Rifaximin Monotherapy Research Articles

S1660 Rifaximin Monotherapy Is More Effective Than Lactulose Monotherapy for Reducing the Risk of Overt Hepatic Encephalopathy (OHE) Recurrence and All-Cause Mortality: An Analysis of Two Randomized Trials

S1660 Rifaximin Monotherapy Is More Effective Than Lactulose Monotherapy for Reducing the Risk of Overt Hepatic Encephalopathy (OHE) Recurrence and All-Cause Mortality: An Analysis of Two Randomized Trials

SAT-110-Impact of rifaximin monotherapy or rifamixin plus lactulose on markers of inflammation in patients with cirrhosis and a history of hepatic encephalopathy

SAT-110-Impact of rifaximin monotherapy or rifamixin plus lactulose on markers of inflammation in patients with cirrhosis and a history of hepatic encephalopathy

Assessment of Potential Impact of Demographic and Baseline Disease Characteristics on Rifaximin Monotherapy versus Lactulose Combination Therapy for the Prevention of Overt Hepatic Encephalopathy (OHE) Recurrence

Introduction: Rifaximin 550 mg is indicated for prevention of OHE recurrence in adults. A phase 4, open-label noninferiority trial evaluated the impact of baseline parameters on the efficacy of rifaximin alone vs rifaximin + lactulose for OHE recurrence prevention. Methods: Adults with cirrhosis and a previous OHE episode now in remission (Conn score ≤1) were randomized to rifaximin 550 mg BID alone or rifaximin 550 mg BID + lactulose (self-titrated; 2-3 soft stools/d) for 6 months. Breakthrough HE (Conn score ≥2) was monitored monthly. Time to onset of an OHE episode (primary endpoint) was assessed overall and by baseline parameters: age (< 65 y; ≥65 y), sex, race, prior lactulose use, diabetes status, MELD score, Conn score (0; 1), Child-Pugh class, asterixis grade (0; ≥1), duration of HE remission before study entry (≤90 days; >90 days), time since first diagnosis of advanced liver disease (< 50 months; 50 months), time since first diagnosis of HE (< 15 months; ≥15 months), number of HE episodes during past 6 months (1; >1), and cirrhosis etiology. Noninferiority was demonstrated if the upper limit 2-sided, 95% CI of hazard ratio (HR) of rifaximin to rifaximin + lactulose was < 1.6. Results: 113 patients were treated in the rifaximin alone group; 108 in rifaximin + lactulose group. Overall population mean MELD score was 11.9, 39.8% and 55.7% were Child-Pugh A and B, respectively, and baseline parameters were similar between groups. Breakthrough HE was reported in fewer patients in rifaximin + lactulose (13.9%) vs rifaximin alone (24.8%) groups; rifaximin + lactulose reduced the risk of breakthrough HE over 6 months to a greater degree (rifaximin alone vs combination HR, 2.0; 95% CI, 1.0-3.7; P=0.04). Demographic and baseline characteristics evaluated did not substantially alter the risk profile with rifaximin alone vs rifaximin + lactulose. In some subgroups (ie, Child-Pugh A [HR, 0.7; 95% CI, 0.2-2.4; P=0.6], remission duration >90 days [HR, 0.9; 95% CI, 0.4-2.1; P=0.7], prior 6-month HE episodes >1 [HR, 0.9; 95% CI, 0.3-2.7; P=0.9]), rifaximin alone reduced the risk of breakthrough HE to a greater degree than rifaximin + lactulose (ie, HR < 1); however, differences were not significant. Conclusion: Rifaximin + lactulose therapy appears to be consistently efficacious in prevention of OHE recurrence vs rifaximin alone and was unaltered by baseline characteristics evaluated. These data support the generalizability of the primary endpoint results.

