease; Cirrhosis; Xifaxan

Indexed keywords

LACTULOSE; PLACEBO; RIFAXIMIN; GASTROINTESTINAL AGENT; RIFAMYCIN;

ABDOMINAL DISTENSION; ABDOMINAL PAIN; ADULT; ANTIBIOTIC RESISTANCE; ARTICLE; ASCITES; CLINICAL LABORATORY; CLOSTRIDIUM; CONSTIPATION; CONTROLLED STUDY; DIARRHEA; DIVERTICULOSIS; DRUG EXPOSURE; DRUG SAFETY; DRUG SCREENING; DRUG TOLERANCE; ESOPHAGUS HEMORRHAGE; ESOPHAGUS VARICES; FEMALE; GASTRITIS; GASTROINTESTINAL DISEASE; GASTROINTESTINAL HEMORRHAGE; HEPATIC ENCEPHALOPATHY; HOSPITALIZATION; HUMAN; LIVER CIRRHOSIS; MAJOR CLINICAL STUDY; MALE; MELENA; NAUSEA; RANDOMIZED CONTROLLED TRIAL; RECTUM HEMORRHAGE; REMISSION; STOMACH HEMORRHAGE; SURVIVAL; TREATMENT OUTCOME; UPPER GASTROINTESTINAL BLEEDING; VOMITING; ADOLESCENT; AGED; CLINICAL TRIAL; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; LONGITUDINAL STUDY; MIDDLE AGED; PHASE 3 CLINICAL TRIAL; STATISTICS AND NUMERICAL DATA; VERY ELDERLY; YOUNG ADULT; CLOSTRIDIUM DIFFICILE INFECTION; DRUG TOLERABILITY; LONG TERM CARE; MAINTENANCE THERAPY; MODEL FOR END STAGE LIVER DISEASE SCORE; MULTICENTER STUDY; OPEN STUDY; OVERT HEPATIC ENCEPHALOPATHY; TREATMENT RESPONSE;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; FEMALE; GASTROINTESTINAL AGENTS; HEPATIC ENCEPHALOPATHY; HOSPITALIZATION; HUMANS; LONGITUDINAL STUDIES; MALE; MIDDLE AGED; PLACEBOS; RIFAMYCINS; YOUNG ADULT;

EID: 84904384671     PISSN: 15423565     EISSN: 15427714     Source Type: Journal    
DOI: 10.1016/j.cgh.2013.12.021     Document Type: Article

References (30)

