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Steroid treatment associated with earlier onset of adverse events in children with biliary atresia

This week's publication of the Journal of the American Medical Association investigates the use of corticosteroids after hepatoportoenterostomy for bile drainage in infants with biliary atresia.

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Biliary atresia is the most common cause of end-stage liver disease in children.

Controversy exists as to whether use of steroids after hepatoportoenterostomy improves clinical outcome.

Dr Jorge Bezerra and colleagues determined whether the addition of high-dose corticosteroids after hepatoportoenterostomy is superior to surgery alone in improving biliary drainage and survival with the native liver.

The research team performed a multicenter, double-blind Steroids in Biliary Atresia Randomized Trial (START) in 140 infants between 2005 and 2011 in the United States.

The team's follow-up ended in January 2013.

Transplant-free survival was about 59% in the steroids group
Journal of the American Medical Association

Participants were randomized to receive intravenous methylprednisolone, and oral prednisolone followed by a tapering protocol for 9 weeks or placebo initiated within 72 hours of hepatoportoenterostomy.

The team's primary end point was the percentage of participants with a serum total bilirubin level of less than 1.5 mg/dL with his/her native liver at 6 months posthepatoportoenterostomy.

Secondary outcomes included survival with native liver at 24 months of age and serious adverse events.

The researchers found that proportion of participants with improved bile drainage was not statistically significantly improved by steroids at 6 months posthepatoportoenterostomy of placebo group.

The team observed that the adjusted absolute risk difference was 9%.

Transplant-free survival was about 59% in the steroids group, and in the placebo group at 24 months of age.

The team noted that the percentage of participants with serious adverse events was 81% of the steroids group, and 80% of the placebo group.

However, participants receiving steroids had an earlier time of onset of their first serious adverse event by 30 days posthepatoportoenterostomy.

Dr Bezerra's team concludes, "Among infants with biliary atresia who have undergone hepatoportoenterostomy, high-dose steroid therapy following surgery did not result in statistically significant treatment differences in bile drainage at 6 months, although a small clinical benefit could not be excluded."

"Steroid treatment was associated with earlier onset of serious adverse events in children with biliary atresia."

JAMA 2014;311(17):1750-1759
08 May 2014

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