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Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial

BACKGROUND: The ReCharge Trial demonstrated that a vagal blocking device (vBloc) is a safe and effective treatment for moderate to severe obesity. This report summarizes 24-month outcomes. METHODS: Participants with body mass index (BMI) 40 to 45 kg/m(2), or 35 to 40 kg/m(2) with at least one comorb...

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Autores principales: Apovian, Caroline M., Shah, Sajani N., Wolfe, Bruce M., Ikramuddin, Sayeed, Miller, Christopher J., Tweden, Katherine S., Billington, Charles J., Shikora, Scott A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5187356/
https://www.ncbi.nlm.nih.gov/pubmed/27506803
http://dx.doi.org/10.1007/s11695-016-2325-7
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author Apovian, Caroline M.
Shah, Sajani N.
Wolfe, Bruce M.
Ikramuddin, Sayeed
Miller, Christopher J.
Tweden, Katherine S.
Billington, Charles J.
Shikora, Scott A.
author_facet Apovian, Caroline M.
Shah, Sajani N.
Wolfe, Bruce M.
Ikramuddin, Sayeed
Miller, Christopher J.
Tweden, Katherine S.
Billington, Charles J.
Shikora, Scott A.
author_sort Apovian, Caroline M.
collection PubMed
description BACKGROUND: The ReCharge Trial demonstrated that a vagal blocking device (vBloc) is a safe and effective treatment for moderate to severe obesity. This report summarizes 24-month outcomes. METHODS: Participants with body mass index (BMI) 40 to 45 kg/m(2), or 35 to 40 kg/m(2) with at least one comorbid condition were randomized to either vBloc therapy or sham intervention for 12 months. After 12 months, participants randomized to vBloc continued open-label vBloc therapy and are the focus of this report. Weight loss, adverse events, comorbid risk factors, and quality of life (QOL) will be assessed for 5 years. RESULTS: At 24 months, 123 (76 %) vBloc participants remained in the trial. Participants who presented at 24 months (n = 103) had a mean excess weight loss (EWL) of 21 % (8 % total weight loss [TWL]); 58 % of participants had ≥5 % TWL and 34 % had ≥10 % TWL. Among the subset of participants with abnormal preoperative values, significant improvements were observed in mean LDL (−16 mg/dL) and HDL cholesterol (+4 mg/dL), triglycerides (−46 mg/dL), HbA1c (−0.3 %), and systolic (−11 mmHg) and diastolic blood pressures (−10 mmHg). QOL measures were significantly improved. Heartburn/dyspepsia and implant site pain were the most frequently reported adverse events. The primary related serious adverse event rate was 4.3 %. CONCLUSIONS: vBloc therapy continues to result in medically meaningful weight loss with a favorable safety profile through 2 years. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01327976
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spelling pubmed-51873562017-01-12 Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial Apovian, Caroline M. Shah, Sajani N. Wolfe, Bruce M. Ikramuddin, Sayeed Miller, Christopher J. Tweden, Katherine S. Billington, Charles J. Shikora, Scott A. Obes Surg Original Contributions BACKGROUND: The ReCharge Trial demonstrated that a vagal blocking device (vBloc) is a safe and effective treatment for moderate to severe obesity. This report summarizes 24-month outcomes. METHODS: Participants with body mass index (BMI) 40 to 45 kg/m(2), or 35 to 40 kg/m(2) with at least one comorbid condition were randomized to either vBloc therapy or sham intervention for 12 months. After 12 months, participants randomized to vBloc continued open-label vBloc therapy and are the focus of this report. Weight loss, adverse events, comorbid risk factors, and quality of life (QOL) will be assessed for 5 years. RESULTS: At 24 months, 123 (76 %) vBloc participants remained in the trial. Participants who presented at 24 months (n = 103) had a mean excess weight loss (EWL) of 21 % (8 % total weight loss [TWL]); 58 % of participants had ≥5 % TWL and 34 % had ≥10 % TWL. Among the subset of participants with abnormal preoperative values, significant improvements were observed in mean LDL (−16 mg/dL) and HDL cholesterol (+4 mg/dL), triglycerides (−46 mg/dL), HbA1c (−0.3 %), and systolic (−11 mmHg) and diastolic blood pressures (−10 mmHg). QOL measures were significantly improved. Heartburn/dyspepsia and implant site pain were the most frequently reported adverse events. The primary related serious adverse event rate was 4.3 %. CONCLUSIONS: vBloc therapy continues to result in medically meaningful weight loss with a favorable safety profile through 2 years. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01327976 Springer US 2016-08-10 2017 /pmc/articles/PMC5187356/ /pubmed/27506803 http://dx.doi.org/10.1007/s11695-016-2325-7 Text en © The Author(s) 2016 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Original Contributions
Apovian, Caroline M.
Shah, Sajani N.
Wolfe, Bruce M.
Ikramuddin, Sayeed
Miller, Christopher J.
Tweden, Katherine S.
Billington, Charles J.
Shikora, Scott A.
Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial
title Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial
title_full Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial
title_fullStr Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial
title_full_unstemmed Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial
title_short Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial
title_sort two-year outcomes of vagal nerve blocking (vbloc) for the treatment of obesity in the recharge trial
topic Original Contributions
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5187356/
https://www.ncbi.nlm.nih.gov/pubmed/27506803
http://dx.doi.org/10.1007/s11695-016-2325-7
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