Swallowable intragastric balloon safe, effective in adults with obesity

In adults with obesity, a swallowable intragastric balloon combined with a very low-calorie ketogenic diet resulted in a mean weight loss of 15.2 kg without serious adverse events, according to findings presented at the European Congress on Obesity.

“The Elipse balloon (Allurion Technologies) appears to be a safe and effective weight-loss method,” Roberta Ienca, a researcher in experimental medicine at Sapienza University in Rome, and colleagues said in a press release. “Because the Elipse balloon does not require endoscopy, surgery or anesthesia, this may make it suitable for a larger population of obese patients not responding to diet/lifestyle treatments and also for use by a variety of clinicians — nutritionists, dietitians and internists — who currently do not have access to or are qualified to fit endoscopic or surgical weight loss devices.”

In a prospective, nonrandomized study, Ienca and colleagues analyzed data from 42 adults with BMI between 30 kg/m² and 45 kg/m² who failed to lose weight with diet alone and who had declined other intragastric balloon treatment (mean age, 46 years; 29 men; mean baseline weight, 109.7 kg; mean BMI, 38.6 kg/m²). Under fluoroscopy, patients swallowed the Elipse balloon, which was then filled with 550 mL of liquid. The balloon remained in the stomach for 16 weeks, according to the researchers, before spontaneously opening and emptying. Patients followed a low-calorie diet the first 12 weeks, followed by a very low-calorie ketogenic diet (700 kcal per day) in the last 4 weeks of therapy to enhance weight loss. Follow-up took place every 2 weeks. Once the balloon was excreted, researchers transitioned patients to a Mediterranean diet for weight maintenance.

At 16 weeks, mean weight loss was 15.2 kg; mean excess weight loss was 31%; mean BMI reduction was 4.9 kg/m². At weeks 4, 8 and 12, mean weight loss was 5.4 kg, 8.9 kg and 11.5 kg, respectively; mean weight loss during the very low-calorie ketogenic diet period was 3.7 kg.

No serious adverse events were reported. Other adverse events included nausea, vomiting and abdominal pain. The researchers also noted reductions in comorbidities, including diabetes, hypertension and metabolic syndrome.

The balloon is approved for commercial use in Europe and parts of the Middle East; the device has not been evaluated by the FDA. – by Regina Schaffer

Reference:

Ienca R, et al. Poster T3P5. European Congress on Obesity; May 17-20, 2017; Porto, Portugal.

Disclosure: Endocrine Today was unable to determine relevant financial disclosures.