Drug intelligence / Profile preview

methylprednisolone + prednisolone

Development stage
Discontinued
Lead developer
Pfizer
Modality
Small Molecules
Administration
Intravenous, Oral
01

Overview

This refers to the specific corticosteroid regimen evaluated in the START (Steroids in the Treatment of Biliary Atresia) trial, a randomized, double-blind, placebo-controlled clinical trial sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The intervention consisted of a high-dose corticosteroid protocol initiated within 72 hours of Kasai portoenterostomy in infants with biliary atresia. The regimen involved intravenous methylprednisolone (4 mg/kg/day) for the first three days, followed by oral prednisolone (initially 4 mg/kg/day) with a gradual taper over a total of 14 weeks. The primary objective was to reduce postoperative inflammation and improve bile drainage and native liver survival. However, the trial (NCT00294684) concluded that the therapy did not significantly improve bile drainage or survival with the native liver at two years compared to placebo and was associated with an earlier onset of serious adverse events. Consequently, this corticosteroid protocol is not recommended for routine use in infants with biliary atresia following portoenterostomy.

Other names
corticosteroids-National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)-biliary atresiaSTART trial steroidsSTART trial corticosteroid regimencorticosteroids
02

Targets

GR (Glucocorticoid receptor)

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