STOCKHOLM, Sweden — The benefits of duodenal jejunal bypass liner (EndoBarrier, GI Dynamics) may outweigh the risks for some patients with type 2 diabetes, new data show.
The EndoBarrier, a 60cm implantable cuff, is endoscopically placed in the first part of the small intestine, creating a physical barrier between the intestinal wall receptors and food. The mechanism mimics that of the Roux-en-Y bariatric gastric bypass procedure. It is placed for 12 months and then removed. It has been shown to cause weight loss and improve A1c levels in people with type 2 diabetes and obesity.
The device was never approved in the United States. It had received a CE mark in 2010 for the treatment of type 2 diabetes and obesity, but this was revoked in 2017 after the US Food and Drug Administration halted a pivotal US trial due to a 3.5% liver abscess rate. At the time, more than 3,000 patients had received the implant.
Today, GI Dynamics has requested restoration of the CE mark and initiated a new pivotal clinical trial in the United States.
Registry data for over 1000 patients in multiple countries implanted with EndoBarrier when available showed a much lower liver abscess rate of just 1.1%.
The real-world data was presented on September 20 here at the European Association for the Study of Diabetes (EASD) Annual Meeting 2022 by Bob Ryder, MD, Clinical Lead for Audits of the Association of British Clinical Diabetologists (ABCD) on New Antidiabetic Therapies and Devices.
The likely benefits of EndoBarrier outweigh the risks
“International data from the EndoBarrier Global Registry suggests that the likely benefits of EndoBarrier treatment outweigh the risks,” said Ryder, who conducted two clinical trials of the EndoBarrier at the UK’s National Health Service that are expected to be published soon.
He said Medscape Medical News that the device is not a first-line treatment for type 2 diabetes or obesity, but may be an alternative to bariatric surgery when lifestyle and drug therapy are not effective.
“You wouldn’t use it until you tried everything else. [Compared with bariatric surgery], it’s easy. Just slide the EndoBarrier in, [patients] lose a lot of weight and their diabetes improves.”
Asked for comment, session moderator Leszek Czupryniak, MD, PhD, said Medscape Medical News: “It’s an interesting device that has been around for quite some time. It was a large group with very impressive results. The most interesting thing is that you have [the EndoBarrier] implanted for a year and then it changes your life so much. You lose weight, it probably changes your lifestyle, and then you’re able to maintain that lost weight for years.”
Regarding the target patient population, Czupryniak said, “I would say that patients in whom drug therapy has failed or who cannot afford to pay [glucagon-like peptide-1 agonists] long term. Also, patients who will not agree to be operated on.”
“For those who have a [body mass index (BMI)] 50 kg/m2 or older who can no longer move around easily, there is very little to offer whether they have diabetes or not. It’s something between drug therapy and surgery, or maybe it could be combined with drug therapy. And it’s reversible, so if they don’t like it, you can take it out,” added Czupryniak, who is head of the department of diabetes and internal medicine at the University of Warsaw, Poland.
Improved A1c, weight, cholesterol and blood pressure
The independent and secure online registry was established under the auspices of ABCD in 2017 for the collection of EndoBarrier data worldwide after its withdrawal from several markets where it had been approved. As of March 2022, data had been submitted for 1022 patients from 34 centers in 10 countries, including Australia, Austria, Brazil, Czech Republic, England, Germany, Israel, Netherlands, Scotland and Slovenia.
Patients had a mean age of 51.3 years, 52.5% were male, mean BMI was 41.1 kg/m2and 84.9% had type 2 diabetes.
The device is inserted endoscopically during a 40-minute outpatient procedure and is intended to remain in place for only one year. It facilitates weight loss by preventing food absorption along a section of the duodenum and jejunum and is cheaper than bariatric surgery, at around $3,000, compared to $10,000 for a procedure such as bypass surgery gastric.
From baseline to the time of EndoBarrier explantation, patients lost an average of 13.3 kg (29 lbs), going from an average weight of 120 kg to 106.9 kg. A1c decreased by 13.7 mmol/mol (from 67.6 to 53.9 mmol/mol) or 1.3 percentage points (from 8.3% to 7.1%), systolic blood pressure 6.3 mmHg (135.6 to 129.5 mmHg) and cholesterol 0.6 mmol/L (4.8 to 4.2 mmol/L) (all P < .001).
Reductions in A1c varied widely by baseline, ranging from a drop of 17.0 mmol/L for those with baseline levels ≥ 53 mmol/L (7%) to a drop of 34.9 mmol/mol for people with baseline levels ≥ 86 mmol/mol (10%) (all P < .001).
Ryder also presented individual case reports of patients who, in addition to experiencing significant weight loss and reductions in A1c, also experienced improvements in fatty liver disease, obstructive sleep apnea, and function. renal.
“This‘is not a dangerous device”
Serious adverse events occurred in 43 patients, or 4.2% of the overall cohort. These included early ablation due to gastrointestinal bleeding in 2.3% (24 patients), liver abscesses in 1.1% (11 patients, eight of whom required early ablation and three found at time of routine explantation), early ablation due to pancreatitis or cholecystitis in 0.4% (4 patients), and liver abscess after prolonged implantation for more than 1 year in 0.2% (2 patients).
One patient had an early withdrawal due to sheath obstruction and another had an abdominal abscess due to EndoBarrier-related small bowel perforation.
Less serious adverse events occurred in 13.6% of patients (139 patients). These included early removal due to gastrointestinal symptoms or liner migration or obstruction in 7.3% (75 patients) and preventive hospitalization for gastrointestinal symptoms, difficult removal or endoscopy in 6.3% (64 patients).
“All of the patients with a serious adverse event made a full recovery, and most benefited significantly from treatment despite the adverse event,” Ryder said.
Czupryniak commented, “It’s a bold move to put something like this in the body. It also shows how desperate obese people are to lose weight.”
However, Czupryniak also noted, “The 1.0% is still low. If you’re doing a mechanically invasive procedure, it would be weird if nothing happened in a thousand patients. The rate is a bit higher than complications in bariatric surgery. You would expect 1% to 2% perioperative complications. It’s not a dangerous device. Just beware that something could happen.
Does it work long term?
In response to a question from the audience about long-term results after explantation, Ryder acknowledged that about 25% of participants regained weight over time.
But, he said, most didn’t, suggesting the patients were motivated by the device-induced weight loss. “I think the EndoBarrier has facilitated tremendous weight loss. [Patients] felt so good that it happened to them…that they basically broke the vicious cycle that kept them in that state, and many of them were able to simply maintain the improvement because they didn’t want to go back because they hated where they were.”
Czupryniak commented, “It’s really interesting. When you stop weight loss drugs, about 90% of people gain weight back. Only bariatric surgery offers a similar or even better level of maintenance. The 25% here are quite high in general, but we would expect that if you stop all weight loss interventions, almost everyone will gain weight back. Here it’s only 25%.”
Ryder said he has received speaker fees, consulting fees, and/or educational sponsorships from Abbott, BioQuest, GI Dynamics, and Novo Nordisk. Czupryniak said he received consulting and/or speaking fees from Sanofi, Boehringer Ingelheim, MSD, Lilly, Novo Nordisk, AstraZeneca, Roche and Abbott.
EASD 2022. Presented September 20, 2022. Summary OP 09.
Miriam E. Tucker is a freelance journalist based in the Washington, DC area. She is a regular contributor to Medscape, with other work appearing in The Washington Post, NPR’s Shots blog, and Diabetes Forecast magazine. She’s on Twitter: @MiriamETucker.
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