1. Bajaj J.S., Wade J.B., Gibson D.P., et al. The multi-dimensional burden of cirrhosis and hepatic encephalopathy on patients and caregivers. Am J Gastroenterol 2011, 106:1646-1653.
2. Poordad F.F. Review article: the burden of hepatic encephalopathy. Aliment Pharmacol Ther 2007, 25(Suppl 1):3-9.
3. Nguyen G.C., Segev D.L., Thuluvath P.J. Nationwide increase in hospitalizations and hepatitis C among inpatients with cirrhosis and sequelae of portal hypertension. Clin Gastroenterol Hepatol 2007, 5:1092-1099.
4. Stewart C.A., Malinchoc M., Kim W.R., et al. Hepatic encephalopathy as a predictor of survival in patients with end-stage liver disease. Liver Transpl 2007, 13:1366-1371.
5. Bustamante J., Rimola A., Ventura P.J., et al. Prognostic significance of hepatic encephalopathy in patients with cirrhosis. JHepatol 1999, 30:890-895.
6. Als-Nielsen B., Gluud L.L., Gluud C. Non-absorbable disaccharides for hepatic encephalopathy: systematic review of randomised trials. BMJ 2004, 328:1046.
7. Morgan M.Y., Blei A., Grüngreiff K., et al. The treatment of hepatic encephalopathy. Metab Brain Dis 2007, 22:389-405.
8. Phongsamran P.V., Kim J.W., Cupo Abbott J., et al. Pharmacotherapy for hepatic encephalopathy. Drugs 2010, 70:1131-1148.
9. Sharma B.C., Sharma P., Agrawal A., et al. Secondary prophylaxis of hepatic encephalopathy: an open-label randomized controlled trial of lactulose versus placebo. Gastroenterology 2009, 137:885-891.
10. Neff G. Factors affecting compliance and persistence with treatment for hepatic encephalopathy. Pharmacotherapy 2010, 30:22S-27S.
11. Gillis J.C., Brogden R.N. Rifaximin. A review of its antibacterial activity, pharmacokinetic properties and therapeutic potential in conditions mediated by gastrointestinal bacteria. Drugs 1995, 49:467-484.
12. Ruiz J., Mensa L., Pons M.J., et al. Development of Escherichia coli rifaximin-resistant mutants: frequency of selection and stability. JAntimicrob Chemother 2008, 61:1016-1019.
13. Bass N.M., Mullen K.D., Sanyal A., et al. Rifaximin treatment in hepatic encephalopathy. NEngl J Med 2010, 362:1071-1081.
14. Gehan E.A. The evaluation of therapies: historical control studies. Stat Med 1984, 3:315-324.
15. Pocock S.J. The combination of randomized and historical controls in clinical trials. JChronic Dis 1976, 29:175-188.
16. Guidance for industry: E 10: choice of control group and related issues in clinical trials 2001, U.S., Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER), US Food and Drug Administration Center for Biologics Evaluation and Research, Rockville, MD.
17. Sanyal A., Younossi Z.M., Bass N.M., et al. Randomised clinical trial: rifaximin improves health-related quality of life in cirrhotic patients with hepatic encephalopathy-a double-blind placebo-controlled study. Aliment Pharmacol Ther 2011, 34:853-861.
18. Bajaj J.S., Sanyal A.J., Bell D., et al. Predictors of the recurrence of hepatic encephalopathy in lactulose-treated patients. Aliment Pharmacol Ther 2010, 31:1012-1017.
19. Leevy C.B., Phillips J.A. Hospitalizations during the use of rifaximin versus lactulose for the treatment of hepatic encephalopathy. Dig Dis Sci 2007, 52:737-741.
20. Neff G.W., Kemmer N., Zacharias V.C., et al. Analysis of hospitalizations comparing rifaximin versus lactulose in the management of hepatic encephalopathy. Transplant Proc 2006, 38:3552-3555.
21. Bajaj J.S., Schubert C.M., Heuman D.M., et al. Persistence of cognitive impairment after resolution of overt hepatic encephalopathy. Gastroenterology 2010, 138:2332-2340.
22. Strauss E., de Fátima Gomes de Sá Ribeiro M. Bacterial infections associated with hepatic encephalopathy: prevalence and outcome. Ann Hepatol 2003, 2:41-45.
23. Arvaniti V., D'Amico G., Fede G., et al. Infections in patients with cirrhosis increase mortality four-fold and should be used in determining prognosis. Gastroenterology 2010, 139:1246-1256.
24. Vanjak D., Girault G., Branger C., et al. Risk factors for Clostridium difficile infection in a hepatology ward. Infect Control Hosp Epidemiol 2007, 28:202-204.
25. Tandon P., Delisle A., Topal J.E., et al. High prevalence of antibiotic-resistant bacterial infections among patients with cirrhosis at a US liver center. Clin Gastroenterol Hepatol 2012, 10:1291-1298.
26. Leise M.D., Pedersen R., Kamath P.S., et al. Impact of rifaximin treatment on survival in patients with end-stage liver disease (abstr). Hepatology 2010, 62(Suppl):311A.
27. Vlachogiannakos J., Viazis N., Vasianopoulou P., et al. Long-term administration of rifaximin improves the prognosis of patients with alcohol-related decompensated alcoholic cirrhosis. JGastroenterol Hepatol 2013, 28:450-455.
28. Vlachogiannakos J., Saveriadis A.S., Viazis N., et al. Intestinal decontamination improves liver haemodynamics in patients with alcohol-related decompensated cirrhosis. Aliment Pharmacol Ther 2009, 29:992-999.
29. Kalambokis G., Mouzaki A., Rodi M., et al. Rifaximin improves thrombocytopenia in patients with alcoholic cirrhosis in association with reduction in endotoxaemia. Liver Int 2012, 32:467-475.
30. Kalambokis G., Tsianos E.V. Endotoxaemia in the pathogenesis of cytopenias in liver cirrhosis. Could oral antibiotics raise blood counts?. Med Hypotheses 2011, 76:105-109.