乌鸦传媒

LISBON -- A novel temporary duodenal-jejunal sleeve for weight loss improved weight and glycemic control in type 2 diabetes patients with refractory obesity, initial clinical use in a U.K. practice suggested.

Among the first 31 patients treated at a National Health Service facility with experience using the Endobarrier device through an earlier randomized trial, significant 1-year results were:

• Weight dropped by a mean 15.6 kg
• Mean BMI fell 5.7 points
• Hemoglobin A1c declined 2.3 percentage points
• Systolic blood pressure dropped 12.4 mm Hg
• Insulin use fell 70 units per day

Of 17 patients with 6 months of follow-up after removal of the Endobarrier, 11 sustained those improvements (65%), Robert Ryder, MD, of City Hospital, Birmingham, England, reported here at the European Association for the Study of Diabetes meeting.

Endobarrier -- available commercially in a number of European countries, Chile, and Australia, but not the U.S. -- is a 60-cm clear plastic sleeve placed endoscopically. From its anchor in the duodenum, the sleeve extends into the small intestine to move food particles from the stomach into the small intestine without contacting the jejunum, which is believed to be at the root of the metabolic effects seen with bypass surgery.

Of the 65 adults accepted for treatment by the small NHS Endobarrier service Ryder's group started in October 2014 for people with poorly controlled type 2 diabetes and obesity, 50 have had an Endobarrier implanted. The 31 who have passed the 1-year mark, at which point the device is supposed to be removed, were included in the analysis.

Not all 31 patients sustained benefits after that point. Ryder pointed out that four of six whose weight, glucose control, or both deteriorated after removal of the device had depression.

Two of the 31 (6.5%) had to have early removal of the device: One didn't adhere to recommended use of a proton pump inhibitor therapy and had gastrointestinal hemorrhage at 10 weeks. Another developed a liver abscess at 7 months, forcing device removal. Both resolved after removal.

Prior studies with Endobarrier have pointed to adverse effects, commonly pain, as well as some risk of obstruction and dislodgement, which were not discussed in Ryder's presentation.

Liver abscess tripped up the U.S. pivotal trial, leading it to be halted in 2015 after a rate of about 3.5% emerged. The company still plans another try at a trial to support FDA approval, Ryder said. For the U.K., Ryder noted that a secure online registry has been established for tracking these patients that may satisfy the National Institute for Health and Care Excellence there.

The results were intermediate compared with what's been seen with permanent procedures, such as Roux-en-Y bypass surgery, Ryder told 乌鸦传媒 at a press conference. "A lot of patients like the idea of something which is transient and reversible. I think it's approaching the idea that we now particularly foster, which is in the year with the Endobarrier in place, patients learn to change their ways, change their approach to food, break habits that they've developed over a lifetime and have not been able to break before."

No psychological screening or specific program of counseling was included, although Ryder said that there was "serious talk" with patients before the procedure about their issues with food that would have to be fixed.

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