Speakers Discuss Wide Array of New FDA-Approved Treatments for Managing Obesity

At a session during Digestive Disease Week 2017, held May 6-9 in Chicago, Illinois, speakers highlighted some new approaches to managing obesity that are now approved by the FDA.

First, Aurora D. Pryor, MD, FACS, professor of surgery at Stony Brook Medical Center, took the stage to summarize the current options in balloon therapy, 2 of which are placed endoscopically while another comes in a swallowable capsule. The idea behind all of these balloons is that they will take up space in the stomach, causing patients to cut back on portion sizes.

The 3 balloons currently approved by the FDA (ReShape, Obalon, and Orbera) have largely been tested on patients with a body mass index (BMI) between 30 and 40 who have been obese for at least 2 years and have failed at more conservative weight loss methods, Pryor explained, and they might be wary of more invasive surgical procedures like the laparoscopic band.

Pryor cautioned that the balloons, while “easy and straightforward, aren’t completely symptom free.” She mentioned that the FDA had issued a warning that balloons could result in spontaneous over-inflation or acute pancreatitis, but emphasized that these reactions were rare. Pryor ended her talk by discussing how clinicians are undertreating obesity. “This is a major epidemic and we’re not doing justice to our patients,” she said. “Balloons are a relatively safe and very effective therapy, and offering these increases interest in surgery and may help treat more patients.”

The next speaker was John Morton, MD, MPH, FACS, FASMBS, chief of bariatric and minimally invasive surgery at Stanford School of Medicine. He discussed the need for nonsurgical devices and interventions for patients uncomfortable with the risk-benefit tradeoffs of bariatric surgery, and presented one potential alternative.

Morton has been a leading researcher in developing vBloc, a device that sends intermittent signals through inserted leads to block the vagal nerve, which could potentially send satiety signals to the thalamus. The first randomized trial of the device was the ReCharge trial published in JAMA in 2014, in which Morton and his co-authors demonstrated that this therapy was effective long-term and had larger and more durable effects than a placebo surgery.

He ended his presentation by showing the audience a “brand-new, hot off the presses” abstract that detailed results for vBloc in the real-world environment. In the trial, 90% of participants achieved meaningful weight loss, meaning they shed at least 5% of their original body weight. Although no treatment options for managing obesity are ever going to be perfect, Morton said, the results seen from safe and effective treatments like vBloc demonstrate that weight loss interventions other than surgery can be successful.

Christopher C. Thompson, MD, MSc, of Brigham and Women’s Hospital, presented research on aspiration therapy, which essentially drains food from the stomach after eating. He acknowledged that this treatment is “very controversial,” and demonstrated this point by playing a clip from Stephen Colbert’s Late Show in which the comedian referred to the therapy as “machine-assisted abdominal vomiting” aided by a “chest-mounted barf bot.”

Despite reactions like these to aspiration therapy, Thompson said he hoped to make the audience “more comfortable with its mechanism of action.” That mechanism, he explained, is a gastronomy tube left in the stomach that can be attached to an external device used by patients to drain part of their gastric contents 20 to 30 minutes after a meal. In a randomized controlled trial, the therapy resulted in significant excess weight loss, and the patients continued to lose weight after 1 year.

The researchers determined that the observed weight loss was higher than could be explained by just the calorie aspiration, which they attributed partially to changes in eating habits. In follow-up surveys, the study participants reported they chewed their food more, ate fewer snacks, and decreased their calorie consumption, according to Thompson. Still, 92% of patients said they were very or somewhat satisfied with the therapy.

He emphasized that careful selection of motivated patients is crucial. “This is a lifestyle adjustment, so if they can’t make that adjustment because their life’s just too chaotic, this is not for them,” he said.

Thompson concluded that “aspiration therapy provides substantial, durable, and safe weight reduction” while being less invasive than surgery, which “might be advantageous and also may be less expensive than other alternatives.”

Finally, Nitin Kumar, MD, of the Bariatric Endoscopy Institute, spoke to the audience about the importance of a multidisciplinary team approach in endoscopic bariatric therapy for obesity management. This team should include a dietician, a psychologist, a behavioral coach, a physical therapist, in addition to the endoscopy team and the primary care physician.

All of these providers “don’t necessarily need to be in your office or on your payroll” as long as they are available. Together, they will help coach the patient to successfully change their lifestyles and address specific barriers to weight loss. This is particularly important in the endoscopic therapy care model, where “the intensity of lifestyle therapy correlates with success,” Kumar said.

He also noted some important considerations for practices looking to provide bariatric weight loss interventions, like avoiding stigma by referring to a patient’s BMI in numbers rather than using words like “fat” or “heavy.” Every aspect of the office, from the exam tables to the gowns to the doorways, must be chosen with the patient’s comfort in mind.

“In conclusion, endoscopic bariatric therapy really requires comprehensive care for the patient with obesity,” Kumar said. “It’s important to prepare your practice staff and then continuously assess and improve their performance as it relates to patients with obesity. The bottom line is, the procedure’s not the end of care, it really is just part of it, and a long-term approach is essential.”