Vagal blocking therapy feasibility study results

|By:, SA News Editor

Harvard Medical School's Dr. Scott Shikora presents data from EnteroMedics' (ETRM +5.1%) 28-patient DM2 ENABLE study assessing the feasibility of VBLOC vagal block therapy delivered via its Maestro RC System as a treatment for obesity, hypertension and type 2 diabetes. His presentation will held at this week's International Federation for the Surgery of Obesity and Metabolic Disorders meeting in Montreal.

The open-label prospective study evaluated the safety and efficacy of VBLOC vagal block therapy delivered via the Maestro RC system as measured by average percent excess weight loss, HbA1c (blood sugar) levels, fasting plasma glucose and blood pressure.

At 36 months, HbA1c levels dropped from 7.6% to 7.0% albeit with a p value = 0.04 and above the 6.5% level that defines diabetes. Eighty-three percent of the patients being treated with one or more diabetic medications reported no change, a decrease or discontinuation in their medicines. The specific percentage that decreased/stopped their meds was undisclosed.

At 36 months, fasting plasma glucose decreased from 155.6 mg/dl at baseline to 131.5 mg/dl compared to the normal range of 70 - 100 mg/dl. Excess weight loss was 24.3%. Total weight loss, which would be a lower percentage, was unreported. Blood pressure improved -7.3 mm/Hg albeit with an unacceptably high p value = 0.14. Whether these are average or mean values is unknown.