Comparison of the Efficacy and Safety of the FDA-approved Intragastric Balloon Systems in a Clinical Setting.
Journal
Journal of clinical gastroenterology
ISSN: 1539-2031
Titre abrégé: J Clin Gastroenterol
Pays: United States
ID NLM: 7910017
Informations de publication
Date de publication:
01 07 2023
01 07 2023
Historique:
received:
11
10
2021
accepted:
30
03
2022
medline:
16
6
2023
pubmed:
24
5
2022
entrez:
23
5
2022
Statut:
epublish
Résumé
The gas-filled intragastric balloon (IGB) system (Obalon) and the fluid-filled IGB system (Orbera) are the current FDA-approved IGB systems to treat obesity; however, they have not been previously compared in clinical practice. The aims of this study were to compare their efficacy, tolerance, and safety in a clinical setting. This is a retrospective cohort study of consecutive patients treated with the gas-filled IGB or fluid-filled IGB between October 2015 and May 2020 at 2 academic centers. The primary endpoints included percent total body weight loss at balloon removal in patients who completed at least 20 weeks of therapy, the difference in adverse events that required urgent evaluation or hospitalization, and early removal in the 2 groups. A total of 87 patients underwent successful IGB placement (gas-filled IGB n=57, age 48.9±8.8, body mass index 35.5±5 kg/m 2 ; fluid-filled IGB n=30, age 49.2±14.3, body mass index 38.8±6 kg/m 2 ). Eleven patients underwent early device removal. There were no differences in percent total body weight loss at balloon removal and 12 months between the balloon systems ( P =0.39). Patients who received the fluid-filled IGB were more likely to require urgent evaluation or treatment, require hospital stay >24 hours, and need early balloon system removal compared with patients treated with the gas-filled IGB. In this 2-center cohort, both FDA-approved gastric balloon systems had the same effectiveness, but the gas-filled IGB had fewer serious adverse events and better tolerability than the fluid-filled IGB.
Sections du résumé
BACKGROUND AND AIMS
The gas-filled intragastric balloon (IGB) system (Obalon) and the fluid-filled IGB system (Orbera) are the current FDA-approved IGB systems to treat obesity; however, they have not been previously compared in clinical practice. The aims of this study were to compare their efficacy, tolerance, and safety in a clinical setting.
MATERIALS AND METHODS
This is a retrospective cohort study of consecutive patients treated with the gas-filled IGB or fluid-filled IGB between October 2015 and May 2020 at 2 academic centers. The primary endpoints included percent total body weight loss at balloon removal in patients who completed at least 20 weeks of therapy, the difference in adverse events that required urgent evaluation or hospitalization, and early removal in the 2 groups.
RESULTS
A total of 87 patients underwent successful IGB placement (gas-filled IGB n=57, age 48.9±8.8, body mass index 35.5±5 kg/m 2 ; fluid-filled IGB n=30, age 49.2±14.3, body mass index 38.8±6 kg/m 2 ). Eleven patients underwent early device removal. There were no differences in percent total body weight loss at balloon removal and 12 months between the balloon systems ( P =0.39). Patients who received the fluid-filled IGB were more likely to require urgent evaluation or treatment, require hospital stay >24 hours, and need early balloon system removal compared with patients treated with the gas-filled IGB.
CONCLUSION
In this 2-center cohort, both FDA-approved gastric balloon systems had the same effectiveness, but the gas-filled IGB had fewer serious adverse events and better tolerability than the fluid-filled IGB.
Identifiants
pubmed: 35604348
doi: 10.1097/MCG.0000000000001718
pii: 00004836-202307000-00007
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
578-585Informations de copyright
Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved.
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