Obesity Clinical Trial
Official title:
Qsymia as an Adjunct to Surgical Therapy in the Superobese
This study tests the efficacy of the medication, Qsymia, as an adjunct therapy in superobese individuals planning to undergo weight loss surgery. Individuals taking the medication before and after surgery will be compared to historical controls who had surgery without taking the medication.
While there is obvious focus on the obesity epidemic that affects approximately one-third of
the U.S. population, one subgroup within the epidemic remains on the fringe of scientific
study and effective treatment options. The super obese patient, in this instance defined as
those with a BMI ≥ 50 kg/m2, presents a difficult treatment challenge in managing this level
of obesity. While bariatric surgery, including Roux-en-Y gastric bypass and biliopancreatic
diversion with duodenal switch, have been shown to be effective in severe obesity (BMI ≥ 40
kg/m2), the risks involved with surgical intervention in the super obese patient are high.
Qsymia provides a potential opportunity to develop an effective treatment plan that would be
an adjunct to surgical intervention in the super obese patient. Use of Qsymia in addition to
a low-calorie dietary prescription pre-operatively would effectively decrease weight prior to
surgical intervention, lowering surgical risk to some extent. Additionally, if continued
post-operatively, Qsymia as an adjunct to the post-surgical dietary plan would potentially
extend the weight loss horizon so that the probability of the typical weight loss plateau at
12-18 months is decreased.
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