Teduglutide improves liver chemistries in short bowel syndrome–associated intestinal failure: Post hoc analysis

Abstract

AbstractBackgroundChronic hepatic complications are common in patients with short bowel syndrome–associated intestinal failure (SBS‐IF). Teduglutide, a glucagon‐like peptide‐2 analogue, demonstrated efficacy in reducing parenteral nutrition and/or intravenous fluid dependence among patients with SBS‐IF in phase 3 clinical studies.MethodsThis was a post hoc analysis of pooled data from two separate randomized, double‐blind, placebo‐controlled, multinational phase 3 clinical studies. Adult patients with SBS‐IF with parenteral nutrition and/or intravenous fluid dependence without liver disease at baseline were randomized to treatment with the glucagon‐like peptide‐2 analogue teduglutide (0.05 or 0.10 mg/kg/day) or placebo subcutaneously once daily for 24 weeks. Mixed‐effects models assessed the baseline predictors of change in liver chemistries.ResultsBetween baseline and week 24, teduglutide treatment (n = 109) was associated with least squares mean reductions in aspartate aminotransferase (–7.51 IU/L; P = 0.014), alanine aminotransferase (–12.15 IU/L; P = 0.002), and bilirubin (–5.03 µmol/L [–0.057 mg/dl]; P < 0.001) compared with that of the placebo (n = 59). These values were independent of reductions in parenteral nutrition and/or intravenous fluid dependence.ConclusionTeduglutide treatment was associated with reductions in liver chemistries by week 24, which is beneficial for patients with SBS‐IF beyond improvements in parenteral nutrition and/or intravenous fluid dependence. Future studies should examine how long‐term teduglutide might mitigate the risk of liver disease in patients with SBS‐IF.