This article is more than 5 years old. Information may no longer be current.
Dual balloon implant improved weight loss for adults with obesity
Click Here to Manage Email Alerts
Patients with obesity lost more weight with a temporary intragastric dual balloon implant and medically supervised diet and exercise program compared with the diet and exercise program alone, according to research presented at Obesity Week 2014.
“This presents a new option for patients with BMI between 30 and 40 who are not ready, or not qualified, for surgery to continue to lose weight,” Jaime Ponce, MD, FACS, FASMBS, of the Hamilton Medical Center in Dalton, Ga., told Endocrine Today.
Jaime Ponce
“When you look at the spectrum of obesity, patients initially may try different diets and exercise, and sometimes go to physicians who provide programs, or try medications for weight loss,” Ponce said. “They sometimes exhaust all those, and the next step is really surgery, but not everyone is a candidate.”
In the prospective, sham blinded, two-arm, randomized controlled REDUCE Pivotal Trial involving 326 patients (mean age, 44 years; 95% female) with chronic obesity (mean BMI, 35.4 kg/m2), Ponce and colleagues from other institutions studied the safety and efficacy of the ReShape Duo integrated dual balloon system.
The investigators evaluated outcomes with the endoscopic balloon system treatment plus diet and exercise (DUO, n=187) and a sham endoscopy plus diet and exercise (DIET, n=187). Co-primary endpoints were percentage excess weight loss and DUO responder rate at 6 months, as set forth by the FDA, Ponce said. The DUO group then had the system removed and another 6 months of counseling, and the DIET group was then offered the balloon implant.
“There had to be a difference of more than 7.5% weight loss between the treatment group and the group without the balloon, but the difference was actually around 15%, or two times,” Ponce said. “More than 35% of patients with treatment also had to lose more than 25% of excess weight, but actually 54% of patients lost that amount, so we met that endpoint by far.”
At 6 months, the percentage excess weight loss with DUO was 25.1% (intent-to-treat, 27.9% completed cases, or n=167) vs. 11.3% with DIET (intent-to-treat, 12.3% completed cases, or n=126; P=.004). The response rate with DUO was 49.1% (intent-to-treat, P<.001, 54.5% completed cases) for weight loss dichotomized at 25% excess weight loss.
Balloon deflation occurred in 6% of patients without device migration, and retrieval due to intolerance occurred in 15% of patients. Three patients had serious adverse events, Ponce said, including pneumonia, contained cervical esophageal perforation and an ulcer that required hemostatic clips to stop the bleeding.
“The treatment does not really compete with surgery because it is temporary, but it offers an opportunity for patients to lose more weight than they have with diet and exercise,” Ponce said.
REDUCE trial data on the device, developed by Southern California-based ReShape Medical Inc., has been submitted to the FDA, Ponce said. The system has been available in Europe since 2011 but limited to experimental use in the United States, according to a press release.
Although no time frame has been announced, Ponce anticipates the FDA will have a panel established to review the trial, or will have finalized the review, in the first or second quarter of 2015.
“This study has met the two primary endpoints that were set up, so we do believe we have good chances for approval,” Ponce said, “but that’s up to the FDA after they review it.” – by Allegra Tiver
For more information:
Ponce J. Abstract A104. Presented at: Obesity Week; Nov 2-7, 2014; Boston.
Disclosure: Ponce reports honorarium and/or research support from Apollo Endosurgery, Gore, ReShape Medical and USGI Medical, and serving on the speakers’ bureau or as a consultant for all but USGI.
Perspective
Back to Top
Ranjan Sudan, MD
This is an important development not only for low BMI patients but also patients who may be otherwise high risk who need to lose weight, such as very high BMI and overweight patients who would normally be staged as those who undergo a sleeve and then either a RYGB or a duodenal switch. The balloon has the potential in such instances to reduce risks and costs of two operations to one. There are also other high risk groups such as those with cancers or end-stage organ disease but use in such patients would need further investigation.
Click Here to Manage Email Alerts