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J Obes. 2015;2015:365604. doi: 10.1155/2015/365604. Epub 2015 Jul 12.

Sustained Weight Loss with Vagal Nerve Blockade but Not with Sham: 18-Month Results of the ReCharge Trial.

Author information

1
Division of General and Gastrointestinal Surgery, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA ; EnteroMedics Inc., 2800 Patton Road, St. Paul, MN 55113, USA.
2
Department of Surgery, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.
3
Department of Medicine, Section of Endocrinology, Diabetes and Nutrition, Boston University School of Medicine, 88 East Newton Street, Boston, MA 02118, USA.
4
Department of Surgery, McMaster University, 1280 Main Street West, Hamilton, ON, Canada L8S4L8.
5
Departments of Psychiatry and Surgery, Perelman School of Medicine, Hospital of the University of Pennsylvania, 3535 Market Street, Philadelphia, PA 19104, USA.
6
Departments of Medicine and Public Health Sciences, University of Chicago, 5841 S. Maryland Avenue, Chicago, IL 60637, USA.
7
Department of Surgery, University of Minnesota, University of Minnesota Medical Center, 420 Delaware Street SE, Minneapolis, MN 55455, USA.
8
3D Communications LLC, 8386 Six Forks Road, Raleigh, NC 27615, USA.
9
EnteroMedics Inc., 2800 Patton Road, St. Paul, MN 55113, USA.
10
Department of Gastroenterologic and General Surgery, Mayo Clinic Rochester, 200 First Street SW, Rochester, MN 55905, USA.
11
Division of Endocrinology and Diabetes, University of Minnesota, Minneapolis, Minnesota Veterans' Administration Medical Center, One Veterans Drive, Minneapolis, MN 55417, USA.

Abstract

BACKGROUND/OBJECTIVES:

Vagal block therapy (vBloc) is effective for moderate to severe obesity at one year.

SUBJECTS/METHODS:

The ReCharge trial is a double-blind, randomized controlled clinical trial of 239 participants with body mass index (BMI) of 40 to 45 kg/m or 35 to 40 kg/m with one or more obesity-related conditions. Interventions were implantation of either vBloc or Sham devices and weight management counseling. Mixed models assessed percent excess weight loss (%EWL) and total weight loss (%TWL) in intent-to-treat analyses. At 18 months, 142 (88%) vBloc and 64 (83%) Sham patients remained enrolled in the study.

RESULTS:

18-month weight loss was 23% EWL (8.8% TWL) for vBloc and 10% EWL (3.8% TWL) for Sham (P < 0.0001). vBloc patients largely maintained 12-month weight loss of 26% EWL (9.7% TWL). Sham regained over 40% of the 17% EWL (6.4% TWL) by 18 months. Most weight regain preceded unblinding. Common adverse events of vBloc through 18 months were heartburn/dyspepsia and abdominal pain; 98% of events were reported as mild or moderate and 79% had resolved.

CONCLUSIONS:

Weight loss with vBloc was sustained through 18 months, while Sham regained weight between 12 and 18 months. vBloc is effective with a low rate of serious complications.

PMID:
26246907
PMCID:
PMC4515300
DOI:
10.1155/2015/365604
[Indexed for MEDLINE]
Free PMC Article

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