麻豆传媒

The FDA approved for phentermine/topiramate extended-release capsules (Qsymia) for chronic weight management in adolescents ages 12 and older with obesity, defined as a body mass index (BMI) in the 95th percentile or higher.

The drug originally received FDA approval in July 2012 for adults with overweight or obesity and at least one comorbidity related to weight, and is recommended alongside an increase in physical activity and a reduced-calorie diet in both adults and teens.

, 19.7% of adolescents ages 12 to 19 have obesity, which has negative impacts on their present health, as well as their future health.

The FDA noted that children with obesity often reach adulthood with obesity. While lifestyle modification is initially recommended, medication may be considered in cases where interventions are unsuccessful.

The efficacy and safety of phentermine/topiramate were evaluated in a 56-week, double-blind, placebo-controlled study of 223 adolescents ages 12 to 16 with a very high BMI, who were unsuccessful at losing weight or maintaining weight loss with exercise and diet alone.

Participants were randomized to receive phentermine/topiramate 7.5 mg/46 mg (n=54), phentermine/topiramate 15 mg/92 mg (n=113), or placebo (n=56) once a day after a titration period. Participants also received counseling in lifestyle modifications, including reducing calories and increasing physical activity.

At the end of the study, participants on the 7.5 mg/46 mg dose lost on average 4.8% of their BMI, and those on the 15 mg/92 mg dose lost on average 7.1% of their BMI. Those who were given placebo gained 3.3% of their BMI on average.

Patients starting this drug are advised to take a pregnancy test before use, and to continuously use contraceptives during treatment, since the drug is associated with fetal harm.

Phentermine/topiramate is also not recommended for those with glaucoma, hyperthyroidism, or those who are currently taking or have taken monoamine oxidase inhibitors in the prior 2 weeks.

Common adverse events experienced by adolescents included depression, fever, flu, joint pain, dizziness, and ankle sprain, while adults often experience dizziness, dry mouth, constipation, a pins-and-needles sensation, altered sense of taste, and insomnia. The drug has also been associated with increased heart rate and suicidal ideation.

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