PMID- 24672094 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20140327 LR - 20211021 IS - 0011-393X (Print) IS - 0011-393X (Linking) VI - 65 IP - 5 DP - 2004 Sep TI - Clinical effects of rifaximin in patientswith hepatic encephalopathy intolerant or nonresponsive to previous lactulose treatment: An open-label, pilot study. PG - 413-22 LID - 10.1016/j.curtheres.2004.10.002 [doi] AB - BACKGROUND: Hepatic encephalopathy (HE) is a metabolic-neurophysiologicsyndrome that occurs in patients with advanced hepatic disease. One of the main pathogenic mechanisms is represented by circulating toxins produced by the intestinal metabolism of nitrogenous compounds. The therapeutic approach to HE is mainly based on drugs that eliminate ammonia-producing bacteria. OBJECTIVES: The aim of this study was to evaluate the effects of the nonabsorbable antibiotic rifaximin in patients with HE who were intolerant or nonresponsive to treatment with an oral, nonabsorbable disaccharide (lactulose). METHODS: This uncontrolled, open-label, pilot study was conducted at the University of Bologna, Bologna, Italy. Patients aged >/= 18 years with histologically proven liver cirrhosis and HE were studied. All patients were intolerant or nonresponsive to previous treatment with lactulose. Rifaximin tablets were administered to patients at a dosage of 400 mg TID for 10 days. The portal systemic encephalopathy (PSE) index was evaluated at enrollment and at the end of the treatment period. Tolerability was assessed using hematology, biochemistry, and urinalysis and by recording adverse effects (AEs). RESULTS: Twenty-six patients (18 men, 8 women; mean [SD] age, 55.8 [8.0] years) were enrolled (intolerants, n = 17; nonresponders, n = 9). All patients completed the study. Significant improvement was shown in most of the 5 components of the PSE index after rifaximin administration in both intolerants and nonresponders. At the end of the 10-day treatment period, the PSE index was significantly reduced in both intolerants and nonresponders. Rifaximin was well tolerated; no clinically relevant AEs were observed during the treatment period. CONCLUSIONS: This pilot study of patients with liver cirrhosis and HE who were intolerant or nonresponsive to previous treatment with an oral, nonabsorbable disaccharide suggests that treatment with rifaximin may be considered as an adjuvant or an alternative treatment in reducing HE. FAU - Sama, Claudia AU - Sama C AD - Department of Internal Medicine and Gastroenterology, Alma Mater Studiorum,University of Bologna, Bologna, Italy. FAU - Morselli-Labate, Antonio Maria AU - Morselli-Labate AM AD - Department of Internal Medicine and Gastroenterology, Alma Mater Studiorum,University of Bologna, Bologna, Italy. FAU - Pianta, Paolo AU - Pianta P AD - Department of Internal Medicine and Gastroenterology, Alma Mater Studiorum,University of Bologna, Bologna, Italy. FAU - Lambertini, Laura AU - Lambertini L AD - Department of Internal Medicine and Gastroenterology, Alma Mater Studiorum,University of Bologna, Bologna, Italy. FAU - Berardi, Sonia AU - Berardi S AD - Department of Internal Medicine and Gastroenterology, Alma Mater Studiorum,University of Bologna, Bologna, Italy. FAU - Martini, Gabriella AU - Martini G AD - Department of Internal Medicine and Gastroenterology, Alma Mater Studiorum,University of Bologna, Bologna, Italy. LA - eng PT - Journal Article PL - United States TA - Curr Ther Res Clin Exp JT - Current therapeutic research, clinical and experimental JID - 0372621 PMC - PMC3964524 OTO - NOTNLM OT - antibiotics OT - disaccharides OT - drug therapy OT - hepatic encephalopathy OT - liver cirrhosis OT - rifaximin EDAT- 2004/09/01 00:00 MHDA- 2004/09/01 00:01 PMCR- 2004/09/01 CRDT- 2014/03/28 06:00 PHST- 2004/07/19 00:00 [accepted] PHST- 2014/03/28 06:00 [entrez] PHST- 2004/09/01 00:00 [pubmed] PHST- 2004/09/01 00:01 [medline] PHST- 2004/09/01 00:00 [pmc-release] AID - S0011-393X(04)80120-6 [pii] AID - 10.1016/j.curtheres.2004.10.002 [doi] PST - ppublish SO - Curr Ther Res Clin Exp. 2004 Sep;65(5):413-22. doi: 10.1016/j.curtheres.2004.10.002.