Obese patients who underwent placement of an intragastric balloon and participated in a behavioral management program lost significantly more weight than patients in a behavioral management program alone, researchers reported here.
The Orbera Intragastic Balloon System met thresholds of an endoscopic bariatric therapy as a primary obesity intervention set by the American Society for Gastrointestinal Endoscopy (ASGE), said Barham Abu Dayyeh, MD, a bariatric endoscopist at the Mayo Clinic in Rochester, Minn., and colleagues at the Digestive Disease Week annual meeting.
Patients who underwent the treatment saw improvements in diabetes, hypertension, lipid levels, depression, and quality of life.
“I think this is very exciting data,” said John Vargo II, MD, MPH, chair of the department of gastroenterology and hepatology at the Cleveland Clinic in Ohio, at a press conference. Obesity is “a tsunami of an epidemic” in the U.S., he added.
The year-long, multicenter, randomized, prospective trial included 273 patients, ages 18 to 65, with a body mass index (BMI) of 30-40 kg/m2.
Exclusion criteria were previous gastrointestinal surgery or obstruction, a hiatal hernia >3 cm, a motility disorder, inflammatory bowel disease, and a positive Helicobacter pyloriscreening test.
After a run-in period with the device implanted in 35 patients, the 273 subjects were randomized to undergoing balloon implantation and behavioral management and undergoing behavioral management alone.
The balloon was filled with 500-600 cc of saline and formed a “bezoar” so that patients felt a feeling of satiety. It was removed after 6 months.
Patients in both the control and intervention groups received behavioral management treatment for 12 months.
Primary endpoints were based on recommendations set out by the ASGE for primary obesity intervention in patients with a BMI of greater than 35 kg/m2:
- Subjects should achieve a mean minimum threshold of 25% excess weight loss (EWL) at 12 months.
- The mean percent EWL difference between intervention and control groups should be at least 15% and statistically significant.
Three months after removal of the balloon (9 months into the study), patients in the intervention group had a mean EWL of 26.5% (95% CI 22.9-30.1%). They maintained an EWL of greater than 25% at 1 year.
Also at 3 months’ post-balloon removal, more than 30% of patients in the intervention group differed by at least 15% EWL from the control group. The 15% EWL difference was maintained at the year-mark (P<0.001 at 9 months and 12 months).
At 1 year, intervention participants had a mean percent total body weight loss of 7.7% compared with 3.9% of those in the control group (P<0.001).
The intervention group had lower rates of diabetes mellitus (0.98% versus 4.1%), hypertension (5.7% versus 15.2%), and dyslipidemia (3.4% versus 9.0%) at 1 year.
Device-related serious adverse events affected 9.6% of patients and included “intolerance,” gastric outlet obstruction, laryngospasm during placement, severe abdominal cramping, and severe dehydration. No deaths were reported.
Common adverse events included nausea and vomiting (32.8%), abdominal pain (12.6%), reflux (5.4%), eructation (4.8%), dyspepsia (4.4%), and constipation (4.4%).
A total of 22% (28) of patients removed the device early, though only 15 of those were for symptoms.
The authors concluded that “this represents a minimally-invasive and effective approach to manage obesity and associated comorbidities.”