PWE-047 Metronidazole is A Less Effective Therapy for Small Intestinal Bacterial Overgrowth

Introduction Choice of antibiotic treatment in patients who test positively for Small Intestinal Bacterial Overgrowth (SIBO) can be difficult. No controlled trial has examined the clinical efficacy of antibiotics in SIBO. This study aimed to identify which antibiotics are the most effective in treating SIBO in a real world retrospective cohort. Methods 520 adult patients (360 female, 160 male, mean age 49) who underwent hydrogen and glycocholate-methane breath tests for a suspicion of SIBO between the dates 01/01/2010 and 31/12/2013 were evaluated. The clinical information of patients who tested positively in both tests was recorded. Information was also gathered as to the antibiotic they were prescribed and whether they received symptomatic benefit from their treatment. Results A total of 90 patients who tested positive were prescribed antibiotics (59 female, 31 male, mean age 56). 69 (76.7%) of these patients benefitted from their management. 32 patients who tested positive were given cyclical antibiotics. The efficacy of cyclical antibiotics compared with the combined efficacy rates of other antibiotic regimes in treating patients with a positive breath test result was 93.8%. (93.8% vs 67.2%, Chi-square = 8.1, p = 0.004). 15 patients who tested positive were given rifaximin. The efficacy of rifaximin in treating patients with a positive breath test result compared with the combined efficacy of other antibiotic regimes was 80%. (80% vs 76% Chi-square = 0.112, p = 0.738). 18 patients who tested positive were given metronidazole. The efficacy of metronidazole in treating patients who tested positive in the breath tests compared with combined efficacy rates of other antibiotics was much lower at 50% (50% vs 83%, Chi-square = 8.9441, p = 0.0028). Conclusion Metronidazole appeared inferior to rifaximin monotherapy for treating SIBO. Cyclical antibiotics appeared most effective. These findings should be explored further in randomised controlled prospective trials to determine the optimal treatment regime. Disclosure of Interest None Declared

OC-029 Rifaximin Is Efficacious In The Treatment Of Chronic Overt Hepatic Encephalopathy: A Uk Liver Multi-centre Experience

IntroductionRifaximin-α is a non-absorbable antibiotic increasingly being used for the secondary prevention of recurrent overt hepatic encephalopathy (HE) in the UK. The therapeutic mechanism of rifaximin has yet to be...

Su1298 Improved Outcomes in Hepatic Encephalopathy Using Rifaximin Monotherapy Compared to Rifaximin and Lactulose Combination Therapy

Su1298 Improved Outcomes in Hepatic Encephalopathy Using Rifaximin Monotherapy Compared to Rifaximin and Lactulose Combination Therapy

Readmission Rates and Maintenance of Overt Hepatic Encephalopathy

Purpose: Hospitalizations according to Healthcare Costs and Utilization Project (HCUP) information demonstrates a continual increase in admissions for overt hepatic encephalopathy (HE). Rifaximin became the third FDA approved HE agent in 2010 by demonstrating marked decrease in hospitalizations and maintenance of HE remission. The purpose of this report is to evaluate the economic differences and primarily hospitalizations for various HE medical therapies. Methods: The medical charts of outpatient and hospitalized patients admitted for overt HE were examined from December 2010 to May 2012. Information collected included gender, age, ethnicity, MELD score, post discharge HE management protocol, HE hospitalization number (frequency), and time to readmission (days) (range), and health insurance coverage. All patients suffering from infection, renal failure, gastrointestinal bleeding or noncompliance was excluded. Group one was patients discharged with lactulose (LAC) while group two was discharge on rifaximin (RIF), while group three was discharged on RIF combined with LAC. The RFX dose was 1100 mg/day (550 mg twice per day); LAC dose was 30-120 cc/day adjusted to acquire two to three loose to soft bowel movements. Time from discharge to readmission, all patients were required to follow-up for discharge visit, maintain family support, and employment were measured. Patients were broken down into compliance or noncompliance with outpatient follow-up. Results: 87 patients were identified for compliance and 49 non-compliant. In the compliant group there were 51 males, 36 females, age (range 32-68), ethnicity (66% Caucasian, 14% African American, 17% Hispanic, 3% other), mean MELD 12.5 points (range 8-17). In the non- compliant group there were 29 males, 20 females, age (range 28-66), ethnicity (64% Caucasian, 18% African American, 18% Hispanic), mean MELD 11.5 points (range 6-18). In both patient populations group 1 had the highest charges, hospital readmissions, with overall costs differences by 46% and 9% compared to groups 2 and 1, respectively. Conclusion: The above results show that managing cirrhotics suffering HE is nearly 50% more cost efficient than lactulose monotherapy or combined therapy. Additionally, hospitalizations are less frequent while time to readmission favor rifaximin monotherapy as well. Disclosure: Dr. Guy W. Neff - Speaker's Bureau, Consultant, Grants.

