The primary endpoint of the study was to demonstrate significantly greater "excess weight loss" (EWL) in the VBLOC treatment group compared to the control after 12 months.
EWL was calculated as a percentage equal to total weight loss in the trial (the numerator) divided by the difference in baseline weight and "ideal weight" using a BMI of 25 (the denominator.)
Initial EMPOWER study results were first reported in 2009 and published fully in Obesity Surgery three years later. The EWL for VBLOC-treated patients was 17% compared to 16% for control patients. Clearly, there was no statistically significant difference at all in excess weight loss between the two groups.
EnteroMedics has never disclosed or published actual numerical weight loss data from the EMPOWER study. However, if I use the same 5' 4" woman weighing 240 pounds as a typical patient, a 17% EWL translates into weight loss of 16 pounds, or 6.7% from baseline. That's slightly better than what you'd expect to see from Arena's Belviq but less than Vivus' Qsymia.The sham device's 16% EWL translated into 15 pounds of weight loss, or 6.3%.
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