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Endoscopic liner benefits

Studies reinforce benefits of EndoBarrier

EndoBarrier causes rise in ghrelin, and decrease in leptin, leading to improved satiety
Device can safely be re-implanted after initial treatment is complete, improving clinical benefits
One study found that another EndoBarrier could be inserted a year after the first is removed, extending the treatment.

Results from a pair of studies into GI Dynamics’ EndoBarrier gastrointestinal liner were presented at the 20th United European Gastroenterology Week, describing the device’s influence on hormones affecting satiety and blood sugar control, and suggesting that it can be effectively re-implanted after its initial insertion period, extending its clinical benefits.

The results were announced as GI Dynamics work to get the EndoBarrier authorised for use in the USA. It is currently certified for use in Europe and Australia.

Hormones

The first results, presented on a poster entitled “The impact of the EndoBarrier on body weight and satiety hormones”, studied 17 obese patients with type 2 diabetes with the device implanted. After 24 weeks, the researchers found a rise in the levels of ghrelin, and a decrease in levels of leptin leading to increased satiety in 15 out of the 17 patients, and a reduced caloric intake in all patients.

During the 24-week study, patients lost an average of 12.7±1.3kg in body weight, and a 29.8%±3.5% reduction in excess weight.

Stuart A. Randle, president and CEO of GI Dynamics, said: “These data suggest that EndoBarrier Therapy mimics the way gastric bypass manipulates hormonal signals in the small intestine to lower blood sugar, induce appetite reduction and lower caloric intake. 

The data complement previously-reported results from the same study, which found a “rapid and sustained” increase in insulin sensitivity, increased levels of PYY and GLP-1 hormones one week post-placement, and a normalisation of the glucagon response, leading to a reduction in use of anti-diabetic medications in 16 out of 17 patients.

“EndoBarrier Therapy has the potential to redefine how we approach the treatment of type 2 diabetes and obesity,” said Randle.

Re-implantation

The second study, presented on a poster titled “One year follow-up after re-implantation of the endoscopic duodenal-jejunal bypass liner”, found that re-implanting an EndoBarrier imparted additional weight-loss benefits to the patient for up to three years.

While the EndoBarrier is currently indicated for implantation periods of up to 12 months, the study suggests that additional clinical benefits can be gained by re-implanting a device approximately one year after the completion of the initial treatment period.

For the study, 19 obese patients who had completed 12 months of EndoBarrier implantation and 31 weeks of post-implantation follow-up had the device installed again. 14 of the patients completed a second year with the device.

From baseline to the removal of the second device, patients lost an average of 22.6kg, resulting in a decrease in BMI from 43.8±5.9 to 33.5±5.2.

Their mean level of FPG dropped from 106.6±5.2, which the American Diabetes Association regards as a diagnosis of prediabetes, to 93.4±21.3, a reading regarded as within the normal range.

There were no procedure-related complications associated with the re-implantation of the device.

Randle said, “this re-implantation data expands our current understanding by demonstrating that the overall health benefits of initial EndoBarrier Therapy can be safely extended and improved following a second treatment period.”

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