Durability of Rifaximin Response in Hepatic Encephalopathy

To evaluate the durability of the response to rifaximin for treatment of hepatic encephalopathy (HE). The nonsystemic antibiotic rifaximin has been approved for maintenance of HE remission, and several studies have indicated the efficacy of rifaximin for acute HE; however, the duration of therapeutic response for >6 months remains unknown. Medical records of patients with cirrhosis who received rifaximin maintenance therapy for HE between January 2004 and May 2009 were reviewed. Model for end-stage liver disease (MELD) scores were obtained every 3 months during therapy. Of 203 patients with HE (Conn score ≥2), 149 received rifaximin monotherapy (400 to 1600 mg/d) and 54 received rifaximin (600 to 1200 mg/d) and lactulose (90 mL/d) dual therapy. Maintenance of HE remission for 1 year occurred in 81% and 67% of patients who received rifaximin monotherapy and rifaximin and lactulose dual therapy, respectively. Patient populations with a baseline mean MELD score ≤20 had few overt HE events, suggesting increased response to rifaximin in these patients. Rifaximin is effective for the management of HE in patients with cirrhosis, particularly in populations with MELD scores ≤20. Additional studies are needed to investigate the potential association between MELD scores and the efficacy of HE treatments.

Why Should Gastroenterologists Know About Fibromyalgia? Common Pathogenesis and Clinical Implications

Why Should Gastroenterologists Know About Fibromyalgia? Common Pathogenesis and Clinical Implications

Adjunctive Antibiotic Therapy with Rifaximin May Help Reduce Crohn’s Disease Activity

Enteric bacteria are thought to contribute to the pathogenesis of Crohn's disease, and antibiotics may be an effective therapy. This study examines the efficacy of the nonsystemic (<0.4% absorbed) antibiotic rifaximin for inducing remission in patients with Crohn's disease. Data from charts of patients with Crohn's disease who received rifaximin between 2001 and 2005 and had a Crohn's disease activity index score > or =220 at the time of rifaximin initiation were analyzed. The use of concomitant medications (e.g., steroids, anti-inflammatory agents) was allowed. In the 68 patient charts analyzed, the median duration of rifaximin treatment was 16.6 weeks, and the majority of patients (94%) received rifaximin 600 mg/day. Eighteen patients (26%) received rifaximin monotherapy, and 31 patients (46%) received concomitant steroids. The median baseline Crohn's disease activity index score at the time of rifaximin initiation was 265 (range, 220-460), and the mean duration of Crohn's disease was 17 years (range, 1-50 years). Crohn's disease remission occurred in 65% of patients. A 70% remission rate was achieved in patients who did not receive steroids, versus 58% in patients who received steroids. Clinical improvements continued 4 months after rifaximin initiation. Remission was achieved in 67% of patients who received rifaximin monotherapy. Rifaximin therapy was associated with clinical improvement in patients with Crohn's disease and may be a useful treatment option to consider for inducing and maintaining remission.

Rifaximin Monotherapy Was Effective in Patients with Newly Diagnosed Crohnʼs Disease

Rifaximin Monotherapy Was Effective in Patients with Newly Diagnosed Crohnʼs Disease

Newly diagnosed Crohnʼs cisease: case series of rifaximin monotherapy

Newly diagnosed Crohnʼs cisease: case series of rifaximin monotherapy

Restless Legs Syndrome in Patients with Irritable Bowel Syndrome: Response to Small Intestinal Bacterial Overgrowth Therapy

