Determinants of Quality of Life in Patients With Intestinal Failure Receiving Long‐Term Parenteral Nutrition Using the SF‐36 Questionnaire: A German Single‐Center Prospective Observational Study

Blüthner, Elisabeth; Bednarsch, Jan; Stockmann, Martin; Karber, Mirjam; Pevny, Sophie; Maasberg, Sebastian; Gerlach, Undine; Pascher, Andreas; Wiedenmann, Bertram; Pratschke, Johann; Pape, Ulrich‐Frank

doi:10.1002/jpen.1531

Cited by 33 publications

(85 citation statements)

References 42 publications

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“…PS reductions in response to treatment with teduglutide are expected to reduce the long-term risks associated with PS and may also improve quality of life of children with SBS-IF. 7,8,22…”

Section: Discussionmentioning

confidence: 99%

“…[1][2][3] Enhancing intestinal adaptation minimizes dependence on PS, thereby reducing the risk of complications [4][5][6] and potentially improving quality of life. 7,8 Glucagon-like peptide-2 (GLP-2), a hormone secreted by enteroendocrine L cells in the distal ileum and proximal colon in response to the presence of unabsorbed luminal nutrients, 9,10 is a key component of the adaptive response to intestinal malabsorption. [9][10][11][12] Teduglutide, a recombinant human GLP-2 analogue, is approved in the United States and Europe for the treatment of patients ࣙ1 year of age with SBS-IF at a dose of 0.05 mg/kg administered subcutaneously once daily.…”

Section: Introductionmentioning

confidence: 99%

“…Long‐term administration of parenteral support (PS; parenteral nutrition and/or intravenous fluids) is life‐saving but associated with potentially life‐threatening complications, including IF‐associated liver disease, central line–associated blood stream infections, and central venous thrombosis . Enhancing intestinal adaptation minimizes dependence on PS, thereby reducing the risk of complications and potentially improving quality of life …”

Section: Introductionmentioning

confidence: 99%

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Safety and Efficacy of Teduglutide in Pediatric Patients With Intestinal Failure due to Short Bowel Syndrome: A 24‐Week, Phase III Study

Kocoshis

Merritt

Hill

et al. 2019

J Parenter Enteral Nutr

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Background: This study evaluated the safety and efficacy of teduglutide in pediatric patients with short bowel syndrome-associated intestinal failure (SBS-IF). Methods: A 24-week, phase III trial with 2 randomized, double-blind teduglutide dose groups and a nonblinded standard of care (SOC) arm was used; patients received 0.025 mg/kg or 0.05 mg/kg teduglutide once daily. Safety end points included treatment-emergent adverse events (TEAEs) and growth parameters. The primary efficacy/pharmacodynamic end point was the number of patients who achieved a ࣙ20% reduction in parenteral support (PS) from baseline at week 24. Results: All 59 enrolled patients completed the study (0.025 mg/kg, n = 24; 0.05 mg/kg, n = 26; SOC, n = 9). Baseline demographics and disease characteristics were comparable among groups. TEAEs were reported by 98% and 100% of patients in the teduglutide and SOC groups, respectively. The most common TEAEs in the teduglutide-treated groups were pyrexia and vomiting. The primary end point was achieved by 13 (54.2%), 18 (69.2%), and 1 (11.1%) patients who received 0.025 mg/kg teduglutide, 0.05 mg/kg teduglutide, and SOC, respectively (P < 0.05 vs SOC). Both 0.025-mg/kg and 0.05-mg/kg teduglutide groups showed clinically significant reductions in PS volume (P < 0.05 vs SOC), PS calories, days per week and hours per day of PS infusions, and increases in enteral nutrition and plasma citrulline at week 24 compared with baseline. Two (8.3%, 0.025 mg/kg teduglutide) and 3 patients (11.5%, 0.05 mg/kg teduglutide) achieved enteral autonomy. Conclusion: The safety profile of teduglutide was similar to that reported previously in children and adults. Treatment with teduglutide was associated with significant reductions in PS for pediatric patients with SBS-IF over 24 weeks.

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“…PS reductions in response to treatment with teduglutide are expected to reduce the long-term risks associated with PS and may also improve quality of life of children with SBS-IF. 7,8,22…”

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Safety and Efficacy of Teduglutide in Pediatric Patients With Intestinal Failure due to Short Bowel Syndrome: A 24‐Week, Phase III Study

Kocoshis

Merritt

Hill

et al. 2019

J Parenter Enteral Nutr

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“…Despite essentially halving the caloric intake in the RPN group over two years, their nutritional status was comparable to the SPN group. Citrulline has been extensively validated as a powerful marker of small bowel absorptive capacity [12,42]. Surprisingly, the RPN group had lower citrulline levels at PN initiation, however their citrulline levels also increased markedly faster than in the SPN group (Table 2).…”

