A peer-reviewed, evidence-based journal that promotes clinical development and metabolic insights in total bariatric patient care for the healthcare professional
Issue link: https://bariatrictimes.epubxp.com/i/651228
15 Emerging Technologies Bariatric Times • March 2016 patients receiving the balloon. Patients were followed for 12 months and were assessed at 6, 9, and 12 months. Patients who r eceived the balloon demonstrated superior weight loss to the control arm at all time points through the pivotal study. At six months, weight loss in the balloon group was 10.2 p ercent of total body weight versus 3.3 percent in the lifestyle modification only group. Statistically significant differences in weight loss were seen between t he balloon and the control arm at nine months (9.1% vs. 3.4%) and 12 months (7.6% vs. 3.1%). The majority of the adverse events were mild to moderate with t he most common adverse events being nausea, vomiting, and reflux. The most common severe adverse event was early removal of the device due to intolerance. The incidence rate of nausea (86.9% of patients), vomiting (75.6%), and early removals (18.8%) were higher than the international experience due to the management protocols. No balloon deflations or ulcerations were reported in the US pivotal study. ReShape Integrated Dual Balloon System was approved by the FDA on July 28, 2015, based on the REDUCE pivotal trial. 8 This study was a prospective, sham-controlled, double-blind, randomized multicenter United States clinical study that enrolled 326 patients with obesity and followed them for 48 weeks. Participants were between 21 and 60 years of age with a baseline BMI between 30kg/m 2 and 40kg/m 2 . Participants also presented with one or more obesity-related comorbid conditions, including type 2 diabetes mellitus (T2DM), obstructive sleep apnea (OSA), and hypertension. Patients were randomized into two groups. The DUO group (n=187) underwent the ReShape Integrated Dual Balloon procedure plus diet and exercise counseling. The DIET group (n=139) underwent sham endoscopy plus diet and exercise alone. DUO patients had the device removed after 24 weeks and continued with diet and exercise counseling for an additional 24 weeks. After 24 weeks, the patients in the DUO group had significantly greater weight loss than the DIET group. DUO patients had a 28 percent EWL and 2.3 times as much weight loss compared to the DIET group. 8 Twenty-four weeks after balloon removal, DUO patients maintained a mean of 66 percent of their initial weight loss. More than half of the subjects still had more than 25 percent EWL compared to baseline w eight, and 25 percent of subjects continued to lose additional weight following device removal. 8 Clinically and statistically significant comorbid improvements were observed in diabetic, hypertensive, and hyperlipidemic o utcomes, and these improvements were sustained through 48 weeks of follow up. Quality of life assessments demonstrated substantial improvements in subjects' sense of well-being as measured by both obesity-specific a nd general instruments, and measures of patient satisfaction with the results of the procedure "The endoluminal therapies, like the intragastric balloon, helps to fill the gap between lifestyle/diet and p harmacoptherapy, and surgery, especially for the patient population with BMIs 30–40kg/m 2 . These therapies may a ttract patients to our practices and allow them to undergo effective treatment for their obesity."