Format

Send to

Choose Destination
Obes Surg. 2016 May;26(5):983-9. doi: 10.1007/s11695-016-2143-y.

Effect of Vagal Nerve Blockade on Moderate Obesity with an Obesity-Related Comorbid Condition: the ReCharge Study.

Author information

1
Stanford School of Medicine, Stanford, CA, USA.
2
Tufts Medical Center, Boston, MA, USA.
3
Oregon Health & Science University, Portland, OR, USA.
4
Boston University, Boston, MA, USA.
5
3D Communications, LLC, Raleigh, NC, USA.
6
EnteroMedics Inc, St Paul, MN, USA. ktweden@enteromedics.com.
7
University of Minnesota, Minneapolis, MN, USA.
8
EnteroMedics Inc, St Paul, MN, USA.
9
Brigham and Women's Hospital, Boston, MA, USA.

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.

KEYWORDS:

Active implantable medical device; Bariatric surgery; Laparoscopic surgery; Moderate obesity; Obesity; Randomized controlled trial; Vagal nerve blocking

PMID:
27048437
PMCID:
PMC4831996
DOI:
10.1007/s11695-016-2143-y
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Springer Icon for PubMed Central
Loading ...
Support Center