EnteroMedics (ETRM) Announces Publication of Positive ReCharge Clinical Study Data
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EnteroMedics Inc. (NASDAQ: ETRM) announced the publication of 24 month results from the Company's ReCharge Clinical Study. The article, titled "Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial," was published in Obesity Surgery (DOI: 10.1007/s11695-016-2325-7), and is available online here.
"The ability to sustain meaningful weight loss is vital when considering a viable long term solution for treating obesity and its related comorbidities," said Caroline M. Apovian, MD, FACP, FACN, Director, Nutrition and Weight Management, Professor of Medicine at Boston University School of Medicine, and lead author of the article. "vBloc has consistently set itself apart, demonstrating sustained weight loss combined with a compelling safety profile. These findings underscore vBloc Therapy's potential to serve as a favorable, effective therapy in patients struggling with obesity who prefer not to undergo an anatomy-altering or lifestyle-restricting bariatric procedure."
Durable Weight Loss
The ReCharge Pivotal Trial is a randomized, double-blind, sham-controlled, multicenter pivotal clinical trial of vBloc Neurometabolic Therapy in 239 patients with obesity. At 24 months, 76% percent of the randomized vBloc participants (n=123) remained in the trial. The mean excess weight loss (EWL) among vBloc participants who presented for their 24-month visit was 21%, with a mean percent total weight loss (TWL) of 8%. Of the 24 Sham control patients who had not yet crossed over to vBloc at 24 months, the EWL and TWL was 4% and 1%, respectively. The authors noted that comparative randomized controlled trials for conventional bariatric procedures demonstrated only 6% TWL for laparoscopic adjustable gastric banding (LAGB) at the same time point. Patients' quality of life improvements, as measured by the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) questionnaire, were shown to be durable with a sustained increase of 20 units from their preoperative level, and the Three-Factor Eating Questionnaire (TFEQ) showed that patients continued to have a 50% reduction in hunger.
Among participants with pre-diabetes or metabolic syndrome at baseline, approximately 50% demonstrated resolution of pre-diabetes or metabolic syndrome at 24 months compared to baseline. Among the subset of participants with abnormal cardiovascular or metabolic conditions at baseline, statistically significant improvements were observed in mean low density lipoprotein (LDL) cholesterol (−16 mg/dL) and high density lipoprotein (HDL) cholesterol (+4 mg/dL), triglycerides (−46 mg/dL), systolic (−11 mmHg) and diastolic blood pressures (−10 mmHg), and hemoglobin A1c (HbA1c) (−0.3 %).
The authors noted that the safety profile of vBloc Therapy remained favorable at 24 months compared to complications observed with conventional bariatric procedures such as sleeve gastrectomy and gastric bypass. Ninety-four percent of all adverse events were reported as mild or moderate in severity, and 83% of events had resolved by 24 months. Three serious adverse events were reported and adjudicated by the independent clinical events committee to be unrelated to vBloc therapy.
"Without altering the anatomy of the gastrointestinal system, vBloc's potential for serious adverse events is minimal, and the ReCharge study helps solidify this important fact. vBloc's safety profile may serve as a future benchmark for obesity treatment options," said Scott A. Shikora, MD, FACS, Chief Medical Officer of EnteroMedics.
"These findings are crucial as we continue to advance towards our goals of both expanding the reach of this proven technology, as well as obtaining reimbursement for patients in need," says Dan Gladney, Chief Executive Officer of EnteroMedics. "These results, in combination with the first-hand patient success stories we've had the privilege of learning about, leave us confident that vBloc combined with the vBloc Achieve program, a comprehensive, personalized weight loss support program to help vBloc patients reach and maintain health goals, hold strong potential to serve as a highly effective option in patients in dire need of new approaches to treat their obesity."
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