Phentermine/topiramate for obesity in adolescents (mid-dose)
Trial question
What is the role of mid-dose phentermine/topiramate in adolescents with obesity?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
53.0% female
47.0% male
N = 110
110 patients (58 female, 52 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=54 mid-dose phentermine/topiramate (7.5 mg phentermine and 46 mg topiramate oral capsule once daily).
N=56 placebo (matching placebo oral capsule).
Primary outcome
Reduction in body mass index at week 56
4.78%
-3.34%
4.8 %
3.6 %
2.4 %
1.2 %
0.0 %
-1.2 %
-2.4 %
-3.6 %
Mid-dose
phentermine/topiramate
Placebo
Significant
increase ▲
NNT = 12
Significantly greater reduction in BMI at week 56 (4.78% vs. -3.34%; AD 8.11%, 95% CI 4.31 to 11.92).
Secondary outcomes
Significantly greater reduction in waist circumference (7.42 cm vs. -0.31 cm; AD 7.72 cm, 95% CI 4.02 to 11.43).
Significantly greater improvement in HDL-C (6.65% vs. -3.65%; AD 10.3%, 95% CI 2.91 to 17.7).
Significantly greater reduction in triglycerides (12.79% vs. -8.35%; AD 21.14%, 95% CI 2.05 to 40.24).
Safety outcomes
No significant difference in any adverse event.
Conclusion
In adolescents with obesity, mid-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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