Section: Discussionmentioning

confidence: 98%

“…Data presented as mean ± standard deviation. SBS-QoL, Short Bowel Syndrome-Quality of Life.The SF-36 Physical Component Summary (PCS) showed a significant improvement in quality of life from baseline to 6 months (29(24)(25)(26)(27)(28)(29)(30)(31)(32)(33) vs. 39(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42)(43)(44)(45)(46); 0.002), stayed constant between the 6 and 12 month time points(39 (31-46) vs. 36(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42)(43)(44)(45)(46); p = 0.069) and slightly improved between 12 and 24 months (36(30)(31)(32)(33)(34)(35)...…”

mentioning

confidence: 99%

Assessing Non-Invasive Liver Function in Patients with Intestinal Failure Receiving Total Parenteral Nutrition—Results from the Prospective PNLiver Trial

et al. 2020

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Liver abnormalities in intestinal failure (IF) patients receiving parenteral nutrition (PN) can progress undetected by standard laboratory tests to intestinal failure associated liver disease (IFALD). The aim of this longitudinal study is to evaluate the ability of non-invasive liver function tests to assess liver function following the initiation of PN. Twenty adult patients with IF were prospectively included at PN initiation and received scheduled follow-up assessments after 6, 12, and 24 months between 2014 and 2019. Each visit included liver assessment (LiMAx [Liver Maximum Capacity] test, ICG [indocyanine green] test, FibroScan), laboratory tests (standard laboratory test, NAFLD [non-alcoholic fatty liver disease] score, FIB–4 [fibrosis-4] score), nutritional status (bioelectrical impedance analysis, indirect calorimetry), and quality of life assessment. The patients were categorized post-hoc based on their continuous need for PN into a reduced parenteral nutrition (RPN) group and a stable parenteral nutrition (SPN) group. While the SPN group (n = 9) had significantly shorter small bowel length and poorer nutritional status at baseline compared to the RPN group (n = 11), no difference in liver function was observed between the distinct groups. Over time, liver function determined by LiMAx did continuously decrease from baseline to 24 months in the SPN group but remained stable in the RPN group. This decrease in liver function assessed with LiMAx in the SPN group preceded deterioration of all other investigated liver function tests during the study period. Our results suggest that the liver function over time is primarily determined by the degree of intestinal failure. Furthermore, the LiMAx test appeared more sensitive in detecting early changes in liver function in comparison to other liver function tests.

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Teduglutide in amyloidosis‐associated intestinal failure

Luhn,

Agis,

Hütterer

et al. 2023

Clinical Case Reports

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Key Clinical MessageAmyloidosis is a heterogeneous disease characterized by tissue deposition of abnormally folded fibrillary proteins that can manifest itself by a wide variety of symptoms depending on the affected organs. GI involvement among amyloidosis patients is common. Its clinical manifestation often presents with nonspecific symptoms such as weight loss, diarrhea, and malabsorption. With no specific treatment existing for GI amyloidosis, therapy focuses on impeding amyloid deposition and managing the patients' symptoms with supportive measures. Here, we present an AL‐amyloidosis patient with GI involvement and intestinal failure (IF) who was successfully treated with the glucagon‐like peptide‐2 (GLP‐2) analogue teduglutide. Over the course of treatment with teduglutide, the patient was able to achieve independence from parenteral nutrition and experienced a significant improvement in quality of life (QoL) as stool frequency and consistency improved, urinary output was stabilized and body weight as well as body composition improved over the course of teduglutide therapy. With no longer being exposed to the burden and associated risks of parenteral nutrition, we were able to reduce the potential morbidity and mortality rate as well as to improve the patient's overall QoL. Intestinal tissue biopsy workup revealed a histopathological correlate for the clinical response; Congo‐Red‐positive intestinal depositions almost completely disappeared within 6 months of teduglutide therapy. Implementing intestinotrophic GLP‐2 analogue teduglutide may enrich the spectrum of treatment options for amyloidosis patients with IF who are dependent on parenteral support.

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Determinants of Quality of Life in Patients With Intestinal Failure Receiving Long‐Term Parenteral Nutrition Using the SF‐36 Questionnaire: A German Single‐Center Prospective Observational Study

Cited by 33 publications

References 42 publications

Safety and Efficacy of Teduglutide in Pediatric Patients With Intestinal Failure due to Short Bowel Syndrome: A 24‐Week, Phase III Study

Safety and Efficacy of Teduglutide in Pediatric Patients With Intestinal Failure due to Short Bowel Syndrome: A 24‐Week, Phase III Study

Assessing Non-Invasive Liver Function in Patients with Intestinal Failure Receiving Total Parenteral Nutrition—Results from the Prospective PNLiver Trial

Teduglutide in amyloidosis‐associated intestinal failure

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