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EndoBarrier sleep apnoea study

EndoBarrier sleep apnoea study shows significant improvements

The End-OSA study is a single-centre clinical trial, initiated and funded by the Association of British Clinical Diabetologists (ABCD)

GI Dynamics announced positive data, presented at the American Diabetes Association’s 79th Scientific Sessions in San Francisco, CA, showing significant improvements in HbA1c, weight and BMI. The abstract, ‘EndoBarrier in Type 2 Diabetes/Pre-Diabetes with Obstructive Sleep Apnoea (OSA) Study - Maintenance of Improvement after EndoBarrier Removal’, otherwise known as the End-OSA study, was resented by Dr Mahender Yadagiri of City Hospital in Birmingham, UK.

“These results confirm previously demonstrated metabolic improvements from EndoBarrier in diabesity and demonstrate major benefit for patients with moderate OSA,” said Yadagiri. “Discontinuing CPAP is not only beneficial to health services but especially to patients.”

The End-OSA study is a single-centre clinical trial, initiated and funded by the Association of British Clinical Diabetologists (ABCD) based in City Hospital of Sandwell and West Birmingham Hospitals, Birmingham, UK. It is a clinical investigational study of EndoBarrier used to treat patients with moderate obstructive sleep apnoea (OSA) who have type 2 diabetes or pre-diabetes over a 24-month period. Patients were implanted with EndoBarrier for up to 12 months, followed by additional clinical visits to gather post explant data for up to 12 months after EndoBarrier explantation.

Patients included in the study had moderate OSA [Apnea Hypopnea Index (AHI) 15 – 29 events/hour] treated with continuous positive airway pressure (CPAP), type 2 diabetes or pre-diabetes, obesity (BMI≥30 and ≤45) and ≥18 years of age. The End-OSA study’s primary endpoint was the reduction in number of AHI events – the sum of hypopneas and apnoea’s as measured by average occurrence each hour of rest.

The data shows significant improvements in AHI events per hour, HbA1c, weight, and BMI. During EndoBarrier treatment, all ten patients were able to decrease their AHI events from a mean of 18.8 events per hour to below 15 events per hour, putting them below the threshold to require CPAP per the National Institute for Health and Care Excellence (NICE) guidelines.

The follow-up data was collected at a mean (range) of 9.7 (3 – 17.6) months after EndoBarrier explant. At this latest data point, AHI was below 15 events per hour for all patients such that they remained off CPAP.

“The End-OSA study highlights one of the clinical effects on a comorbidity associated with type 2 diabetes and obesity and underscores the growing body of evidence supporting safe and effective treatment with EndoBarrier,” said Scott Schorer, president and chief executive officer of GI Dynamics. “We look forward to additional clinical data releases from other leading clinicians’ investigator-initiated clinical studies.”

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