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Almost 20% of U.S. adolescents meet the definition for obesity. Nonsurgical interventions have limited effectiveness for obesity management in this population. Combination phentermine/topiramate is effective for treating adults with obesity, but it is not currently U.S. FDA–approved for this indication in adolescents, and whether it is safe and effective in adolescents is uncertain.
In this manufacturer-sponsored study, investigators randomized 227 otherwise healthy adolescents with obesity (age range, 12–16; mean body-mass index [BMI], 37.8 kg/m2) to placebo, medium-dose phentermine/topiramate (7.5 mg/46 mg), or high-dose phentermine/topiramate (15 mg/92 mg) for 1 year; all participants received an intensive lifestyle-intervention program. …