10 research outputs found

    Quality of Life in Teduglutide-Treated Patients with Short Bowel Syndrome Intestinal Failure—A Nested Matched Pair Real-World Study

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    Background: Quality of life (QoL) data of chronic intestinal failure (cIF) patients treated with the GLP-2 analogue teduglutide are scarce. This study aims to analyze QoL changes over time in teduglutide-treated patients and compare the results to a matched non-treated cIF control group in a real-world setting. Methods: QoL data (SF-36 and SBS-QoL(TM)) were obtained from adult cIF patients being treated with teduglutide and compared to previously collected QoL data from a PNLiver trial (DRKS00010993), during which patients had been therapy naive. The dataset was then extended by a pairwise matched control group (non-teduglutide-treated PNLiver trial patients) and follow-up data from this group were collected accordingly. Results: Median teduglutide treatment duration and the follow-up period of controls were both 4.3 years. SBS-QoL(TM) subscales and the SBS-QoL(TM) sum score showed significant improvements over time in teduglutide-treated patients, as well as for the SF-36 physical and mental component summary scores (all p < 0.02), while non-treated patients showed no significant changes in any of the mentioned scores. Significant differences of QoL changes between treated and non-treated patients were seen for both SF-36 summary scores (p = 0.031 and 0.012). Conclusions: We herein demonstrate for the first time that QoL significantly improved during teduglutide treatment in SBS-cIF patients in a real-world setting compared to individually matched non-treated SBS-cIF patients, indicating relevant clinical benefits

    Assessing Non-Invasive Liver Function in Patients With Intestinal Failure Receiving Total Parenteral Nutrition-Results From the Prospective PNLiver Trial

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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

    Application of non-invasive liver function tests in patients with chronic intestinal failure and parenteral nutrition

