Qsymia as an Adjunct to Surgical Therapy in the Superobese

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.

Inclusion Criteria:

- BMI ≥ 50 kg/m2

- Determined to be a good candidate for surgery based on medical and psychological exam.

- Willing to participate in a 3-6 month medically supervised weight loss plan prior to
surgery.

- Planning to remain in the reasonable vicinity of the Wake Forest Baptist Health -
Weight Management Center for the duration of the study.

Exclusion Criteria:

- History of prior weight loss surgery (removal/conversion from band to sleeve will not
be excluded)

- Pregnant (women of childbearing potential will complete a pregnancy test (blood draw)
to make sure they are not pregnant at the time that they initiate the medication).
Ongoing monitoring of pregnancy status is the responsibility of the patient and they
are instructed as such in the consent form.

- Ongoing use of weight loss medication

- Contraindications to use of Qsymia, including pregnancy, history of glaucoma, unstable
cardiac disease (unstable angina, recent heart attack or stroke (in the past 6
months), uncontrolled arrhythmia), hyperthyroidism, taking MAOIs (monoamine oxidase
inhibitors) or allergy to either topiramate or sympathomimetic amines like
phentermine.