"TIPS is a very effective treatment of portal hypertension-related complications of cirrhosis, but the main drawback of this procedure is the high incidence of post-TIPS HE that limits its use," Dr. Christophe Bureau of the University Hospital of Toulouse and Toulouse III Paul Sabiter University told Reuters Health by email. "Considering the safety profile of rifaximin and its ability to reduce the risk of post-TIPS HE, it should be used in patients treated with TIPS."
As reported in the Annals of Internal Medicine, Dr. Bureau and colleagues randomly assigned 197 patients with cirrhosis (mean age, about 60; about 78% men) undergoing TIPS for intractable ascites or prevention of variceal rebleeding to receive rifaximin (600 mg twice daily) or placebo, beginning 14 days before TIPS and continuing for 168 days after the procedure.
The primary efficacy end point was HE incidence within the post-TIPS follow-up period.
An episode of overt HE occurred in 34% of patients in the rifaximin group compared to 53% in the placebo group (odds ratio, 0.48). The median duration of the episode was four days.
No between-group significant differences were seen in the incidence of adverse events or in transplant-free survival.
The authors note that the study's conclusion applies mainly to patients with alcoholic cirrhosis, who made up most (86%) of the study population.
Dr. Bureau said, "Studies are ongoing for a better understanding of the actions of rifaximin and whether it could allow us to broaden the indication for TIPS. Further studies are also needed to know if rifaximin must be continued for a longer period than six months."
Dr. Sonja Olsen, a transplant hepatologist at NYU Langone Health in New York City, told Reuters Health by email, "Post-TIPS encephalopathy is a major problem and often requires hospitalization and an extensive workup for other causes of the encephalopathy. Thus, the ability to reduce the incidence of a first episode of HE in this high-risk population is significant. The findings are promising particularly because rifaximin is a very well tolerated medication."
"The rates of HE seen in the study (34% and 53%) are higher than we typically see," she noted. "This does not seem to be related to how they assessed HE. One important distinction with this trial is the use of rifaximin two weeks PRIOR to the TIPS, which is novel and makes sense given its mechanism of action. One other point is the fact that the patients studied were low MELD, which may not be representative of the average patient getting a TIPS."
Further, she said, "Rifaximin is a costly medication and it typically requires prior authorization. This will need to be addressed and there may be barriers to access based on the payor."
That said, she added, "assuming patients have access to rifaximin, (the study) will likely change practice, as preventing hospitalizations for HE post-TIPS will dramatically improve quality of life for patients and their families."
SOURCE: https://bit.ly/3rmN0Wd Annals of Internal Medicine, online February 1, 2021.
By Marilynn Larkin
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