Phentermine/topiramate for obesity in adolescents (top-dose)
Trial question
What is the role of top-dose phentermine/topiramate in adolescents with obesity?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
55.0% female
45.0% male
N = 169
169 patients (93 female, 76 male).
Inclusion criteria: adolescents with obesity.
Key exclusion criteria: treatment with antiobesity medications; history of bariatric surgery or eating disorders; stimulant use; T1DM; congenital heart disease; obesity of a known genetic or endocrine origin.
Interventions
N=113 top-dose phentermine/topiramate (15 mg phentermine and 92 mg topiramate oral capsule once daily).
N=56 placebo (matching placebo oral capsule).
Primary outcome
Reduction in body mass index at week 56
7.11%
-3.34%
7.1 %
5.3 %
3.6 %
1.8 %
0.0 %
-1.8 %
-3.6 %
Top-dose
phentermine/topiramate
Placebo
Significant
increase ▲
NNT = 9
Significantly greater reduction in BMI at week 56 (7.11% vs. -3.34%; AD 10.44%, 95% CI 6.99 to 13.89).
Secondary outcomes
Significantly greater reduction in waist circumference (9.27 cm vs. -0.31 cm; AD 9.58 cm, 95% CI 6.33 to 12.83).
Significantly greater improvement in HDL-C (5.1% vs. -3.65%; AD 8.75%, 95% CI 2.15 to 15.35).
Significantly greater reduction in triglycerides (12.37% vs. -8.35%; AD 20.72%, 95% CI 3.72 to 37.71).
Safety outcomes
No significant difference in adverse effects.
Conclusion
In adolescents with obesity, top-dose phentermine/topiramate was superior to placebo with respect to reduction in BMI at week 56.
Reference
Aaron S Kelly, Megan O Bensignor, Daniel S Hsia et al. Phentermine / Topiramate for the Treatment of Adolescent Obesity. NEJM Evid. 2022 Jun;1(6):10.1056/evidoa2200014.
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