Matusow: As I recall the other day, we spoke about the drawbacks of drug treatments. Can we cover that again for the readers?
Dr. Trinh: Sure, although most patients do lose weight during their active participation in these programs, from my experience the results are usually not long term. The problem I've witnessed is a lack of long term behavioral changes in exercise and good eating habits. When the diet plan ends, we tend to revert back to our original habits that caused weight gain in the first place. As a result, the pounds come back.
The age long belief that preventing obesity boils down to simple exercise and healthy diet remains true, but the facts point out that teaching diet and exercise alone have been ineffective. If it was effective, we would not see a continuous rise of obesity in our culture. This article would not exist. It's obvious that something different needs to be done in order to reverse this trend.
Up to now there hasn't been a very good option at tackling weight loss. Surgeries are invasive, diet pills have systemic side effects and not long term, and weight loss plans come and go without consistency.
Now, let's take a further look at EnteroMedics and its flagship treatment and device, The Maestro System.
Unlike gastric bypass, the placement of this device is not done through invasive surgery, but rather laproscopically. The device attaches with two leads which innervates the vagal nerve. Despite how dangerous it may sound, no significant safety issues have been reported to date. The device also preserves normal digestive system anatomy and the may be adjusted, deactivated, reactivated, or entirely removed at any given point in time.
The EMPOWER study:
The EMPOWER study was a randomized, double-blind, controlled study of 252 patients designed to test the safety and efficacy of the company's first generation Maestro RF System. Both groups were implanted the Maestro Rechargable System but only the treatment group the system was activated to inhibit the vagus nerve on an intermittent basis.
The Detailed Preliminary Results reported in November 2009 showed that the Maestro system did meet its safety endpoint but failed to meet the primary and secondary endpoints for efficacy. Such results significantly impacted the company as the stock saw significant losses to the downside.
•Patients who met or exceeded the prescribed nine hours of daily device use (n=128, 51% of evaluated patients) averaged 10.9 hours of daily use and experienced an average excess weight loss (EWL) of 23.1% from implant by BMI method (18.3% from treatment initiation by Met Life method) in the treatment arm and 22.6% (BMI) from implant, (17.8% from initiation, Met Life) in the control arm at 12 months.
•Patients that did not meet the prescribed nine hours of daily device use (n=125) averaged 6.9 hours of daily use and experienced a mean EWL of 10.5% from implant in the treatment arm (6.4% from initiation, Met Life) and 8.6% in the control arm (4.6% from initiation, Met Life) at 12 months.
•For all patients (n=253), the average EWL at 12 months was 16.6% EWL from implant (12.1% from initiation, MetLife) for the treatment arm and 16.4% EWL from implant (12.0% from initiation, MetLife) for the control arm.
•For those patients with a diagnosis of hypertension (n=110), a statistically significant reduction of systolic and diastolic blood pressure from baseline was observed, a result that will require follow-up study.
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