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Qsymia is a federally controlled substance (CIV) because it contains phentermine and can be abused or lead to drug dependence. Keep Qsymia in a safe place, to protect it from theft. Never give your Qsymia to anyone else, because it may cause death or harm them. Selling or giving away this medicine is against the law.
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QSYMIA SUMMARY
Qsymia capsule is a combination oral product comprised of immediate-release phentermine hydrochloride (as the free base) and extended-release topiramate. Qsymia contains phentermine hydrochloride, a sympathomimetic amine anorectic and topiramate, a sulfamate-substituted monosaccharide related to fructose antiepileptic drug.
Qsymia is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of
- 30 kg/m2 or greater (obese), or
- 27 kg/m2 or greater (overweight) in the presence of at least one weight related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia
Limitations of Use
- The effect of Qsymia on cardiovascular morbidity and mortality has not been established.
- The safety and effectiveness of Qsymia in combination with other products intended for weight loss, including prescription and over-the-counter drugs and herbal preparations have not been established.
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NEWS HIGHLIGHTS
Published Studies Related to Qsymia (Phentermine / Topiramate)
Phentermine/topiramate for weight reduction and treatment of adverse metabolic
consequences in obesity. [2011]
Phentermine hydrochloride is a noradrenergic sympathetic amine approved for
decades by the U.S...
Clinical Trials Related to Qsymia (Phentermine / Topiramate)
Peripheral Pharmacodynamics of Phentermine-Topiramate in Obese Patients [Completed]
Qsymia as an Adjunct to Surgical Therapy in the Superobese [Recruiting]
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.
Effect of VI-0521 (QsymiaŽ) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects [Completed]
The main purpose of this study is measure the effect of VI-0521 on kidney function.
Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks
of study treatment, and after an additional 4 weeks of off-treatment recovery.
A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787) [Completed]
The purpose of this study is to evaluate the long-term safety and efficacy of VI-0521
compared to placebo for the treatment of overweight and obesity in adults who have completed
study OB-303 (NCT00553787) at selected study sites. This is an extension study of protocol
OB-303 (NCT00553787).
A Toolbox Approach to Obesity Treatment in Primary Care [Active, not recruiting]
Obesity is common, causing many medical problems in adults (e. g., diabetes, hypertension,
high cholesterol, sleep apnea, heart attack, strokes). A range of treatments have shown to
be effective for treating obesity. Treatments include lifestyle modification, meal
replacements, and weight loss medication. Most primary care settings do not provide much
obesity treatment, though, as primary care providers (PCPs) are not well trained and because
reimbursement for treatments is not consistent.
Hypothesis: If PCPs have training in weight management and if most costs of treatment are
reimbursed, we surmise that a "toolbox" of treatments can produce a clinically important
weight loss amount in a large group of patients.
Design: We propose to establish a registry of obese patients with at least one common
medical condition related to their weight. From the registry, we will randomly select 350
people to be offered treatments to assist with weight loss. The remainder of the registry's
patients can still receive obesity treatment but will not be reimbursed. We will conduct
the study at Denver Health, a large public health care system that treats a low income,
ethnically diverse population. All 350 patients will be offered some self-monitoring tools
for weight management and the chance to do a computer assessment to select the right
treatment for weight loss. Patients who complete this and record their food intake and
physical activity for 1 week will be offered a "Level 2" treatment for weight loss. Level 2
treatments include: a voucher for a commercial weight loss program; intensive group weight
loss counseling; meal replacements; gym membership; or weight loss medication. Patients
will choose which treatment they want, with the approval of their PCP. Researchers at
Denver Health will help with the computer assessment and dispensing the treatments. We are
interested in what percentage of patients lose at least 5% of their starting weight. We
will also explore changes in glucose, blood pressure, and cholesterol, and we will look at
how much this intervention costs and whether patients need less medication for their
weight-related conditions at the end of the study.
Impact: If the study is successful, we plan to take the results to the leaders at Denver
Health to see if they will make obesity treatment more broadly available for all patients
there.
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Page last updated: 2013-02-10
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