WASHINGTON – Obese patients implanted with an intragastric balloon lost significantly more weight than those following a behavioral modification program in a randomized, nonblinded trial.
Moreover, weight loss was preserved even after device removal, study author Dr. Barham Abu Dayyeh said at the annual Digestive Disease Week.
Dr. Barham Abu Dayyeh
The Orbera intragastric balloon (Apollo Endosurgery) could fill a gap in the United States between obesity lifestyle interventions that are minimally effective and a range of bariatric surgical interventions that are effective, but come at a cost of increased complications and health care costs, he said. Moreover, only 1% of qualified patients actually end up having bariatric surgery.
The silicone, saline-filled intragastric balloon (IGB) has been widely used outside the U.S. for more than 17 years in more than 200,000 patients, added Dr. Abu Dayyeh* of Mayo Clinic in Rochester, Minn.
The multicenter trial was designed for premarketing approval in the U.S. of the Orbera IGB and randomly assigned 273 adults with a body mass index (BMI) of 30-40 kg/m2 for more than 2 years to a 12-month behavioral modification program with or without endoscopic placement of the IGB filled to 500-600 cc. The balloon was removed at month 6, with regular office visits through 1 year.
Eighteen patients withdrew before treatment; 215 patients were evaluable at 6 months, 206 at 9 months, and 191 at 12 months. The mean baseline BMI was 35 kg/m2 and 90% of patients were female.
At 6 months, the mean percent total body weight loss was greater in the IGB group than the control group (about 10% vs. 4%; P < .001), Dr. Abu Dayyeh said, noting that total body weight loss was significantly higher in the balloon group at each time point: 3, 6, 9, and 12 months.
Similarly, the mean percent of excess weight loss at 6 months was better in the balloon group than in the control group (about 40% vs. 13%; P < .001). The majority of excess weight loss achieved at 6 months was also maintained at 12 months, he said.
At 9 months (3 months after device removal), 45.6% of patients in the IGB group had an excess weight loss at least 15% higher than patients in the control group, which exceeded the 30% threshold set as a primary study outcome, he said.
The mean percent excess weight loss was 26.5% at 9 months in the balloon group, which also exceeded the 25% threshold set as a second primary outcome.
This IGB system “appears to meet the thresholds set forth by the ASGE/ASMBS PIVI for endoscopic bariatric therapies intended as a primary obesity intervention,” Dr. Abu Dayyeh said.
The American Society for Gastrointestinal Endoscopy/American Society for Metabolic and Bariatric Surgery PIVI (Preservation and Incorporation of Valuable endoscopic Innovations) recommends that endoscopic bariatric therapies intended as a primary obesity intervention achieve a mean minimum threshold of 25% excess weight loss at 12 months.
At 52 weeks, both groups had an improvement from baseline in diabetes, hypertension, and lipids, but the improvement was greater with the IGB, he said.
Beck Depression Scores and quality of life also improved in both groups, with the improvement again greater with the IGB.
Serious adverse events were reported by 7% of controls and 9.6% of the balloon group including 8 early removals for intolerance, 1 gastric outlet obstruction, 1 laryngospasm during placement, 1 case of severe abdominal cramping, and 1 case of severe dehydration.
Early device removals occurred in 22% of patients, 15 for symptoms and 13 at subject request, Dr. Abu Dayyeh said. No deaths occurred in the trial.
*Changed on July 8, 2015.
On Twitter @pwendl