2015-P: Endobarrier (EB) in Diabetes/Prediabetes with Obstructive Sleep Apnoea (OSA) Study: The Final Results

Abstract

Background/Aim: EB, a 60cm endoscopically implanted proximal intestinal liner is implanted for up to one year and then removed. We aimed to assess the extent to which patients with type 2 diabetes or prediabetes, obesity (BMI 30-45kg/m²) and moderate OSA requiring continuous positive airway pressure ventilation (CPAP) are able to discontinue CPAP following EB-related weight loss. Method: We assessed Apnoea Hypopnoea Index (AHI), weight and HbA1c before and during EB treatment and following its removal in the 12 patients with moderate OSA requiring continuous positive airway pressure ventilation (CPAP) {75% female, 8/12 (66%) type 2 diabetes, 4/12 (34%) prediabetes, mean ± SD age 52.6±9.7 years, BMI 37.4±3.5 kg/m², median duration of OSA while on CPAP 9.0(7.0-15.0) months}. Results: During the period of EB implantation, mean ± SD HbA1c fell by 1.26±0.7% from 7.9 ± 1.6 to 6.6 ± 0.9% (p=0.023), weight by 10.5±4.0 kg from 103.8± 14.1 to 93.3±13.7 kg (p<0.001) and AHI by 9.1±5.0 events/hour from 18.9±3.8 to 9.7±3.0 events/hour(p<0.001). Prior to EB, all patients had AHI in the National Institute for Health and Care Excellence (NICE) moderate OSA range (15-29.9 events/hour). During EB treatment the AHI of all 12 patients fell below 15 such that they no longer required CPAP according to NICE criteria. After EB removal, 10/12 (83%) patients attended follow up and at 12 months after removal, AHI remained below 15 in 5/10 (50%) patients but in the other 5 the AHI rose above 15 such that restarting CPAP was recommended. Two of these 5 patients, inspired by the desire to avoid CPAP, lost the regained weight and their AHI dropped below 15 again. Thus, 7/10 (70%) of patients were able to remain off CPAP 12 or more months after EB removal. Conclusion: These results demonstrate major benefit of EB in moderate OSA, allowing patients to discontinue CPAP with maintenance of improvement at follow up in 70% and confirm previously demonstrated metabolic improvements in diabesity. Disclosure M. Yadagiri: None. F.Y. Kinney: None. N. Ashman: None. J. Adams: None. M.C. Wyres: None. E.S. Sharratt: None. C. Greenwood: None. M.H. Lang: None. J. Bleasdale: None. E. Fogden: None. M. Anderson: None. C. Walton: Speaker’s Bureau; Spouse/Partner; Celgene, LEO Pharma, Novartis Pharmaceuticals Corporation. M.A. Greenstone: None. R.E. Ryder: Consultant; Self; GI Dynamics Inc. Other Relationship; Self; Novo Nordisk A/S.