Surgery-less Gastric Bypass Improves Cardiac, Metabolic Risk Factors

Obese patients implanted with GI Dynamics' EndoBarrier lost an average of 49.5 pounds, and significantly reduced HbA1c and total cholesterol levels.

GI Dynamics announces data demonstrating that obese patients showed significant weight loss and cardiovascular and metabolic improvements with the company's EndoBarrier Gastrointestinal Liner. Following 12 months of therapy, patients lost an average of 20% of their body weight, or 49.5 pounds.

The EndoBarrier is a non-surgical therapy to treat type 2 diabetes and obesity approved for use in Europe and in advanced stages of clinical development in the United States.

These data were presented in an oral presentation at the International Federation for Surgery of Obesity and Metabolic Disorders 2010 World Congress in Los Angeles, CA. The clinical trial was designed to examine the safety and efficacy of the EndoBarrier in obese patients over 12 months.

Twenty-four obese patients with an average weight of 110.7 kg and average body mass index of 45.3 were successfully implanted with the EndoBarrier. The patients also exhibited baseline co-morbidities including type 2 diabetes, hypertension, dyslipidemia and metabolic syndrome.

At 12 months of treatment, patients achieved:

  • Mean absolute weight loss of 22.5 kg (49.5 lbs), or 20.0% (p = <0.0001)
  • Mean excess weight loss of 46.3%

Patients also experienced improvements in key cardiovascular risk factors:

  • Reduction in total cholesterol levels from 196.5 mg/dL at baseline to 161.0 mg/dL (p = <0.0001)
  • Reduction in diastolic blood pressure from 84.8 mmHg at baseline to 71.2 mmHg (p= <0.0001)

Notably, data from a subset of six patients with type 2 diabetes with mean baseline HbA1c of 7.9% showed that patients achieved a mean reduction in HbA1c of 1.4 (p=0.05) following 12 months of treatment.

Source: GI Dynamics