title: Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition: the ReCharge Study.
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.
authors.affiliation: Stanford School of Medicine, Stanford, CA, USA.
authors.forename: John M
authors.initials: JM
authors.lastname: Morton
authors.affiliation: Tufts Medical Center, Boston, MA, USA.
authors.forename: Sajani N
authors.initials: SN
authors.lastname: Shah
authors.affiliation: Oregon Health & Science University, Portland, OR, USA.
authors.forename: Bruce M
authors.initials: BM
authors.lastname: Wolfe
authors.affiliation: Boston University, Boston, MA, USA.
authors.forename: Caroline M
authors.initials: CM
authors.lastname: Apovian
authors.affiliation: 3D Communications, LLC, Raleigh, NC, USA.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Miller
authors.affiliation: EnteroMedics Inc, St Paul, MN, USA. ktweden@enteromedics.com.
authors.forename: Katherine S
authors.initials: KS
authors.lastname: Tweden
authors.affiliation: University of Minnesota, Minneapolis, MN, USA.
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Billington
authors.affiliation: EnteroMedics Inc, St Paul, MN, USA.|Brigham and Women's Hospital, Boston, MA, USA.
authors.forename: Scott A
authors.initials: SA
authors.lastname: Shikora
mesh_terms: D000328:Adult; D015992:Body Mass Index; D003924:Diabetes Mellitus, Type 2 / Q000150:complications; D004311:Double-Blind Method; D050171:Dyslipidemias / Q000150:complications; D005260:Female; D006801:Humans; D006973:Hypertension / Q000150:complications; D008297:Male; D008875:Middle Aged; D009407:Nerve Block / Q000379:methods*; D009765:Obesity / Q000150:complications / Q000628:therapy*; D016896:Treatment Outcome; D014630:Vagus Nerve; D015431:Weight Loss / Q000502:physiology*
keywords: Active implantable medical device; Bariatric surgery; Laparoscopic surgery; Moderate obesity; Obesity; Randomized controlled trial; Vagal nerve blocking