1. Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition: the ReCharge Study.
- Author
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Morton JM, Shah SN, Wolfe BM, Apovian CM, Miller CJ, Tweden KS, Billington CJ, and Shikora SA
- Subjects
- Adult, Body Mass Index, Diabetes Mellitus, Type 2 complications, Double-Blind Method, Dyslipidemias complications, Female, Humans, Hypertension complications, Male, Middle Aged, Obesity complications, Treatment Outcome, Nerve Block methods, Obesity therapy, Vagus Nerve, Weight Loss physiology
- Abstract
Background: Vagal nerve blockade (vBloc) therapy was shown to be a safe and effective treatment for moderate to severe obesity. This report summarizes the safety and efficacy of vBloc therapy in the prespecified subgroup of patients with moderate obesity., Methods: The ReCharge Trial is a double-blind, randomized controlled clinical trial of participants with body mass index (BMI) of 40-45 or 35-40 kg/m(2) with at least one obesity-related comorbid condition. Participants were randomized 2:1 to implantation with either a vBloc or sham device with weight management counseling. Eighty-four subjects had moderate obesity (BMI 35-40 kg/m(2)) at randomization., Results: Fifty-three participants were randomized to vBloc and 31 to sham. Qualifying obesity-related comorbidities included dyslipidemia (73%), hypertension (58%), sleep apnea (33%), and type 2 diabetes (8%). The vBloc group achieved a percentage excess weight loss (%EWL) of 33% (11% total weight loss (%TWL)) compared to 19% EWL (6% TWL) with sham at 12 months (treatment difference 14 percentage points, 95% CI, 7-22; p < 0.0001). Common adverse events of vBloc through 12 months were heartburn/dyspepsia and implant site pain; the majority of events were reported as mild or moderate., Conclusions: vBloc therapy resulted in significantly greater weight loss than the sham control among participants with moderate obesity and comorbidities with a well-tolerated safety profile.
- Published
- 2016
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