The following is a summary of “Comparison of the Efficacy and Safety of the FDA-approved Intragastric Balloon Systems in a Clinical Setting,” published in the July 2023 issue of the Clinical Gastroenterology by Swei et al.
The gas-filled intragastric balloon (IGB) system (Obalon) and the fluid-filled IGB system (Orbera) are the current FDA-approved intragastric balloon (IGB) systems indicated for the treatment of obesity. However, a direct comparison between these two systems in clinical practice has yet to be conducted. The objectives of this study were to evaluate the effectiveness, tolerability, and safety of these interventions in a clinical setting. This retrospective cohort study of consecutive patients treated with the gas-filled intragastric balloon (IGB) or fluid-filled intragastric balloon (IGB) between October 2015 and May 2020 at 2 academic centers.
The primary endpoints encompassed the percentage of total body weight loss upon balloon removal in patients who underwent at least 20 weeks of therapy, the disparity in adverse events necessitating urgent evaluation or hospitalization, and the early removal rates within the two groups. A total of 87 patients underwent successful intragastric balloon (IGB) placement. Among them, 57 patients received a gas-filled IGB with an average age of 48.9±8.8 years and a body mass index of 35.5±5 kg/m2. The remaining 30 patients received a fluid-filled IGB with an average age of 49.2±14.3 years and a body mass index of 38.8±6 kg/m2. Eleven patients underwent premature device extraction. There were no significant variations in the percentage of total body weight loss observed during balloon removal and at the 12-month mark between the different balloon systems (P=0.39).
Patients who underwent the fluid-filled intragastric balloon (IGB) procedure exhibited a higher likelihood of necessitating urgent assessment or intervention, requiring a hospitalization period exceeding 24 hours, and requiring early removal of the balloon system compared to patients who received the gas-filled IGB treatment. In this cohort study conducted at two medical centers, it was observed that both gastric balloon systems approved by the Food and Drug Administration (FDA) exhibited similar effectiveness. However, the intragastric balloon (IGB) filled with gas demonstrated a lower incidence of serious adverse events and improved tolerability compared to the IGB filled with fluid.
Source: journals.lww.com/jcge/Abstract/2023/07000/Comparison_of_the_Efficacy_and_Safety_of_the.7.aspx
