A new treatment for overweight and obesity combining the world's first and only procedureless swallowable gastric balloon—that is placed without surgery, endoscopy or anaesthesia and passes out of the body naturally after approximately 16 weeks—and the commonly prescribed anti-obesity drug liraglutide, is a safe and effective way to boost weight loss.
The international multi-centre study being presented at this year's European Congress on Obesity (ECO) in Dublin, Ireland (17-20 May), by Dr Roberta Ienca at the Nuova Villa Claudia Clinic, Rome, Italy and colleagues, builds on previous studies which show that the Allurion Balloon (known as Elipse), that is folded into a swallowable vegan capsule, is a simple, safe, and effective method for weight loss.
Glucagon like peptide-1 receptor agonists (GLP-1 RAs) like liraglutide (Saxenda) have also been shown to be effective in treating obesity and type 2 diabetes by enhancing feelings of fullness (satiety) and suppressing appetite.
In this study, researchers evaluated the efficacy and safety of the Allurion Balloon in combination with the commonly prescribed weight-loss drug liraglutide. A total of 181 patients (145 women and 36 men) were enrolled—their average age was 44 years old, average weight before treatment was 94.8Kg, and average initial body mass index (BMI) was 33.7kg/ m2.
The patients were treated at three international multidisciplinary obesity centres in Italy, Spain and Egypt.
The balloon is swallowed and filled with liquid after it reaches the stomach. Placement is performed in a 20-minute outpatient visit. The balloon usually stays in the patient for 15-17 weeks, with an average of 16 weeks. It is then excreted naturally.
Between week 4 and 16 after balloon placement, liraglutide was added once daily to enhance weight loss and maximise the results to increase patient satisfaction. All 181 patients received liraglutide. Patients' reasons for adding liraglutide were: unsatisfactory weight loss (53%), reduction of balloon induced satiety (29%), to further boost successful weight loss (16%) and diabetes control in those with satisfactory weight loss (2%).
After 16 weeks of balloon treatment, participants lost an average 13kg and 14% of their initial body weight (well above the 5-10% considered clinically meaningful weight loss). In addition, on average they shed 74% of excess weight (calculated using a reference normal BMI of 25 kg/m2) and reduced their BMI by 4.5kg/m2. As patients began their liraglutide treatment before the balloon was excreted, these first results include the early effects of liraglutide in most cases.
Once the balloon passed out of the body, patients were transitioned to a Mediterranean diet for weight maintenance and followed for at least 6 months.
At the end of the treatment with liraglutide (the average duration was four months for liraglutide treatment), participants lost on average 18kg and 19% of their initial body weight. In addition, on average they shed 99% of their excess weight and reduced their BMI by 5.9kg/m2.
No serious adverse events were recorded. Other balloon related adverse events including nausea, vomiting and abdominal cramps were managed with medication. In addition, four participants had the balloon removed due to intolerance, gastric dilation, or early balloon deflation.
Liraglutide related adverse events included nausea (16.5%), diarrhoea (3.3%), constipation (2.2%) and headache (1.7%). Overall, four participants discontinued drug therapy because of tachycardia/chest pain or gastrointestinal symptoms.
The authors explain that, although more effective than drugs, diet, and exercise, intragastric balloon uptake has been limited due to the need for endoscopy for placement.
"These two treatment approaches appear to have complementary mechanisms of action in a geographically and demographically diverse population," says Dr Ienca. "The Allurion Program delivers excellent weight loss in individuals with overweight and obesity without going under the knife, and liraglutide has the potential to further safely enhance weight loss in case of suboptimal adherence with the programme and for patients that are aiming to further boost the results of treatment."
She adds, "The ease of use, low rate of adverse events, and potentially lower cost of the Allurion Program could enable much wider application of this critical intervention and, ultimately, help the millions who struggle with obesity and its associated health complications."
