WASHINGTON, DC — An intragastric balloon system is an effective and safe addition to lifestyle interventions for promoting weight loss in obese patients, new research has demonstrated.
And weight loss is preserved even after the device is removed, said Barham Abu Dayyeh, MD, from the Mayo Clinic in Rochester, Minnesota.
"The intragastric balloon is an intermediate option between lifestyle change and bariatric surgery," he explained. It is more effective than lifestyle interventions, but less expensive than bariatric surgery.
"It could provide effective management for the obese population that is currently underserved," he said, adding that only 1% of eligible obese patients actually undergo surgery.
Dr Abu Dayyeh presented the study results here at Digestive Disease Week 2015.
Placement of the intragastric balloon is an endoscopic outpatient procedure. Once it is in the stomach, the balloon is filled with a saline solution, up to 500 cc, and then deployed. The balloon induces feelings of satiety, aiding in effective weight loss, he explained.
In their 15-center study, Dr Abu Dayyeh and his team evaluated the safety and efficacy of the intragastric balloon in adults who had a body mass index (BMI) from 30 to 40 kg/m² for at least 2 years.
The device they used — the Orbera intragastric balloon system from Apollo Endosurgery — has been used outside the United States for more than 17 years in more than 200,000 patients, Dr Abu Dayyeh reported.
The team randomly assigned 125 patients to balloon therapy plus a 12-month behavioral management program; 113 patients assigned to behavioral management alone served as the control group. The patients were followed for 52 weeks, which was 26 weeks after explantation of the balloon.
The study population was about 90% female, mean age was approximately 40 years, mean BMI was 35 kg/m², and mean excess weight was 36 kg. The groups were well matched at baseline.
At 3, 6, 9, and 12 months, weight loss was significantly better in the balloon group than in the control group.
Weight Loss
At 6 months, when explantation took place, the mean percent total weight loss was greater in the balloon group than in the control group (approximately 10% vs 4%; P < .001). This weight loss was maintained at 12 months, which was 6 months after balloon retrieval.
Also at 6 months, the percent of excess weight lost was better in the balloon group than in the control group (40% vs 13%; P < .001). Again, the majority of this weight loss was maintained at 12 months.
At 9 months — 3 months after explantation — 45.6% of patients in the balloon group had an excess weight loss at least 15% higher than patients in the control group. This surpassed the 30.0% threshold set by the researchers as the primary study outcome.
In addition, the mean percent excess weight loss at 9 months was 26.5% in the balloon group, which surpassed the 25.0% threshold set by the researchers.
There was a reduction in the severity of comorbid conditions, such as diabetes, hypertension, and dyslipidemia, from baseline in both groups, but the magnitude of the reduction was greater in the balloon group.
There was also an improvement in quality of life, especially in the balloon group, Dr Abu Dayyeh reported. The improvement in Beck Depression Inventory scores in the balloon group was greatest at 52 weeks.
Serious Adverse Events
Serious adverse events were more common in the balloon group than in the control group (9.6% vs 7.0%). Nausea, vomiting, and abdominal pain were occasionally reported, but were manageable. No deaths occurred. Early explantation was requested by 22% of the patients.
Results from this study exceed the thresholds for primary obesity intervention — set by the American Society of Gastrointestinal Endoscopy and the American Society for Metabolic and Bariatric Surgery — of 25% excess weight loss at 12 months, and a difference between an intervention and control group of at least 15%. "We exceeded these," Dr Abu Dayyeh pointed out.
The intragastric balloon system is a "really important advance," especially if, in addition to weight loss, it can improve comorbid parameters such as glycemic control, said Jonathan Cohen, MD, from the New York University School of Medicine in New York City.
The target group had a mean BMI of 35 kg/m², which is in the "sweet spot" where more options are clearly needed, he explained. "This is one of the emerging options in a field that definitely needs more options," he told Medscape Medical News.
"It was exciting that the investigators showed that they met targets that the professional societies have set for how good a weight loss intervention must be before it's adopted," he said.
If and when intragastric balloons are approved by the US Food and Drug Administration, they should be used in conjunction with "a proper holistic bariatric approach, which involves lifestyle, nutrition, medicines, and sometimes bariatric surgery."
This study was funded by Apollo Endosurgery. Dr Abu Dayyeh reports financial relationships with Apollo Endosurgery, Aspire Bariatrics, and GI Dynamics.
Digestive Disease Week (DDW) 2015: Abstract 444. Presented May 17, 2015.
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Cite this: Gastric Balloon Fills Stomach, Leads to Weight Loss - Medscape - May 21, 2015.
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