Qsymia
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| Combination of | |
|---|---|
| Phentermine | Appetite suppressant/stimulant of the amphetamine and phenethylamine class |
| Topiramate | Anticonvulsant (extended release formulation is used) |
| Clinical data | |
| Pronunciation | Qsymia kyoo-sim-EE-uh |
| Trade names | Qsymia |
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| Routes of administration |
Oral |
| ATC code |
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| Legal status | |
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| PubChem CID | |
Phentermine and topiramate, sold under the trade name Qsymia, is a combination medication used for weight loss. Phentermine and topiramate is associated with modest weight loss when compared with placebo. This weight loss was associated with improvements in weight-related comorbidities such as improved blood sugar, decreased blood pressure, and improved cholesterol.
Phentermine and topiramate was developed by Vivus, a California pharmaceutical company.Phentermine is a sympathomimetic amine which acts as an appetite suppressant and stimulant.Topiramate is an anticonvulsant that has weight loss side effects. The exact mechanism of action for both drugs is unknown.
In 2012 the U.S. Food and Drug Administration approved phentermine/topiramate ER as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of at least 30 kg/m², or at least 27 kg/m² (overweight) in the presence of at least one weight-related comorbidity such as hypertension, type 2 diabetes mellitus, or dyslipidemia. Phentermine/topiramate ER is available in certified retail pharmacies nationwide and also available through a certified mail-order pharmacy network. Approval was denied by European regulatory authorities, who cited potential risk to the heart and blood vessels, psychiatric side effects, and cognitive side effects in explaining their decision.
In clinical trials, people treated with the highest dose of phentermine/topiramate ER in combination with a program of diet and exercise lost 10% to 11% of their body weight compared to 1% to 2% for those who received placebo. In addition, 62% to 70% of subjects receiving the recommended dose or top dose of phentermine/topiramate ER achieved ≥5% weight by week 56 (ITT-LOCF) compared to 17% to 21% of those receiving a placebo.
In clinical trials, the most common adverse events which occurred at a rate ≥5% and ≥1.5 times placebo included paraesthesia (tingling in fingers/toes), dizziness, dysgeusia (altered taste), insomnia, constipation, and dry mouth.
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