NEW ORLEANS — Patients who used the Obalon balloon system lost almost twice as much weight as patients who adopted diet, exercise and lifestyle changes, and they maintained their weight loss through 12 months, according to research presented at ObesityWeek.
The Obalon Balloon System (Obalon Therapeutics) involves three intragastric balloons that are folded within capsules that are swallowed and inflated with gas by a micro-catheter once they reach the stomach. They are placed sequentially over 3 months and are then endoscopically removed after 6 months, throughout which patients adhere to a diet and behavior modification program.
Preliminary data were presented at DDW 2016, and the FDA has since approved the product for adults with obesity for whom diet and exercise has failed.
New follow-up data shows “the significant weight loss achieved with the Obalon 6-Month Balloon System is maintained at 12 months,” Aurora D. Pryor, MD, chief of bariatric, foregut and advanced GI surgery at Stony Brook University, said in a press release. “This combination of lifestyle modification and balloon therapy provides a new low risk option for patients struggling with obesity.”
Pryor and colleagues performed a double blind, randomized, sham controlled trial comprising 387 adults with obesity at 15 sites in the U.S., 366 of whom swallowed at least two balloons and completed 18 weeks of therapy.
In the first phase of the trial, the researchers randomly assigned 185 individuals to receive the Obalon balloons and 181 to receive sham capsules, paired with 25 minutes of lifestyle therapy every 3 weeks. Participants were unmasked at week 24 and the balloons were then endoscopically removed.
As was previously presented, mean total weight loss at 6 months was 6.9% ± 5% in the Obalon group compared with 3.6% ± 5% in the sham group (3.3% difference; P = .026). Moreover, the treatment group had 25.2% ± 19.2% excess weight loss at 6 months.
In the second phase of the trial, 171 patients who lost weight with the Obalon balloon were then followed for 6 additional months after removal, during which time they continued with the lifestyle intervention. At the end of phase 1, mean total weight loss was 7.6% ± 4.4% and excess weight loss was 28% ± 17.2% in these patients; and at the end of phase 2, these figures were 6.8% ± 6.5% and 24.7% ± 24.4%, respectively.
Device-related adverse events included mostly abdominal cramping and nausea, which occurred in 90.8% of patients, were reported to be mild or moderate 99.6% of the time. No unexpected device-related events occurred, but one serious adverse device-related event — a gastric ulcer related to NSAID use — occurred during the treatment period.
“There is no magic pill for obesity, but this swallowable balloon and other intragastric balloons may offer new hope to people who otherwise would not seek treatment or not have as good a result with diet and exercise alone,” Raul J. Rosenthal, MD, president and chairman of the American Society for Metabolic and Bariatric Surgery, also from the department of general surgery at Cleveland Clinic, Florida, and uninvolved with the study, said in the press release. “The balloon and other technologies may help to fill the therapeutic gaps between diet and exercise and medical therapy, and medical therapy and surgery, where the gaps are quite large.” – by Adam Leitenberger
Pryor AD. A140. Presented at: ObesityWeek 2016; Oct. 31-Nov. 4, 2016; New Orleans.
Disclosures: Pryor reports financial relationships with Ethicon, Medtronic, Gore, Apollo, and Intuitive.