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

Abstract

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/m2, or 35 to 40 kg/m2 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://ichgcp.net/clinical-trials-registry/NCT01327976.

Keywords: Obesity; Quality of life; Vagal nerve blocking; Weight loss surgery.

Conflict of interest statement

The role of the Funder/Sponsor EnteroMedics Inc. was involved in the design and conduct of the study, site selection, and database management. The sponsor provided funding to the clinical sites for patient enrollment, core laboratory analyses, clinical events adjudications, and database entry. Author 1: sponsor provided fees for assistance in preparing and presenting these data to an independent FDA advisory committee. Author 2: sponsor provided fees for surgeon training outside of the study conduct. Author 3 and 4: sponsor provided fees for assistance in preparing and presenting these data to an independent FDA advisory committee. Author 5: sponsor provided fees for data analysis and critical revision of manuscript. Author 6 and 8: sponsor representatives allowed to review and participate in critical revision of manuscript. Author 7: sponsor provided consulting fees for oversight of the trial (National PI). Ethics Statements All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study.