New weight loss pill
A new gastric balloon that can be swallowed like a pill and then filled while in the stomach, helped patients lose more than 37 percent of their excess weight over four months, according to new research presented here at Obesity Week 2015, the largest international event focused on the basic science, clinical application and prevention and treatment of obesity. The week long conference is hosted by the
American Society for Metabolic and Bariatric Surgery (ASMBS) and The Obesity Society (TOS).
Allurion Technologies, the manufacturer of the device called Elipse, whichis not yet commercially available, is studying what it says is the “first procedure less gastric balloon” inpatients with a body mass index (BMI) of 27 or more.
Thetreatment involves patients swallowing a capsule that quicklydissolves in the stomach to reveal a deflated gastric balloon inside.With a thin catheter attached to the device, but long enough toremain outside the patient’s mouth, a physician fills the balloonwith fluid (550 mL) to about the size of a grapefruit. The catheteris then removed, while the balloon remains in the stomach for fourmonths. At that point, a valve designed to open on its own, allowsthe balloon to empty and be excreted naturally from the body,eliminating the need for endoscopy or another procedure.
“Likeother gastric balloons, the mechanism of action of Elipse is likelymultifactorial and includes increased satiety from the reduction ofavailable space in the stomach, delayed gastric emptying, and changesin hormones that control hunger and appetite,” saidRam Chuttani, MD*, study co-author and director of Endoscopy andchief, Interventional Gastroenterology at Beth Israel DeaconessMedical Center in Boston. “Our findings demonstrate that Elipseprovides individuals and their caregivers with a safe, effective, andnon-invasive weight loss intervention that does not require surgery,endoscopy, or anesthesia.”
Researchers presented interim results for the first 34 patients of a multi-center study that showed individuals lost an average of 22 pounds after four months or 37 percent of their excess weight. Patients also sawimprovements in triglycerides and hemoglobin A1c (HgbA1c) levels,risk factors for heart disease and diabetes. Similar to othergastric balloons, the most common adverse events reported were nauseaand vomiting.
NinhT. Nguyen, MD, immediate past president of the ASMBS and vice-chair, UC Irvine Department of Surgery and chief of gastrointestinal surgery, who was not involved in the study said the device is not a permanent solution to weight loss, but has the potential to help those individuals who areover weight or have obesity and are not candidates for bariatric surgery.
“New treatment options are being studied and approved for the treatment of obesity, which is good news for our patients and the healthcare professionals involved in their treatment,” said Dr. Nguyen, whowas not involved in the study. “For many struggling with their weight, procedure less gastric balloon devices may serve as a treatment option that bridges the gap between weight-loss drugs andsurgery.”
TheU.S. Food and Drug Administration (FDA) this year alone approved theOrbera Intragastric Balloon from Apollo Endosurgery and theReShapeIntegrated Dual Balloon System from ReShape Medical. Bothdevices are indicated for adults with BMIs between 30 and 40 whocould not lose weight through diet and exercise alone.The FDA also approved threeweight-loss drugs since 2012.
Inaddition to Dr. Chuttani, study authors of the abstract entitled,“The First Procedureless Gastric Balloon: A Prospective StudyEvaluating Safety, Weight Loss, Metabolic Parameters and Quality ofLife,” include, Evzen Machytka MD, PhD,Martina Bojkova MD, TomasKupka MD, and Marek Buzga MSc, PhD from the University of Ostrava,Ioannis Raftopoulos MD, Andreas Giannakou MD, and Kandiliotis IoannisMD from the Iatriko Medical Center, and Kathy Stecco MD, Samuel LevyMD, and Shantanu Gaur MD, from Allurion Technologies.
About Obesity and Metabolic and Bariatric Surgery
According to the Centers of Disease Control and Prevention (CDC), more than 78 million adults were obese in 2011–2012.iThe ASMBS estimates about 24 million people have severe or morbid obesity. Individuals with a BMI greater than 30 have a 50 to 100 percent increased risk of premature death compared to healthy weight individuals as well as an increased risk of developing more than 40 obesity-related diseases and conditions including type 2 diabetes,heart disease and cancer.
Metabolic/bariatricsurgery has been shown to be the most effective and long lastingtreatment for morbid obesity and many related conditions and resultsin significant weight loss. The Agency for Healthcare Research andQuality (AHRQ) reported significant improvements in the safety ofmetabolic/bariatric surgery due in large part to improved laparoscopic techniques. The risk of death is about 0.1 percent and the overall likelihood of major complications is about 4 percent.