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

الملخص EN

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.