Summary
Endoscopic placement of the EndoBarrier reduces weight by 14% and HBA1c by 1.5% after 24 weeks. While not reaching the magnitude of weight loss from bariatric surgery, these changes are impressive and substantially exceed those seen with pharmacologic monotherapy. If this efficacy is validated in future trials, and there are no safety issues, this approach could be useful for a large number of obese patients.
Analysis
GI Dynamics has developed a 'gastrointestinal liner' that is placed by endoscopy. Interim results from an open-label non-randomized trial show reductions of 14% in body weight and 1.5% in HBA1c in 19 obese (BMI=47) patients with type 2 diabetes mellitus (baseline HBA1c = 7.8%). Follow up was 24 weeks, and further patients are being enrolled. These results are consistent with earlier trials with this device - some of which were randomized.
The EndoBarrier is essentially a small intestine open ended 'condom' that prevents nutrient absorption in the proximal small intestine. In some ways, it has a similar mechanism to a Roux-en-Y procedure, in that nutrients are not absorbed by the proximal small intestine. Enhanced nutrient delivery to the distal small intestine will also increase GLP-1 levels (and this may explain the rapid enhanced glycemic control seen in early studies).
Given that many patients are reluctant to have bariatric surgery for cost and safety reasons, this device has substantial potential to help obese patients (with and without diabetes). It offers substantially greater efficacy than pharmacotherapy, and (hopefully) substantially greater safety than surgery. The company is also developing an endoscopic gastric outlet restriction device that doubles the weight loss achievable in preclinical models. Even without such an enhancement it would not be unrealistic to think that this procedure could be used by a majority of obese diabetic patients if efficacy and safety are maintained in larger scale trials. The fact that it is a device and not a drug should also help accelerate FDA approval.
The EndoBarrier is essentially a small intestine open ended 'condom' that prevents nutrient absorption in the proximal small intestine. In some ways, it has a similar mechanism to a Roux-en-Y procedure, in that nutrients are not absorbed by the proximal small intestine. Enhanced nutrient delivery to the distal small intestine will also increase GLP-1 levels (and this may explain the rapid enhanced glycemic control seen in early studies).
Given that many patients are reluctant to have bariatric surgery for cost and safety reasons, this device has substantial potential to help obese patients (with and without diabetes). It offers substantially greater efficacy than pharmacotherapy, and (hopefully) substantially greater safety than surgery. The company is also developing an endoscopic gastric outlet restriction device that doubles the weight loss achievable in preclinical models. Even without such an enhancement it would not be unrealistic to think that this procedure could be used by a majority of obese diabetic patients if efficacy and safety are maintained in larger scale trials. The fact that it is a device and not a drug should also help accelerate FDA approval.
Analyses are solely the work of the authors and have not been edited or endorsed by GLG.
