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Obalon better than diet, exercise and lifestyle therapy alone

Average percent total weight loss after six months for Obalon balloon patients was 6.81 percent, while those in the sham control group had 3.59 percent total average weight loss

Patients with obesity treated with the Obalon gas-filled balloon capsules designed to help them eat less, lost 1.9 times more weight than patients who relied on diet, exercise and lifestyle therapy alone, according to research presented at ObesityWeek 2016. The study, “A 6-month Swallowable Balloon System Results in Sustainable Weight Loss at 1 Year: Results from a Prospective, Randomized Sham-Controlled Trial,” were presented by Dr Aurora Pryor, study co-author and Chief Bariatric, Foregut and Advanced GI Surgery, Stony Brook University.

Aurora Pryor

“The significant weight loss achieved with the Obalon 6-Month Balloon System is maintained at 12 months,” said Pryor. “This combination of lifestyle modification and balloon therapy provides a new low risk option for patients struggling with obesity.”

The Obalon 6-Month Balloon System, a swallowable, gas-filled intragastric balloon for weight loss in adults with obesity for whom diet and exercise has failed, was approved in September by the FDA, and involves a balloon contained within a capsule that, once it reaches the stomach, is inflated with gas via a microcatheter. Up to three balloons may be placed over the first three months, but the entire treatment period lasts six months. The inflated balloons make patients feel full. Treatment is accompanied by a moderate intensity diet and behaviour modification program.

Results of the study were based on a double-blinded randomised, sham-controlled trial of 387 patients, about half of whom received treatment with the Obalon balloon and the other half with a sugar-filled sham capsule designed to look like the device. Patients with BMI30-40, swallowed three capsules over a 12-week period (one every three weeks). All patients at the 15 study sites also underwent 25 minutes of lifestyle therapy administered by a blinded registered dietitian every three weeks. At Week 24, the blind was revealed and the Obalon balloons were removed endoscopically. After six months, patients were informed which capsule they received and those with the Obalon balloons had them removed endoscopically.

The co-primary endpoints were: 1) the difference in mean %TWL between the treatment group and sham group is greater than 2.1%, and 2) a Responder Rate, defined as >=5% TWL, achieved in >=35% of participants. In Phase 2 (unblinded) the treatment group was followed for six months after removal where subjects continued with 25 minutes of lifestyle therapy administered by a registered dietitian every three weeks. The sham group was offered optional 6-month balloon therapy. Treatment group weight loss maintenance after balloon removal was calculated as %TWL and percent excess weight loss (%EWL) at one year.

In total, 387 subjects swallowed at least one device, with 366 subjects included in the per protocol analysis.  One hundred and eighty five subjects received Obalon Balloon capsules (treatment group: age 42.8±9.5yrs, BMI 35.2±2.7) and 181 received sham capsules (sham group: age 42.7±9.4yrs, BMI 35.5±2.7). Least-square mean %TWL at six months was 6.9±5.0% and 3.6±5.0% in the treatment and sham groups for a difference of 3.3%TWL (p=0.026). Treatment group %EWL at six months was 25.2±19.2%. A total of 171 Treatment Group subjects lost weight with therapy and completed Phase I, participated in the six month follow up (Phase 2), which is now completed. Figure 1 shows all data points collected on the 171 Treatment patients that participated in the 6-month follow-up phase.

Figure 1: All data points collected on the 171 Treatment patients that participated in the 6-month follow-up phase

At 24 weeks and end of balloon therapy, mean %TWL was 7.6±4.4% and %EWL was 28.0±17.2%. All treatment group subjects have completed one year of therapy with %TWL of 6.8%±6.5% and %EWL of 24.7%±24.4%. No unanticipated device events and a single (0.3%) serious adverse device event occurred during the balloon period (gastric ulcer after protocol prohibited nonsteroidal anti-inflammatory drug use for outpatient knee replacement, managed conservatively). Non-serious adverse device events (mostly abdominal cramping and nausea) occurred in 90.8% of subjects; 99.6% were rated mild or moderate. A single adverse event, a bleeding gastric ulcer, occurred in one balloon patient on high dose NSAIDs who had an outpatient knee replacement procedure. Non-serious adverse device events, mostly abdominal cramping and nausea, occurred in 90.8 percent of patients (99.6% were rated mild or moderate).

“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,” said Dr Raul J Rosenthal, ASMBS President and Chairman, Department of General Surgery, Cleveland Clinic Florida, who was not involved in the study. “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.”

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