Targaxan: a new option for hepatic encephalopathy

Norgine has launched a new version of the antibacterial rifaximin (Targaxan) to prevent the recurrence of episodes of hepatic encephalopathy.

Targaxan (rifaximin) is the first product in the UK to be licensed specifically for the reduction in recurrence of episodes of overt hepatic encephalopathy.
Targaxan (rifaximin) is the first product in the UK to be licensed specifically for the reduction in recurrence of episodes of overt hepatic encephalopathy.

PHARMACOLOGY

Rifaxmin is a rifamycin antibacterial. It is thought to inhibit the division of urea-deaminating bacteria in the gut, thereby reducing the production of ammonia and other compounds that are believed to be important to the pathogenesis of hepatic encephalopathy.1

CLINICAL STUDIES

The efficacy and safety of rifaximin in the treatment of hepatic encephalopathy were confirmed in a randomised, double-blind, placebo-controlled study in 299 patients who were in remission from the condition.2

To be eligible, patients must have experienced at least two episodes of overt hepatic encephalopathy associated with hepatic cirrhosis in the previous six months. Patients were excluded if they were expected to receive a liver transplant within one month of the screening visit or if they had conditions known to precipitate hepatic encephalopathy (including gastrointestinal haemorrhage or portosystemic shunt) within three months of the screening visit.2

Investigators randomly assigned patients to receive either rifaximin 550mg twice daily or placebo for six months, or until discontinuation due to first breakthrough episode of hepatic encephalopathy or another reason. Concomitant lactulose was permitted during the study and was used by around 91% of patients in each arm.2

Significantly fewer HE episodes in rifaximin group

Rifaximin significantly reduced the risk of an episode of overt hepatic encephalopathy over six months compared with placebo (HR 0.42, 95% CI 0.28–0.64, p<0.001). Breakthrough episodes occurred in 22.1% of patients in the rifaximin group compared with 45.9% of those in the placebo group.2

Overall, 13.6% of patients in the rifaximin group had an episode that required hospitalisation compared with 22.6% of those in the placebo group (HR 0.50, 95% CI 0.29–0.87, p=0.01).2

Similar adverse event profile to placebo

The incidence of adverse events, including serious events, was similar in the two groups. Two cases of Clostridium difficile infection were observed in the rifaximin group (none were reported in the placebo group) but both were successfully treated while continuing study medication.2

Rifaximin is also available as Xifaxanta for the treatment of travellers’ diarrhoea.

References:

1.    Targaxan Summary of Product Characteristics, January 2013.
2.    Bass NM et al. N Engl J Med 2010; 362: 1071–81.

View Targaxan drug record

Further information:  Norgine Pharmaceuticals Ltd

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