Rifaximin reduces risk for overt hepatic encephalopathy recurrence by 60% vs. lactulose
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Key takeaways:
- Fewer patients treated with rifaximin had an overt hepatic encephalopathy episode vs. those treated with lactulose (23.2% vs. 49%).
- Mortality rate also was lower in the rifaximin group (1.6% vs. 4.8%).
PHILADELPHIA — Rifaximin monotherapy reduced episode recurrence and “may confer” a survival benefit compared with lactulose monotherapy among patients with cirrhosis and a history of overt hepatic encephalopathy, according to a presenter.
“Lactulose monotherapy is recommended as secondary prophylaxis after an initial overt [hepatic encephalopathy (HE)] episode,” Jasmohan S. Bajaj, MD, MS, FACG, professor in the division of gastroenterology, hepatology and nutrition at Virginia Commonwealth University School of Medicine, said at the ACG Annual Scientific Meeting. “Rifaximin is only recommended as an add-on therapy where additional episodes occur.
“Nonadherence to lactulose can precipitate HE recurrence. For those who have actually dealt with patients dealing with lactulose, it has a plethora of side effects ... This ensures that we may need another alternative management strategy.”
In a post-hoc analysis of two randomized trials, Bajaj and colleagues compared the safety and efficacy of lactulose and rifaximin monotherapies among 270 patients (mean age, about 57 years; 60% men; median MELD score, 12) with cirrhosis and a history of overt HE. Patients received either rifaximin 550 mg twice daily (n = 125) or lactulose, titrated to two to three soft stools per day, with placebo (n = 145). The primary endpoint was time to first breakthrough overt HE episode.
At baseline, 51.2% and 46.2% in each group, respectively, had Child-Pugh class B cirrhosis.
According to study results, the incidence of an overt HE episode during 6 months of treatment was significantly lower among patient treated with rifaximin (23.2% vs. 49%; P < .0001), with a 60% decreased risk for a breakthrough episode and a number needed to treat of four vs. lactulose monotherapy.
In addition, Bajaj noted a “statistically significantly lower” time to first breakthrough overt HE episode with rifaximin (HR = 0.4; 95% CI, 0.26-0.62).
Mortality rates were 1.6% vs. 4.8% (P < .001), with a number needed to treat of 19 (HR = 0.048; 95% CI, 0.01-0.29). Through up to 16 days after treatment, 1.6% and 6.9% of patients died, of whom two, nine and one had Child-Pugh class A, B and C, respectively, at baseline. HE recurrence prompted study discontinuation among 36% in the rifaximin group vs. 62.1% in the lactulose group.
“Significantly fewer overt hepatic encephalopathy recurrence episodes were reported with rifaximin monotherapy compared with lactulose monotherapy in patients with a history of overt hepatic encephalopathy,” Bajaj said. “Rifaximin treatment may confer a survival benefit, it was well-tolerated and could be an appropriate management in select patient populations.”
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Bajaj JS, et al. 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. Presented at: ACG Annual Scientific Meeting; Oct. 25-30, 2024; Philadelphia (hybrid meeting).
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