Lexington, MA based GI Dynamics has announced results of a clinical trial of its gastrointestinal liner, in which patients treated with the EndoBarrier lost an average of 20 percent of their body weight over one year following implantation. In addition to weight loss, the patients also showed lower blood pressure and reduced cholesterol levels.
These data were presented in an oral presentation this week at the International Federation for Surgery of Obesity and Metabolic Disorders (IFSO) 2010 World Congress in Los Angeles, Calif. 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 (BMI) 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 with the EndoBarrier, patients achieved:
• Mean absolute weight loss of 22.5 kg (49.5 lbs), or 20.0% (p = <0.0001)
• Mean excess weight loss (EWL) of 46.3%
Patients also experienced the following 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)
Press release: GI Dynamics Announces New Data Showing Significant Weight Loss, Cardiovascular and Metabolic Improvements Following 12 Months of EndoBarrier™ Treatment…
Product page: EndoBarrier…
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