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    EINLEITUNG Die Hepatopathie (Intestinal failure associated liver disease, IFALD) bei Patienten mit chronischem Darmversagen und der konsekutiven Notwendigkeit einer langzeit-parenteralen Ernährung ist mit signifikanten Auswirkungen auf Morbidität, Mortalität und Lebensqualität behaftet. Klinische Arbeiten konnten bereits zeigen, dass frühzeitige Diagnosestellung und Therapie den Progress von IFALD verhindern können. Primäres Ziel dieser Studie war es daher den Einsatz nicht-invasiver Leberfunktionstests zu evaluieren sowie protektive und adverse Einflussfaktoren auf die Leberfunktion zu bestimmen. Sekundäres Ziel war es, die Lebensqualität der Patienten umfassend zu analysieren und Einflussfaktoren auf die Lebensqualität zu definieren. METHODIK Zwischen 2014 und 2017 wurden an der Charité – Universitätsmedizin Berlin 90 Patienten mit chronischem Darmversagen und parenteraler Ernährung in eine prospektive Studie eingeschlossen. Alle Patienten erhielten ein klinisches Labor, Leberassessment (LiMAx, ICG), Ernährungsassessment (BIA, indirekte Kalorimetrie) und Lebensqualitätsassessment (SBS-QoL, SF-36). Prädiktoren der Leberfunktion und Lebensqualität wurden mittels uni- und multivariater Analyse bestimmt. ERGEBNISSE LiMAx-, ICG-Test und FibroScan zeigten eine signifikante Korrelation mit laborchemischen Leberwerten. Die multivariable Analyse identifizierte ein reseziertes Ileum (p=0,010), Kurzdarmtyp I nach Messing (p=0,025), erniedrigtes Serum Citrullin (p=0,040), erhöhte parenterale Olivenölgabe (p=0,043) und fehlende orale Nahrungsaufnahme (p=0,040) als Risikofaktoren für eine reduzierte Leberfunktion im LiMAx-Test, wohingegen mittels ICG-Test und FibroScan keine signifikante Korrelation mit laborchemischen, gastrointestinalen und ernährungsassoziierten Parametern nachgewiesen werden konnte. Die multivariate Lebensqualitätsanalyse konnte mittels SF-36 und SBS-QoL Serum Citrullin und die orale Nahrungsaufnahme (SF-36 und SBS-QoL) sowie das Vorhandensein eines Stomas (SF-36) als unabhängige Einflussfaktoren auf die Lebensqualität identifizieren. Der krankheitsspezifische SBS-QoL zeigte zudem eine hoch signifikante Korrelation zu allen Kategorien des krankheitsunspezifischen SF-36. SCHLUSSFOLGERUNG In dieser Arbeit wurde erstmals der Einsatz dynamischer Leberfunktionstests bei Patienten mit chronischem Darmversagen und parenteraler Ernährung evaluiert. Der LiMAx-Test zeigte eine signifikante Korrelation mit etablierten Risikofaktoren für IFALD in der multivariaten Analyse, wohingegen der Nachweis mittels ICG-Test und FibroScan nicht gelungen ist. Unsere Ergebnisse legen nahe, dass der LiMAx-Test das Potenzial hat Risikopatienten für IFALD frühzeitig zu identifizieren und somit das Langzeitergebnis zu verbessern. Wir konnten zudem in einer umfassenden Lebensqualitätsanalyse zeigen, dass SF-36 und SBS-QoL gleichermaßen valide Messinstrumente zur Erfassung der Lebensqualität sind.INTRODUCTION Liver disease (Intestinal failure associated liver disease, IFALD) in patients with intestinal failure and the inevitable need of long-term parenteral nutrition significantly impacts morbidity, mortality and quality of life. Clinical studies have shown that early diagnosis and therapy are key to prevent the progression of IFALD. The primary aim of this study was to evaluate the capability of non-invasive liver function tests as well as to determine protective and adverse predictors of liver function. Secondary aim was to comprehensively analyse quality of life of these patients and to identify determinants of quality of life. METHODS Between 2014 and 2017, 90 patients with intestinal failure receiving parenteral nutrition were enrolled in a prospective study at Charité University Medicine Berlin. All patients underwent a conventional blood test, liver assessment (LiMAx, ICG), nutritional status assessment (BIA, indirect calorimetry) and quality of life assessment (SBS-QoL, SF-36). Predictors of liver function and quality of life were assessed by uni- and multivariate analysis. RESULTS LiMAx, ICG test, and FibroScan have shown a significant correlation with standard liver function tests. Multivariable analysis revealed resected ileum (p = 0.010), digestive anatomy type I according to messing (p = 0.025), decreased citrulline level (p = 0.040), increased parenteral olive oil intake (p = 0.043), and missing oral intake (p = 0.040) as risk factors for reduced liver function determined by LiMAx test, whereas ICG test and FibroScan failed to show significant correlations with laboratory, gastrointestinal and nutrition-related parameters. The multivariate analysis of quality of life measured by SF-36 and SBS-QoL has identified serum citrulline and oral intake (SF-36 and SBS-QoL) as well as the presence of a stoma (SF-36) as independent risk factors for reduced quality of life. The disease-specific SBS-QoL has shown a highly significant correlation with all categories of the non-disease-specific SF-36. CONCLUSION This is the first report evaluating dynamic liver function tests in patients with intestinal failure on parenteral nutrition. The LiMAx test has shown a significant correlation with widely accepted risk factors for IFALD in multivariate analysis, whereas ICG test and FibroScan failed to show significant correlations. Therefore, LiMAx test may have the potential to detect patients at risk for the development of IFALD and thereby improve long-term outcome. Furthermore, we have demonstrated that both SF-36 and SBS-QoL are equally valid instruments for quality of life assessment in patients with intestinal failure

    Quality of Life in Teduglutide-Treated Patients with Short Bowel Syndrome Intestinal Failure—A Nested Matched Pair Real-World Study

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    Background: Quality of life (QoL) data of chronic intestinal failure (cIF) patients treated with the GLP-2 analogue teduglutide are scarce. This study aims to analyze QoL changes over time in teduglutide-treated patients and compare the results to a matched non-treated cIF control group in a real-world setting. Methods: QoL data (SF-36 and SBS-QoLTM) were obtained from adult cIF patients being treated with teduglutide and compared to previously collected QoL data from a PNLiver trial (DRKS00010993), during which patients had been therapy naive. The dataset was then extended by a pairwise matched control group (non-teduglutide-treated PNLiver trial patients) and follow-up data from this group were collected accordingly. Results: Median teduglutide treatment duration and the follow-up period of controls were both 4.3 years. SBS-QoLTM subscales and the SBS-QoLTM sum score showed significant improvements over time in teduglutide-treated patients, as well as for the SF-36 physical and mental component summary scores (all p p = 0.031 and 0.012). Conclusions: We herein demonstrate for the first time that QoL significantly improved during teduglutide treatment in SBS-cIF patients in a real-world setting compared to individually matched non-treated SBS-cIF patients, indicating relevant clinical benefits
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