WASHINGTON — The insertion of an intragastric balloon produced more than 10% total body weight loss in patients included in a study, which was significantly more than behavior modification, a presenter said during Digestive Disease week.
“Our treatments for obesity in the United States are lacking,” Barham Abu Dayyeh, MD, MPH, from the Mayo Clinic in Rochester, Minn., said during his presentation. “This balloon fills this gap and could provide effective management for patients with obesity that are underserved because they do not qualify for bariatric surgery, but are not being managed effectively by lifestyle intervention or medication.”
Barham Abu Dayyeh
In what Abu Dayyeh described as a “simple endoscopic procedure,” a balloon is inserted into a patient’s stomach and filled with 500 to 600 cc of saline, “stimulating gastric mechanical receptors” and “aiding the patient in effective weight loss.”
In this study, Abu Dayyeh and colleagues looked at 125 patients who received the intragastric balloon (Orbera Intragastric Balloon System, Apollo Endosurgery) and 130 controls. These patients were between the ages of 18 and 65 years and had BMI between 30 and 40 kg/m2 with obesity for more than 2 years.
Total and excess body weight loss between groups, in a modified intention-to-treat analysis, showed significantly more weight loss in the treatment group than in the controls (P < .001).
"The percent excess weight loss at 12 months observed in the Intragastric balloon group was 29.3% compared to 14.1% in the control group," Abu Dayyeh told Healio Gastroenterology.
In looking at secondary outcomes, the treatment group showed greater reduction in diabetes (4.1% vs. 0.98%), hypertension (15.2% vs. 5.7%) and lipids (9% vs. 3.4%) vs. the control group. Additionally, the treatment group had improved Beck Depression Inventory scores compared with the controls (3.4 vs. 2.7, respectively). Quality of life improved in both groups, but was more improved in the treatment group.
In regard to safety, there were no deaths in the treatment group, though 12 patients reported device-related serious adverse events, as compared to nine in the control group. Incidence of common adverse events such as nausea, vomiting, abdominal pain and others, was greater than 2.5%, though the majority were mild to moderate.
When compared to the thresholds set by the American Society of Gastrointestinal Endoscopy for incorporation of novel endoscopic devices, Abu Dayyeh showed that in the patients who were examined at 12 months (treatment group, n = 98; control group, n = 93), the intragastric balloon exceeded requirements.
“Percent excess weight loss observed in the Intragastric balloon group at 12 months exceeded the 25% set forth in the PIVI company and was more than 15% in that seen in controls (P < .01),” Abu Dayyeh told Healio Gastroenterology,
“This intragastric balloon system produces significant weight loss that is preserved even after device removal with a favorable safety profile,” Abu Dayyeh said in his presentation. “It is a safe and effective adjunct to lifestyle intervention for weight loss in individuals with lower BMI between 30 to 40 kg/m2.” – by Katrina Altersitz
For more information:
Abu Dayyeh B, et al. Abstract 444. Presented at: Digestive Disease Week; May 16-19, 2015; Washington, D.C.
Disclosures: Dayyeh reports financial relationships with Apollo Endosurgery, Aspire Bariatrics and GI Dynamics.
Editor's note: This article has been updated on May 26 with clarification from the presenter.