DUBLIN — A swallowable gastric balloon (Allurion Balloon, formerly known as Elipse) combined with daily subcutaneous injections of the glucagon-like peptide 1 (GLP-1) agonist liraglutide (Saxenda, Novo Nordisk), leads to a significant average total body weight loss of 19% (18 kg or 40 lb) after around 4 months in people with obesity.
“The combination therapy [balloon and liraglutide] resulted in an additional weight loss compared to the two single treatments,” said Roberta Ienca, MD, from the Clinica Nuova Villa Claudia, Rome, Italy, who presented the findings at this year’s European Congress on Obesity (ECO).
“Despite both the balloon and liraglutide working on the early satiety feeling, the introduction of liraglutide around 1 month after [swallowing the balloon] or more frequently after 3-4 months, could sustain these feelings for a longer period of time,” she told Medscape Medical News.
“The addition of the GLP-1 agonist therapy (liraglutide) to patients treated with the Allurion program [gastric balloon] is feasible, safe, and effective in those who need additional weight loss,” she emphasized.
The balloon stayed inside participants’ stomachs for an average of 16 weeks and liraglutide was continued for an average of 4 months, resulting in a mean reduction in body mass index (BMI) of 6.4 kg/m2.
The Allurion is the world’s first and only swallowable gastric balloon placed without surgery, endoscopy, or anesthesia, and is excreted naturally after around 16 weeks.
The Allurion program delivered “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 cases of suboptimal adherence with the program,” Ienca said. “These two treatment approaches appear to have complementary mechanisms of action in a geographically and demographically diverse population.”
Adelardo Caballero, MD, director of the Institute of Obesity, Madrid, Spain, said that he had over 6 years of experience with the Allurion balloon in around 2500 cases. “Over the last 3 years, we have been using Allurion balloons in combination with GLP-1 agonists. In Europe, use of the swallowable gastric balloon is common, the results are good, and it is a safe tool.”
“Using liraglutide daily in subcutaneous form is authorized in Europe and is useful in overweight and mild obesity, while use in the combination [with the balloon] is also very popular,” he explained. “In the future, the combined use of semaglutide once-weekly GLP-1 agonist or the use of dual GLP-1/gastric inhibitory polypeptide agonists [such as tirzepatide]…with the swallowable intragastric balloon Allurion program or endoscopic sleeve gastroplasty will improve results,” he added.
Average 40-lb Weight Loss With Balloon and Liraglutide
For the current study, data from three international multidisciplinary obesity centers (in Italy, Spain, and Egypt) were retrospectively analyzed. All 181 patients received the combination of the Allurion balloon with liraglutide, with the latter added 4 to 16 weeks after swallowing the balloon.
During a 20-minute outpatient visit, participants swallowed the balloon, which was filled with liquid after reaching the stomach, and placement was confirmed by X-ray. The balloon remained inserted for around 15-17 weeks (mean 16 weeks) before natural excretion. All patients received liraglutide once daily for 1 to 6 months (mean 4 months). After excreting the balloon, patients started the Mediterranean diet for weight maintenance and were followed for at least 6 months.
Patients were monitored for weight loss, percentage total body weight loss, percentage excess weight loss, and BMI reduction. The timing of combining drug therapy with the Allurion program, metabolic results, and adverse event data were collected. However, Ienca explained that “the study was preliminary and aimed to evaluate feasibility and results of a combined treatment, so we didn’t collect long-term data.”
Liraglutide was mostly added in cases of unsatisfactory weight loss to boost weight reduction in patients with high BMIs, to sustain weight maintenance, and to aid diabetes control in patients with satisfactory weight loss. There were no criteria for time of onset of drug therapy in terms of a timepoint or percentage weight loss.
Before treatment, mean weight was 94.8 ± 21 kg and mean BMI was 33.7 ± 6.2 kg/m2. After 4 months of balloon treatment, weight loss, percentage total body weight loss, percentage excess weight loss, and decrease in BMI were 13.1 ± 7 kg, 13.9% ± 7.7%, 74.3% ± 57.1%, and 4.5 ±1.4 kg/m2 respectively.
After a mean duration of 4 months of liraglutide treatment (in addition to the gastric balloon), participants lost on average 18.1 ± 12.1 kg overall and 18.7% ± 12% of their initial total body weight. They shed 99.4% ± 84.9% of excess weight and reduced BMI by 6.4 ± 5.9 kg/m2.
Ienca explained that the study did not explore the separate contributions of the balloon or drug therapy to weight loss. “However, existing literature shows that the Allurion program leads to a weight loss of approximately 14% of total body weight after 4 months, while liraglutide studies report 12% of total body weight loss at 1 year,” he noted.
When describing the mechanism of action, Ienca said the Allurion balloon induces satiety and delays gastric emptying but the feeling of satiety starts to decrease after the first month. “For a few patients, this feeling of satiety decreases more rapidly or they have more difficulty putting in place new alimentary habits. In these patients, the addition of liraglutide gives an additional boost to support this behavioral change.”
Liraglutide-related adverse events included nausea (16.5%), diarrhea (3.3%), constipation (2.2%), and headache (1.7%), as well as drug discontinuation due to tachycardia/chest pain (1.1%) and gastrointestinal symptoms (1.1%).
Balloon removal due to intolerance occurred in 1.1% of patients, gastric dilation in 0.5%, and early balloon deflation in 0.5%. Other expected balloon-related adverse events included nausea, vomiting, and abdominal cramps.
The researchers note that the Allurion program offers a more acceptable option to balloon placement by endoscopy.
“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.”
European Congress on Obesity (ECO). Abstract AD01.01. Presented May 17, 2023.
Ienca has reported being a scientific consultant for Allurion. Caballero has reported no relevant financial relationships.
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