Small intestinal bacterial overgrowth (SIBO) occurs in irritable bowel syndrome (IBS) and fibromyalgia. Since restless legs syndrome (RLS) occurs with fibromyalgia, a link between IBS, SIBO, and RLS was studied. BS patients with abnormal lactulose breath tests received rifaximin 1,200 mg day(-1) for 10 days, followed by tegaserod 3 mg, long-term, and 1 month of zinc 220 mg day(-1) and once-daily probiotic (N = 11) or rifaximin monotherapy (N = 2). IBS symptom improvement was assessed after rifaximin. RLS symptoms, IBS symptoms, and overall IBS global improvement were assessed at last posttreatment visit: 8/10 patients were followed long-term (mean, 139 days; range, 54-450 days). Ten of 13 patients exhibited > or =80% improvement from baseline in RLS symptoms. Five maintained complete resolution of RLS symptoms. Global gastrointestinal symptom improvement was great (n = 6), moderate (n = 5), or mild (n = 2). This study suggests that SIBO associated with IBS may be a factor in some RLS patients and SIBO therapy provides long-term RLS improvement.

The cost‐effectiveness and budget impact of competing therapies in hepatic encephalopathy – a decision analysis

Treatment options for hepatic encephalopathy have disparate risks and benefits. Non-absorbable disaccharides and neomycin are limited by uncertain efficacy and common dose-limiting side effects. In contrast, rifaximin is safe and effective in hepatic encephalopathy, but is more expensive. We conducted a decision analysis to calculate the cost-effectiveness of six strategies in hepatic encephalopathy: (i) no hepatic encephalopathy treatment, (ii) lactulose monotherapy, (iii) lactitol monotherapy, (iv) neomycin monotherapy, (v) rifaximin monotherapy and (vi) up-front lactulose with crossover to rifaximin if poor response or intolerance of lactulose ('rifaximin salvage'). The primary outcome was cost per quality-adjusted life-year gained. Under base-case conditions, 'do nothing' was least effective and rifaximin salvage was most effective. Lactulose monotherapy was least expensive, and rifaximin monotherapy was most expensive. When balancing cost and effectiveness, lactulose monotherapy and rifaximin salvage dominated alternative strategies. Compared to lactulose monotherapy, rifaximin salvage cost an incremental US$2315 per quality-adjusted life-year-gained. The cost of rifaximin had to fall below US$1.03/tab in order for rifaximin monotherapy to dominate lactulose monotherapy. Rifaximin monotherapy is not cost-effective in the treatment of chronic hepatic encephalopathy at current average wholesale prices. However, a hybrid salvage strategy, reserving rifaximin for lactulose-refractory patients, may be highly cost-effective.

Is monotherapy with an oral antibiotic useful in reducing Crohnʼs disease activity?

Treatments for Crohn's disease (CD) are currently designed to control intestinal inflammation, including precipitators of the inflammatory cascade. Bacteria may play an important role in CD inflammation, and antibiotics may be useful in CD management. However, many clinicians avoid the long-term use of antibiotics, particularly in light of concerns with systemic toxicity and development of antibiotic resistance. Rifaximin is a nonabsorbed antibiotic with broad-spectrum antibacterial activity and a safety profile similar to placebo. Given these favorable characteristics, a retrospective chart review was conducted to examine the potential benefits of nonsystemic antibiotic monotherapy in CD management. A single-center chart review was conducted to identify patients with CD treated with rifaximin monotherapy from 2001 to 2005. Patients treated concomitantly with CD medications (eg, steroids) during antibiotic therapy were excluded from the analysis. Crohn's Disease Activity Index (CDAI) scores were determined retrospectively, with remission defined as CDAI score <150 and secondary efficacy endpoints determined as 70-point or 100-point reductions from baseline CDAI score. Data from 18 patients were analyzed, and the median baseline CDAI score was 237. Patients were treated with rifaximin 200 mg t.i.d. for a median of 13 weeks. Remission was achieved in 67% of 18 patients, and 70-point and 100-point reductions in CDAI score were observed in 50% and 39% of these patients, respectively. Seven patients (39%) exhibited disease of the small intestine only, and 5 of these (71%) achieved remission. This small observational study suggests that nonsystemic antibiotic therapy may provide clinically meaningful improvements in patients with CD. Nonsystemic antibiotics may play an important role in the management of patients with inflammatory bowel disease, and further investigations of monotherapy and adjunctive antibiotic therapy are warranted.