Hong Sangmo, Kim Won Jun, Kang Eun Seok, Jeong In-Kyung, Kim Chong Hwa, Lee Ki Young, Kim Sungrae, Oh Seung Joon, Lee Chang Beom
Department of Internal Medicine, Guri Hospital, Hanyang University, College of Medicine, Seoul, Republic of Korea.
Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Republic of Korea.
Diabetes Obes Metab. 2025 Mar;27(3):1242-1250. doi: 10.1111/dom.16119. Epub 2024 Dec 20.
This study evaluated the efficacy and safety of a combination of phentermine and delayed-release topiramate (PHEN/TPM CR) versus placebo as an adjunct to standard lifestyle recommendations in Korean adults.
This 56-week, randomized, double-blind, placebo-controlled, phase 4 trial enrolled adults (age 19-70 years) with obesity (BMI ≥ 25 kg/m) at eight sites in South Korea. After a 12-week lifestyle programme, participants were randomly assigned in a 1:1 ratio to receive PHEN/TPM CR or placebo. PHEN/TPM CR was commenced at 3.75 mg/23 mg daily for 14 days and increased to 7.5 mg/46 mg daily, and to 15 mg/92 mg if 3% weight loss was not achieved after 12 weeks. The primary outcomes were percentage change in body weight from baseline to Week 56.
A total of 232 participants underwent randomization. At 56 weeks, the percentage change in body weight was -8.3% with PHEN/TPM CR and -2.3% with placebo (treatment difference -6.1%; 95% confidence interval [CI], -7.7 to -4.5, p < 0.001). Participants receiving PHEN/TPM CR were more likely to achieve ≥5% weight loss compared with those receiving placebo (68.5% vs. 25.0%, odds ratio [OR], 6.4; 95% CI, 3.5 to 11.6; p < 0.001). Dizziness, paraesthesia and dry mouth were more common in the PHEN/TPM CR group, although most adverse events were mild or moderate.
Administration of PHEN/TPM CR plus lifestyle intervention in Korean adults with obesity resulted in a greater reduction in body weight and adiposity than lifestyle intervention alone.
本研究评估了在韩国成年人中，与安慰剂相比，苯丁胺和缓释托吡酯组合制剂（PHEN/TPM CR）作为标准生活方式建议辅助治疗手段的疗效和安全性。
这项为期56周的随机、双盲、安慰剂对照4期试验，在韩国8个地点招募了肥胖（体重指数≥25kg/m）的成年人（年龄19 - 70岁）。经过12周的生活方式干预计划后，参与者按1:1比例随机分配接受PHEN/TPM CR或安慰剂。PHEN/TPM CR开始剂量为每日3.75mg/23mg，持续14天，然后增加至每日7.5mg/46mg，如果12周后体重未减轻3%，则增加至15mg/92mg。主要结局指标是从基线到第56周体重的百分比变化。
共有232名参与者进行了随机分组。在第56周时，接受PHEN/TPM CR治疗的参与者体重百分比变化为 - 8.3%，接受安慰剂治疗的为 - 2.3%（治疗差异为 - 6.1%；95%置信区间[CI]，- 7.7至 - 4.5，p < 0.001）。与接受安慰剂的参与者相比，接受PHEN/TPM CR的参与者更有可能实现体重减轻≥5%（68.5%对25.0%，优势比[OR]为6.4；95%CI，3.5至11.6；p < 0.001）。头晕、感觉异常和口干在PHEN/TPM CR组中更常见，不过大多数不良事件为轻度或中度。
在韩国肥胖成年人中，给予PHEN/TPM CR加生活方式干预比单纯生活方式干预能更大程度地减轻体重和减少肥胖。
