Treating short bowel syndrome with pharmacotherapy

Rocha, Maria Cristina Pauli da; Lee, André Dong Won; Marin, Marcia Lucia de Mario; Faintuch, Salomão; Mishaly, Asher; Faintuch, Joel

doi:10.1080/14656566.2020.1724959

Cited by 8 publications

(3 citation statements)

References 60 publications

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“…Although PS is life sustaining, it is associated with potentially fatal complications including sepsis (mainly catheter-related bloodstream infections) [ 6 ], central vein thrombosis, intestinal failure associated liver disease [ 7 ] and decreased renal function [ 8 , 9 ]. Therefore, a major advancement in the treatment of SBS in recent years has been the introduction of glucagon-like peptide-2 (GLP-2) analog therapy to reduce or wean the patient off PS by enhancing the absorptive capacity of the remnant bowel [ 10 , 11 ].…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetics, Safety, and Tolerability of Glepaglutide, a Long-Acting GLP-2 Analog, in Subjects with Renal Impairment

et al. 2023

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Background Glepaglutide is a novel, ready-to-use, long-acting, glucagon-like peptide-2 (GLP-2) analog intended for the treatment of patients with short bowel syndrome (SBS). This study investigated the impact of renal function on the pharmacokinetics and safety of glepaglutide. Methods In this 3-site, non-randomized, open-label study, 16 subjects were enrolled: 4 with severe renal impairment (eGFR 15 to < 30 mL/min/1.73 m 2 ), 4 with end stage renal disease (ESRD) not on dialysis (eGFR < 15 mL/min/1.73 m 2 ), and 8 matching controls with normal renal function (eGFR ≥ 90 mL/min/1.73 m 2 ). Blood samples were collected over a 14-day period following a single subcutaneous (SC) dose of glepaglutide 10 mg. Safety and tolerability were assessed throughout the study. The primary pharmacokinetic parameters were area under the curve between dosing and 168 h (AUC 0-168 h ) and the maximum plasma concentration (C max ). Results There was no clinically relevant difference between subjects with severe renal impairment/ESRD and normal renal function with respect to total exposure (AUC 0-168 h ) and peak plasma concentrations (C max ) of glepaglutide following a single SC dose. A single SC dose of glepaglutide 10 mg appeared safe and well tolerated in subjects with normal renal function and subjects with severe renal impairment or ESRD. No serious adverse events were reported, and no safety issues were identified. Conclusions No difference in glepaglutide pharmacokinetics was seen between renal impaired and normal subjects. Based on this trial, dose adjustment appears not to be warranted in SBS patients with renal impairment. Trial Registration The trial is registered at http:// www. clini caltr ials. gov (NCT04178447) and has the EudraCT number: 2019-001466-15.

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Section: Introductionmentioning

confidence: 99%

Pharmacokinetics, Safety, and Tolerability of Glepaglutide, a Long-Acting GLP-2 Analog, in Subjects with Renal Impairment

et al. 2023

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“…1,2,32 For patients who only partially respond to teduglutide treatment, lifelong supplementation with IVS, enteral nutrition, and oral nutrition is anticipated. 65…”

Section: Stage Checklist Of Clinical Assessments and Monitoringmentioning

confidence: 99%

“…The clinical effects of teduglutide diminish upon treatment cessation, and patients may experience dehydration, FE imbalance, and micronutrient deficiency if not adequately monitored 1,2,32 . For patients who only partially respond to teduglutide treatment, lifelong supplementation with IVS, enteral nutrition, and oral nutrition is anticipated 65 …”

Section: Initiation and Ongoing Monitoring Of Patients Treated With T...mentioning

confidence: 99%

Use of teduglutide in adults with short bowel syndrome–associated intestinal failure

et al. 2023

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Short bowel syndrome (SBS) is a rare gastrointestinal disorder associated with intestinal failure (SBS‐IF) and poor health‐related outcomes. Patients with SBS‐IF are unable to absorb sufficient nutrients or fluids to maintain significantly metabolic homeostasis via oral or enteral intake alone and require long‐term intravenous supplementation (IVS), consisting of partial or total parenteral nutrition, fluids, electrolytes, or a combination of these. The goal of medical and surgical treatment for patients with SBS‐IF is to maximize intestinal remnant absorptive capacity so that the need for IVS support may eventually be reduced or eliminated. Daily subcutaneous administration of the glucagon‐like peptide 2 analog, teduglutide, has been shown to be clinically effective in reducing IVS dependence and potentially improving the health‐related quality of life of patients with SBS‐IF. The management of patients with SBS‐IF is complex and requires close monitoring. This narrative review discusses the use of teduglutide for patients with SBS‐IF in clinical practice. The screening of patient eligibility for teduglutide treatment, initiation, monitoring of efficacy and safety of treatment, adapting or weaning off IVS, and the healthcare setting needed for SBS‐IF management are described, taking into consideration data from clinical trials, observational studies, and clinical experience.

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Disease-modifying therapies in short bowel syndrome

Dreuille

Joly

2022

Current Opinion in Pharmacology

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Treating short bowel syndrome with pharmacotherapy

Cited by 8 publications

References 60 publications

Pharmacokinetics, Safety, and Tolerability of Glepaglutide, a Long-Acting GLP-2 Analog, in Subjects with Renal Impairment

Pharmacokinetics, Safety, and Tolerability of Glepaglutide, a Long-Acting GLP-2 Analog, in Subjects with Renal Impairment

Use of teduglutide in adults with short bowel syndrome–associated intestinal failure

Disease-modifying therapies in short bowel syndrome

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