Phentermine/Topiramate for the Treatment of Adolescent Obesity.
Phentermine/Topiramate for the Treatment of Adolescent Obesity.
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DOI：
10.1056/evidoa2200014
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发表时间：
2022-06-01
期刊：
影响因子：
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通讯作者：
Varghese, Santosh T
中科院分区：
文献类型：
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作者：
Kelly, Aaron S;Bensignor, Megan O;Varghese, Santosh T
背景：抗肥胖药物可能对儿童肥胖症的治疗有用，但安全有效的选择很少。我们评估芬特明/托吡酯（PHEN/TPM）的体重管理在青少年obesity.METHODS：这56周，随机，双盲试验纳入青少年12至小于17岁的肥胖。参与者被随机分配1：1：2分别接受安慰剂（n=56），中剂量PHEN/TPM（7.5 mg/46 mg; n=54）或最高剂量PHEN/TPM（15 mg/92 mg; n=113）。所有参与者都接受了生活方式治疗。主要终点是从随机分组到第56周体重指数（BMI）的平均百分比变化。结果：参与者的平均（±SD）年龄为14.0±1.4岁，平均（±SD）BMI为37.8±7.1 kg/m2; 54.3%为女性。第56周时BMI百分比变化的主要终点显示与安慰剂组的差异为-10.44个百分点（95%CI，-13.89至-6.99; P
BACKGROUND: Antiobesity medication may be useful for the treatment of pediatric obesity, yet few safe and effective options exist. We evaluated phentermine/topiramate (PHEN/TPM) for weight management in adolescents with obesity.METHODS: This 56-week, randomized, double-blind trial enrolled adolescents 12 to less than 17 years of age with obesity. Participants were randomly assigned 1:1:2 to receive either placebo (n=56), mid-dose PHEN/TPM (7.5 mg/46 mg; n=54), or top-dose PHEN/TPM (15 mg/92 mg; n=113), respectively. All participants received lifestyle therapy. The primary end point was mean percent change in body-mass index (BMI) from randomization to week 56.RESULTS: Participants had a mean (±SD) age of 14.0±1.4 years and a mean (±SD) BMI of 37.8±7.1 kg/m2; 54.3% were female. The primary end point of percent change in BMI at week 56 showed differences from placebo of -10.44 percentage points (95% CI, -13.89 to -6.99; P