Independence From Parenteral Nutrition and Intravenous Fluid Support During Treatment With Teduglutide Among Patients With Intestinal Failure Associated With Short Bowel Syndrome

Abstract

Background: In phase III clinical studies, treatment with teduglutide was associated with clinically meaningful reductions (≥20% from baseline) in parenteral support (PS; parenteral nutrition and/or intravenous fluids) requirements in adult patients with intestinal failure associated with short bowel syndrome (SBS-IF). This analysis reports clinical characteristics of patients who achieved complete independence from PS during teduglutide treatment. Materials and Methods: Post hoc analysis of adult patients who achieved complete PS independence during treatment with teduglutide 0.05 mg/kg/d. Data were pooled from 5 teduglutide clinical trials (2 phase III placebo-controlled trials [NCT00081458 and NCT00798967] and their respective extension studies [NCT00172185, NCT00930644, NCT01560403]). Descriptive statistics were used; no between-group comparisons were performed because of the small sample size and lack of comparator. Results: Of 134 patients, 16 gained oral or enteral autonomy after a median of 5 years of PS dependence and 89 weeks of teduglutide treatment. Demographic and baseline disease characteristics varied among patients (median age, 55 years; 50% men; median baseline PS volume, 5.1 L/wk; median residual small intestine length, 52.5 cm). Most patients who achieved PS independence had colon-in-continuity; however, there was no significant difference in the frequency of PS independence among patients who maintained colon-in-continuity vs those who did not. Conclusion: Findings from this post hoc analysis suggest that oral or enteral autonomy is possible for some patients with SBS-IF who are treated with teduglutide, regardless of baseline characteristics and despite long-term PS dependence.

GLP-2 analog teduglutide significantly reduces need for parenteral nutrition and stool frequency in a real-life setting

“…Total amount of intravenous fluid and calorie uptake per week was significantly reduced over time, but it took longer than previously reported in a randomized and controlled clinical trial. 26 Interestingly, as reported previously, 32 baseline characteristics for amount of parenteral support before the start of treatment did not strictly determine the effect of teduglutide. Patients initially on daily parenteral support showed a strong improvement after treatment over 1 year.…”

“…This finding is consistent with recently published real-life data 29 as well as the post hoc analysis of the phase III placebo-controlled trials. 30 This observation is supported by the high physiological expression of the GLP-2 receptor in the colon.…”

Parenteral and Enteral Nutrition—From Hospital to Home: Will It Be Covered?

“…A review looking at studies that included a total of 134 patients on HPN treated with teduglutide showed that 12% of HPN patients were able to completely discontinue their PN and others were able to decrease the number of days they needed PN 64 . While it potentially improves quality of life for these patients, if the patients no longer meet the Medicare guidelines for the number of calories needed to come from HPN or are able to decrease the number of days of infusion, as has been shown, it may put coverage for HPN in jeopardy 70 , 71 …”

“…64 While it potentially improves quality of life for these patients, if the patients no longer meet the Medicare guidelines for the number of calories needed to come from HPN or are able to decrease the number of days of infusion, as has been shown, it may put coverage for HPN in jeopardy. 70,71…”

Short bowel syndrome: influence of nutritional therapy and incretin GLP1 on bone marrow adipose tissue

“…SBS shares a common trait with AN: both are bone catabolic disorders. On the other hand, while AN is a condition of self‐imposed caloric restriction, in SBS, individuals receive calorie replacement through parenteral and enteral nutrition . No previous study that we are aware of has assessed the relationship between MAT and bone mass in individuals taking artificial nutrition.…”