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ABCD EndoBarrier Registry

GI Dynamics reveals worldwide EndoBarrier Registry Data at EASD

The registry has more than doubled in the number of patient records, including the addition of the complete data set from the German EndoBarrier Registry

GI Dynamics has announced positive data from the Association of British Clinical Diabetologists (ABCD) Worldwide EndoBarrier Registry evaluating the benefit: risk of EndoBarrier, presented by Dr Katharina Laubner of the University of Freiburg, Germany. The data was presented at the 55th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Barcelona, Spain.

The poster, ‘Duodenal-jejunal Bypass Liner (DJBL) for Treatment of Type 2 Diabetes and Obesity – The Risk: Benefit Ratio from the Worldwide EndoBarrier Registry in 871 Patients,’ demonstrated the safety and efficacy profile that EndoBarrier provides patients diagnosed with type 2 diabetes and/or obesity. The ABCD Worldwide EndoBarrier Registry, led by Dr Robert Ryder from the City Hospital in Birmingham, UK, collected data from 28 centres in eight countries throughout the world.

The first ABCD Worldwide EndoBarrier Registry benefit: risk data, was presented at the American Diabetes Association’s 78th Scientific Sessions in July 2018 by Ryder. Since then, the registry has more than doubled in the number of patient records, including the addition of the complete data set from the German EndoBarrier Registry. The Worldwide EndoBarrier Registry continues to support a positive benefit: risk profile for patients with type 2 diabetes and/or obesity treated with EndoBarrier.

“In this analysis of the Worldwide EndoBarrier Registry, the data highlights clinically significant reductions in HbA1c (1.2% absolute mean reduction) and weight (13.7kg mean reduction) as well as improvements in associated cardiovascular metrics (systolic BP: 7.4 mmHg reduction, cholesterol: 0.55 mmol/L reduction),” said Laubner. “When considering the overall clinical benefit of EndoBarrier treatment with the acceptable risk profile, the data combines to present a positive case for treatment of patients with type 2 diabetes and obesity.”

The data show significant reductions in HbA1c, weight, systolic blood pressure (BP) and cholesterol at time of EndoBarrier explant (Table 1).

Table 1

As expected, when comparing outcomes of HbA1c reduction, patients with a higher HbA1c at baseline show greater reductions at explant (Table 2).

Table 2

“All the data submitted from the 28 participating centres will continue to improve our efforts of evaluating the safety and efficacy of EndoBarrier,” said Ryder. “It is imperative for us, as clinicians, to push for new and innovative technologies, like EndoBarrier, to provide this patient population with alternative ways to help treat or manage their uncontrolled type 2 diabetes and obesity.”

“The Worldwide EndoBarrier Registry demonstrates the consistently positive impact EndoBarrier has from 28 clinical sites in eight countries throughout the world,” said Scott Schorer, president and chief executive office of GI Dynamics. “We are extremely grateful for the contributions these clinicians continue to make in support of our efforts to bring EndoBarrier to this patient population.”

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