Bensignor Megan O, Freese Rebecca L, Rudser Kyle D, Kelly Aaron S, Kunin-Batson Alicia, Gross Amy C, Bramante Carolyn, Shih Winnie, Peterson Craig, Fox Claudia K
Department of Pediatrics, Medical School, University of Minnesota, Minneapolis, MN, USA.
Center for Pediatric Obesity Medicine, University of Minnesota Medical School, Minneapolis, MN, USA.
Int J Obes (Lond). 2025 Jun 15. doi: 10.1038/s41366-025-01821-6.
BACKGROUND/OBJECTIVES: Obesity treatment can produce variable outcomes for different individuals. The aim of this analysis in adolescents with obesity was to investigate if baseline participant characteristics associated with BMI reduction from baseline to 56 weeks when treated with mid- or top-dose phentermine/topiramate (PHEN/TPM) compared to placebo.
A secondary analysis of a randomized, double-blind, placebo-controlled, clinical trial evaluating PHEN/TPM in adolescents with obesity was conducted. Participants, aged 12 to <17 years with a BMI ≥95th percentile, were randomly assigned in a 1:1:2 ratio to receive either placebo, mid-dose (PHEN/TPM 7.5 mg/46 mg) or top-dose (PHEN/TPM 15 mg/92 mg). Baseline characteristics included in the analysis were BMI, age, sex, race/ethnicity, pubertal status, diabetes status, depression status, cognitive function score, and quality of life score. The primary analysis used linear regression with BMI percent change from baseline to 56 weeks as the outcome with either mid- or top-dose PHEN/TPM compared to placebo.
Two-hundred twenty-two participants were included in the final analysis. None of the baseline characteristics were statistically significantly associated with BMI reduction with mid- or top-dose PHEN/TPM compared to placebo.
Baseline characteristics were not predictive of BMI reduction with either dose of PHEN/TPM compared to placebo in adolescents with obesity.
背景/目的：肥胖治疗对不同个体可能产生不同的结果。本分析针对肥胖青少年的目的是，研究与接受中剂量或高剂量苯丁胺/托吡酯（PHEN/TPM）治疗相比，接受安慰剂治疗时，从基线到56周体重指数（BMI）降低相关的基线参与者特征。
对一项评估PHEN/TPM用于肥胖青少年的随机、双盲、安慰剂对照临床试验进行了二次分析。年龄在12至<17岁、BMI≥第95百分位数的参与者按1:1:2的比例随机分配，分别接受安慰剂、中剂量（PHEN/TPM 7.5mg/46mg）或高剂量（PHEN/TPM 15mg/92mg）治疗。分析中纳入的基线特征包括BMI、年龄、性别、种族/族裔、青春期状态、糖尿病状态、抑郁状态、认知功能评分和生活质量评分。主要分析采用线性回归，以从基线到56周的BMI百分比变化作为结果，比较中剂量或高剂量PHEN/TPM与安慰剂。
222名参与者纳入最终分析。与安慰剂相比，中剂量或高剂量PHEN/TPM治疗时，没有一项基线特征与BMI降低存在统计学显著关联。
与安慰剂相比，在肥胖青少年中，基线特征不能预测任何一种剂量的PHEN/TPM治疗导致的BMI降低。
