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Endobarrier (R)

Report by Jacqueline Vogt, PharmD Candidate, UF College of Pharmacy

More than one-third of adults and approximately 17% of children and adolescents in the U.S. are obese, according to the Centers for Disease Control and Prevention and the National Health and Nutrition Examination Survey1.

Significantly more type 2 diabetes patients (42% vs. 12%, respectively) are able to achieve glycated hemoglobin (A1c) goals with bariatric surgery and medical therapy compared to medical therapy alone in 12 months2. A possible alternative to bariatric surgery, a device called Endobarrier®, is currently in clinical trials.

EndoBarrier® is a non-surgical intervention, a duodenal-jejunal bypass liner, which is endoscopically placed and left in for 6 to 12 months, with similar weight loss results to bariatric surgery as shown in small studies. EndoBarrier® is removable at any time. Reviews indicate promising results with skepticism on safety, especially in comparison to other implants such as an intragastric balloon4,5. According to Dennis Kim, M.D., M.B.A., in a recent interview:

“[Endobarrier®] is an extremely interesting intervention and a novel approach in potentially treating diabetes which allows us to understand how, who and why gastric bypass works, and especially in patients with type 2 Diabetes, dramatically improving their diabetes status and allowing a vast majority of patients to go into remission and discontinue their medications as their blood sugar homeostasis normalizes.”

Data presented at the Second World Congress on Interventional Therapies for Type 2 Diabetes in 2011 showed 83% of patients achieved an A1c less than 7% at 52 weeks and an average weight loss of greater than 20% at 12 months6. In another study by Eduardo Moura, MD, patients saw statistically significant reductions in fasting blood glucose (-30.3 ± 10.2 mg/dL), fasting insulin (-7.3 ± 2.6 µI/mL) and A1c (-2.1 ± 0.3%)7.

Endobarrier® replicates one component of gastric bypass surgery, according to Dr. Kim: “It appears that bypassing the [duodenal-jejunal] portion of the intestine has a profound metabolic effect on energy homeostasis, particularly with regards to glucose.” This metabolic effect on glucose homeostasis is at least partially due to an increase in glucagon-like peptide-1 (GLP-1) and peptide YY (PYY), which occur with Endobarrier® as well as gastric bypass surgery. GLP-1 and PYY are gastrointestinal hormones that help regulate various steps of glucose homeostasis. Both are pharmaceutical targets. GLP-1 agonists currently available include liraglutide and exenatide. PYY is a peptide and is therefore difficult to manufacture, as well as a myriad of other problems, so development has been unsuccessful.

Endobarrier® is neither malabsorptive nor restrictive. “[Endobarrier®] bridges the gap between pharmaceutical strengths and surgical therapy and individual data appears to show Endobarrier® is more effective than conventional therapies, and safer and better tolerated than gastric bypass or gastric banding,” according to Dr. Kim.

Most common adverse effects include nausea, vomiting and upper abdominal pain. Migration is possible and device should be removed if this occurs. Other complications include perforation, bleeding, aspiration and infection. Endobarrier® should not be used in patients requiring prescription anticoagulant, NSAID or ASA regimens. Endobarrier® should also not be used in patients with a history of inflammatory bowel disease or conditions of the GI tract, pancreatitis, uncontrolled GERD or H. pylori positive status8. Patients are recommended to begin a daily over-the-counter proton pump inhibitor, multivitamin and iron supplement throughout studies. Patients are also instructed to follow a liquid diet during the first 2 weeks following implantation and gradually transition to a normal diet7.

Results show statistically significant benefits not only on A1c but also waist circumference, systolic blood pressure, total cholesterol, LDL, triglycerides and fasting glucose9. Studies are also underway for re-implantation safety and efficacy, according to GI Dynamics10.

Endobarrier® will be an additional option for patients who can benefit from significant weight loss, especially those with type 2 diabetes mellitus, if approved in the U.S. According to Dr. Kim, Endobarrier® may be especially useful for patients who are not good candidates for bariatric surgery, like those with complications of obesity like sleep apnea or those with lower BMI. “[Endobarrier®] has a similar level of efficacy [to gastric banding] but the safety and tolerability profile look better [with Endobarrier®]”, according to Dr. Kim.

Endobarrier® is currently available in the UK, Netherlands, Austria, Germany, Australia and Chile. Larger, randomized control trials are needed before approval in the U.S., and clinical trials are ongoing.

Dr. Dennis Kim is a board certified endocrinologist with research focus on diabetes and obesity, and Clinical Assistant Professor of Medicine at University of California, San Diego. He is also Chief Medical Officer of Zafgen Inc. and President and a founding member of MetaCon, Inc.

References:
  1. CL Ogden, et al. Prevalence of Obesity in the United States, 2009-2010. Hyattsville, MD: National Center for Health Statistics. 2012 Jan;82:1-8.
  2. PR Schauer, et al. Bariatric Surgery versus Intensive Medical Therapy in Obese Patients. N Engl J Med. 2012 Mar 26. [Epub ahead of print]
  3. A Escalona, et al. Initial human experience with restrictive duodenal-jejunal bypass liner for treatment of morbid obesity. Surg Obes Relat Dis. 2010 Mar 4;6(2):126-31.
  4. EM Mathus-Vilegan. Endobarrier: a unique but still premature concept. Ned Tijdschr Geneeskd. 2012;156(13):A4590.
  5. Michel Gagner. Intragastric balloons appear safer and better than the endoscopic duodenojejunal bypass liners (DJBL) for preoperative weight loss in bariatric surgery. Gastrointestinal Endoscopy. 2011;73(4):850-1.
  6. EGH Moura, et al. Temporary duodenal-jejunal exclusion endoscopic device for weight loss and control of type 2 diabetes. Gastrointestinal Endoscopy Unit, University of São Paulo, University of São Paulo – Brazil, Endoscopic Unit Hospital das Clínicas. Poster presentation, 2nd World Congress on Interventional Therapies for Type 2 Diabetes (NY, NY) March 28-30, 2011.
  7. EGH Moura, et al. Metabolic Improvements in Obese Type 2 Diabetes Subjects Implanted for 1 Year with an Endoscopically Deployed Duodenal-Jejunal Bypass Liner. Diabetes Technology and Therapeutics. 2012;14(2):1-7.
  8. The Endobarrier Gastrointestinal Liner with Delivery System: Instructions for use. Lexington, MA: GI Dynamics. Retrieved from: http://www.endobarrier.com/safety.
  9. “One Year Study of a Weight Loss and Metabolic Syndrome Improvement Resulting from use of the Endoscopic Dudodenal-Jejunal Bypass Liner” IFSO 2010 Abstract. P Becenal, M Gabrielli, D Turiel, D Awruch, F Pimentell, A sharp, L lbanez, M Galvao, C Bambs, A Escalona. Retrieved from: http://www.gidynamics.com/media/publications-abstracts/04%20IFSO%202010%20abstract.pdf.
  10. GI Dynamics Press Release – April 27, 2012. GI Dyanmics Announces New Data Demonstrating Feasibility of EndoBarrier® Reimplantation. Data Presented for the First Time at the 5th Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders, European Chapter. Retrieved from: http://www.gidynamics.com/media-press-release.php?id=53. 

Copyright © 2012 Diabetes In Control, Inc.