Conference Interview #8 of 19
Liz Meszaros, MDLinx
San Diego, California, United States | May 21-24, 2016
“In general, all of us as practitioners, gastroenterologists, and physicians really need to recognize that obesity is a disease, and we should be treating it as a disease. We shouldn’t be demonizing our patients and blaming the disease and lack of treatment for this disease on our patients. We should be taking it upon ourselves to give them the therapies that will allow them to be successful with their weight loss,” said lead researcher, Shelby Sullivan, MD, director of bariatric endoscopy, Washington University School of Medicine, St. Louis, MO.
For this randomized, sham-controlled study conducted at 15 US centers, Dr. Sullivan and colleagues included subjects aged 22 to 64 years with a BMI that ranged from 30 to 40 kg/m2, randomizing them to treatment or control groups.
Subjects in the treatment group (n=185; mean age: 42.8±9.5 years; mean BMI: 35.1±2.7 kg/m2) were required to swallow three capsules containing the balloon, and those in the control group (n=181; mean age: 42.7±9.3 years; mean BMI: 35.3±2.7 kg/m2) swallowed a sugar-filled sham capsule. Subjects from both groups also completed time-limited, lifestyle therapy that was administered every 3 weeks by a registered dietitian who was blinded to group assignment.
To bring about better intra-gastric balloon tolerability and stimulate weight loss over the entire treatment period, subjects swallowed capsules in a progressive manner. Dr. Sullivan and fellow researchers included those patients who swallowed at least two capsules and completed 18 weeks of therapy in their pre-defined per protocol analysis.
At week 24, the balloons were endoscopically removed. Administration times averaged 9.5±4.1 minutes, and removal times, 16.9±8.5 minutes. In all, 387 subjects swallowed at least one balloon, and 366 were included in the per protocol assessment.
In the treatment group, the difference in percent total body weight loss (%TBWL) was 6.81%±5.1%, and in the control group, 3.59%±5.0%, for a difference of 3.23% TBWL (P=0.0338). Corresponding responder rates were 64.3% and 32.0%, respectively. Subjects in the treatment group exhibited significant improvements in systolic blood pressure, fasting glucose levels, LDL cholesterol, and triglycerides, but those in the control group did not.
In all, only one serious adverse device event occurred, which was a gastric ulcer after a patient used nonsteroidal anti-inflammatory drugs for conservatively managed outpatient knee replacement, which had been prohibited by the study protocol. Furthermore, 89.9% of patients experienced non-serious adverse device events, comprised primarily of abdominal cramping and nausea, and of these, 99.7% were rated to be only mild or moderate.
“The next step for this therapy is really to show what it does in a more clinical-practice-like setting. We’ve shown, in an efficacy study, that it has twice as much benefit as the sham does. The next most important study that needs to be done with this therapy is in that single-arm design, where everybody knows that they have a balloon in place, and we give them the kind of lifestyle therapy that they would get in clinical practice,” concluded Dr. Sullivan.