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Orbera and NASH

Orbera associated with metabolic and NASH improvements

Weight loss achieved with the single-fluid intragastric balloon is associated with significant metabolic improvement and regression of NASH

The results from an FDA-approved, prospective open-label study of the Orbera Intragastric Balloon in patients with Nonalcoholic Steatohepatitis (NASH) has showed significant benefits of weight loss in patients with NASH and nonalcoholic fatty liver disease (NAFLD). The abstract, ‘Impact of single fluid-filled intragastric balloon on metabolic parameters and nonalcoholic steatohepatitis: a prospective paired endoscopic ultrasound guided core liver biopsy at the time of balloon placement and removal’, was presented at Digestive Disease Week 2018.

This study was led by Dr Barham Abu Dayyeh, a Gastroenterology Consultant and director of the bariatric and metabolic endoscopy program at the Mayo Clinic (Rochester, MN) and presented by Dr Fateh Bazerbachi.

Orbera is an incision-less, non-surgical weight loss solution designed for adult patients suffering from obesity, who are not appropriate for or considering invasive surgery, but for whom diet and exercise or pharmaceutical interventions have not worked.

In the endoscopic procedure, the thin and deflated Orbera balloon is placed into the stomach. It is then filled with saline until it’s about the size of a grapefruit. The procedure typically takes about 20 to 30 minutes and the patient can generally go home the same day. At six months, through another non-surgical procedure, the Orbera balloon is deflated and then removed.  Once the balloon is in place, the patient receives an individually tailored support program through the Orbera Managed Weight Loss System team of experts to help keep them motivated, coordinate their program and help them work through weight loss barriers to meet their long-term weight loss goals. Coaching takes place over 12 months, even though the balloon is removed after six months. The program is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.

Nonalcoholic Steatohepatitis (NASH) with early fibrosis is serious condition that afflicts a significant portion of patients with obesity with the potential to progress to cirrhosis. The degree of weight loss is independently associated with improvements in all NASH-related histologic parameters when a threshold of ≥ 10% of total body weight (%TBWL) is achieved. Only the minority of patients can reach this threshold with non-surgical obesity interventions.

The Mayo study combined a paired endoscopic ultrasound-guided core liver biopsy (EUS-LB) at the time of Orbera IGB placement and removal. All patients had NASH with early fibrosis diagnosed by Magnetic Resonance Elastography (MRE) and the MRE was repeated after balloon removal. All biopsies and MREs were evaluated by an experienced liver pathologist and radiologist, respectively, both blinded to the clinical status and data of the patient.

Outcomes

The results revealed that at time of balloon removal patients lost an average of 12.8±5.3% TBWL and was associated with significant improvement in their metabolic profile with decrease in HbA1c (7.5±0.4 to 6.3±0.3; p=0.004) and central obesity (waist circumference decreased by 8.6±13 cm; p=0.02). In addition, radiologic metabolic components and liver stiffness improved significantly on repeat MRE (Figure 1). NASH activity score (NAS), on liver biopsy, improved in 87% of patients with a median decrease of 3 points (range: 1, 4). Seventy three percent of patient achieved ≥2 points improvement in NAS. Overall, fibrosis regressed in 20% of patients.

Figure 1: The radiologic metabolic components and liver stiffness measured by MRE before and after balloon placement

All patients with early fibrosis (stages 1A, 1B, and 1C) regressed, and AST and AST to platelet ratio (APRI score), respectively, improved significantly (75.15±13 vs. 25±5; p=0.001; 1.5±0.4 vs. 0.6±0.2; p=0.001). EUS-LB related adverse events occurred in 5% of procedures and were restricted to post-procedural pain without bleeding. One patient stopped their use of anti-thrombotics against medical recommendations and suffered from a coronary event one month after IGB placement.

“This study provides conclusive evidence that weight loss achieved with the single-fluid intragastric balloon is associated with significant metabolic improvement and regression of NASH; thus providing a safe and effective tool to manage this disease when combined with weight maintenance strategy after balloon removal,” the study authors concluded.

Overall, the study revealed that:

  • 65% of patients achieved resolution of NASH on biopsy
  • 80% of patients had a ≥2 point improvement in NAFLD activity score
  • 15% had tissue evidence indicating regression of fibrosis (scarring), despite the relatively short period of the study

“The disease improvement seen in this study is very significant and was achieved in the majority of patients. These types of results are rare because fatty liver disease and NASH are difficult to treat, with weight loss being the primary treatment option. Typical weight loss efforts only help a small percentage of patients achieve the 7-10% TBWL required to see improvements in the disease,” said Dr Christopher Gostout, Chief Medical Officer at Apollo. “Furthermore, the authors found a very significant decrease in mesenteric fat thickness, which was robustly associated with severity of the liver inflammation. Mesenteric fat represents the fat around the actual visceral organs and is thought to be a culprit in the development of inflammation in fatty liver disease. The results from this study highlight that the Orbera balloon and weight management programs can safely provide substantial clinical value for liver disease patients.”

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