18 Aug Vagal Nerve Blocking (vBloc) for the Treatment of Obesity Demonstrates Meaningful Weight Loss
MedicalResearch.com Interview with:
Katherine Tweden Ph.D.
Vice President, Clinical and Regulatory
St. Paul, Minnesota 55113
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: This report summarizes 2 year outcomes of the pivotal study that evaluated the safety and efficacy of EnteroMedics’ vagal blockade (vBloc Therapy) delivered by our Maestro Rechargeable System neuromodulation device for the treatment of obesity. The study demonstrates that the device continues to have a promising safety profile and that the weight loss achieved through 2 years is clinically meaningful as shown by the positive impact of vBloc Therapy on participant’s co-morbid conditions, quality of life, and eating behaviors.
Specifically, the study showed 21% excess weight loss and approximately 50% reduction in pre-diabetes and metabolic syndrome for those participants who presented with the syndrome at baseline.
In addition, cardiovascular parameters improved in those at risk with approximately 10 mmHg drop in systolic and diastolic blood pressure compared to baseline in participants with elevated blood pressure and 16 and 46 mg/dL drop in LDL and triglycerides, respectively, in participants with elevated lipids compared to baseline. In addition, metabolic parameters improved with a reduction in hemoglobin A1c of 0.3 percentage points. Participants’ quality of life improved by 20 units compared to baseline and their control over their eating behavior, such as hunger and the ability to control the amount they eat, was significantly improved by approximately 50% compared to baseline.
MedicalResearch.com: What should readers take away from your report?
Response: That EnteroMedics’ vBloc therapy is a viable and safer alternative to more invasive bariatric surgeries and helps improve patient’s health and quality of life.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Future research should center around “mechanism of action” studies.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Obes Surg. 2016 Aug 10. [Epub ahead of print]
Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial.
Apovian CM1, Shah SN2, Wolfe BM3, Ikramuddin S4, Miller CJ5, Tweden KS6, Billington CJ7, Shikora SA8.
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
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Last Updated on August 18, 2016 by Marie Benz MD FAAD