Rifaximin Treatment in Hepatic Encephalopathy

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1 Rifaximin Treatment in Hepatic Encephalopathy Bass NM, Mullen KD, Sanyal A et al. NEJM 362;12: Hina Ahmed, Pharm.D, ACPR, BCPS Clinical Pharmacist Toronto General Hospital

2 Rifaximin (Xifaxan ) Rifaximin is minimally absorbed antibiotic concentrated in gastrointestinal tract leading to minimal bacterial resistance Activity against aerobic and anaerobic grampositive and gram-negative bacteria Not available in Canada Approved by FDA in March 2010 for indication of hepatic encephalopathy

3 Hepatic Encephalopathy (HE) Complication of liver disease Neuropsychiatric syndrome Symptoms include: Deterioration in mental status Psychomotor dysfunction Impaired memory Increased reaction time Sensory abnormalities Poor concentration Coma (severe forms)

4 Diagnosis Impaired Mental Status Conn Score (West Haven Score) 0 = no personality and behavioral abnormality detected 1 = trivial lack of awareness, euphoria or anxiety, shortened attention span or impairment of ability to add or subtract 2 = lethargy, disorientation with respect to time, obvious personality change or inappropriate behavior 3 = somnolence, or semi stupor, responsiveness to stimuli, confusion, gross disorientation, or bizarre behavior 4 = coma Impaired Neuromotor Function Asterixis Severity Scale

5 Treatment Goal: Reduce nitrogenous load (ammonia) from gut Lactulose (cornerstone of therapy) Decrease ammonia absorption through cathartic effects and altering colonic ph Used for treatment and prevention of HE Neomycin, vancomycin, metronidazole Reduce ammonia-producing enteric bacteria Rifaximin previously used for treatment of HE

6 Study Design Phase 3 trial Double blind Placebo controlled RCT Superiority trial

7 Study Design Primary efficacy end point Time to first breakthrough HE episode Defined as increase in conn score of 0 or 1 to conn score > 2 OR conn score of unit increase asterixis grade Subgroup analysis done Secondary efficacy end point Time to first hospitalization involving HE

8 Study Design Inclusion criteria Age 18 y/o Two episodes of overt hepatic encephalopathy (conn score 2) associated with hepatic cirrhosis in last 6 months Model for End-Stage Liver Disease (MELD) scale < 25

9 Study Design Exclusion criteria Expectation of liver transplant < 1 month after screening visit Chronic RF/ CKD (SCr > 177 mmol/l) Respiratory insufficiency Anemia (Hb < 80 g/l) Sodium < 125 mmol/l Potassium < 2.5 mmol/l Calcium > 2.5 mmol/l Intercurrent infection Active spontaneous bacterial peritonitis (SBP) Conditions precipitating hepatic encephalopathy GI hemorrhage <3 months of screening visit Placement of portosystemic shunt < 3 months of screening visit Placement of transjugular intrahepatic portosystemic shunt < 3 months of screening visit

10 Study Design Excluded previous episodes of HE due to GI hemorrhage requiring 2 units of blood if precipitated by: Medication use Renal failure requiring dialysis Injury to CNS

11 Study Design Screening visit Observation period Enrollment visit Day 0 1:1 randomization Rifaximin 550mg po bid or placebo Concomitant use of lactulose allowed Treatment continued for 6 months or until first breakthrough HE episode or stopped for other reason 6 month treatment phase

12 Treatment Phase Clinic visit: 7d, 14d then q2weeks until day 168 Each visit: recorded conn score, asterixis grade Telephone monitoring on non-clinic visit weeks Optional visits q2weeks until day 154 Treatment stopped with first breakthrough HE episode

13 Study Design

14 Study Protocol Designed by Salix pharmaceuticals and academic authors Data from each site analyzed by Salix pharmaceuticals representatives Editorial representative assisted in revision of drafts Paid by Salix Pharmaceuticals

15 Statistical Analysis Intent to treat population Cox-proportional hazards model 2 sided test Significance level = 0.05 Kaplan-Meier to estimate proportion of patients having breakthrough episodes at successive points Power 80 % (N = 100 per group) Safety data descriptive statistics

16

17 Results HE breakthrough episode 22.1% rifaximin vs. 45.9% placebo (p<0.001) Relative risk reduction 58% NNT = 4 Hospitalization 13.6% rifaximin vs. 22.6% placebo (p = 0.01) Relative risk reduction 50% NNT = 9 Safety Incidence of adverse events similar

18 Results

19 Results

20 Results

21 Mean duration Results Rifaximin: days Placebo: days Similar patients receiving lactulose Rifaximin 91.4% Placebo 91.2% Rate of compliance Rifaximin 84.3 % Placebo 84.9 %

22 Conclusion Over 6 month period, rifaximin maintained remission from HE more effectively than placebo Rifaximin significantly reduced the risk of hospitalization involving HE

23 Limitations Study title misleading Sponsored by Salix pharmaceuticals Six month duration Not a placebo controlled trial Over 90% patients in each group received lactulose concomitantly Combination of rifaximin and lactulose superior to lactulose alone Excluded patients with infection and GI bleed that my precipitate episodes of HE

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