1. Quality of life in patients with short bowel syndrome treated with the new glucagon-like peptide-2 analogue teduglutide--analyses from a randomised, placebo-controlled study
- Author
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P. Berghöfer, Simon M. Gabe, Francisca Joly, N.N. Youssef, S. Loth, Palle Jeppesen, Alastair Forbes, Marek Pertkiewicz, Loris Pironi, H. Heinze, Bernard Messing, Jeppesen PB, Pertkiewicz M, Forbes A, Pironi L, Gabe SM, Joly F, Messing B, Loth S, Youssef NN, Heinze H, and Berghöfer P
- Subjects
Adult ,Quality of life ,medicine.medical_specialty ,Organ Dysfunction Scores ,Injections, Subcutaneous ,Drinking ,Drug Resistance ,Placebo-controlled study ,Critical Care and Intensive Care Medicine ,Placebo ,Teduglutide ,Gastroenterology ,chemistry.chemical_compound ,Glucagon-like peptide 2 analogue ,Cost of Illness ,Double-Blind Method ,Gastrointestinal Agents ,SHORT BOWEL SYNDROME ,Internal medicine ,Intestine, Small ,Glucagon-Like Peptide 2 ,Receptors, Glucagon ,Humans ,Medicine ,Adverse effect ,Aged ,Gastrointestinal agent ,Nutrition and Dietetics ,business.industry ,Organ Size ,Middle Aged ,Short bowel syndrome ,medicine.disease ,humanities ,Surgery ,Intestinal Diseases ,Parenteral nutrition ,chemistry ,Glucagon-Like Peptide-2 Receptor ,Parenteral Nutrition, Home ,Peptides ,business - Abstract
Summary Background & aims Short bowel syndrome (SBS)-intestinal failure (IF) patients have impaired quality of life (QoL) and suffer from the burden of malabsorption and parenteral support (PS). A phase III study demonstrated that treatment with teduglutide, a glucagon-like peptide 2 analogue, reduces PS volumes by 32% while maintaining oral fluid intake constant; placebo-treated patients had reduced PS by 21%, but oral fluid intake increased accordingly. As effects of teduglutide on QoL are unknown, they were investigated here. Methods QoL analyses from a double-blind, randomised Phase III study in 86 SBS-IF patients receiving teduglutide (0.05 mg/kg/day s.c.) or placebo over 24 weeks. At baseline and every 4 weeks, QoL was assessed using the validated SBS-QoL™ scale. Results PS reductions were associated with QoL improvements (ANCOVA, p = 0.0194, SBS-QoL per-protocol). Compared to baseline, teduglutide significantly improved the SBS-QoL™ total score and the score of 9 of 17 items at week 24. These changes were not significant compared to placebo. Teduglutide-treated patients with remaining small intestine >100 cm experienced more gastrointestinal adverse events (GI-AE), unfavourably affecting QoL. Conclusions Overall, PS volume reductions were associated with improvements in SBS-QoL™ scores. The short observation period, imbalances in oral fluid intake in relation to PS reductions, large patient and effect heterogeneity and occurrence of GI-AE in a subgroup of teduglutide-treated patients may account for the inability to show statistically significant effects of teduglutide on SBS-QoL™ scores compared to placebo. ClinicalTrials.gov identifier: NCT00798967.
- Published
- 2013