Department of Endocrinology and Metabolism, Hallym University School of Medicine, Hallym University Sacred Heart Hospital, Anyang, Korea.
Diabetes Obes Metab. 2010 Oct;12(10):876-82. doi: 10.1111/j.1463-1326.2010.01242.x.
To evaluate the efficacy and safety of a newly developed formulation of phentermine diffuse-controlled release (DCR) in patients with obesity.
This was a randomized, double-blind, placebo-controlled trial of 12 weeks of treatment with phentermine DCR 30 mg (n = 37) or placebo (n = 37), administered once daily in patients with obesity with controlled diabetes, hypertension or dyslipidaemia. The efficacy was evaluated by changes in body weight and waist circumference from baseline at 12 weeks and also changes in metabolic parameters, including lipid profiles and blood pressure.
The participants in the phentermine DCR group showed significant reductions in body weight (-8.1 ± 3.9 vs. -1.7 ± 2.9 kg, p < 0.001) and waist circumference (7.2 ± 0.5 vs. 2.1 ± 0.6 cm, p < 0.001) compared with those in the placebo group. Weight reductions of 5% or greater from the baseline (95.8 vs. 20.8%, p < 0.001) and 10% or more (62.5 vs. 4.7%, p < 0.001) were achieved in the DCR phentermine group and placebo group, respectively. Total cholesterol and low-density lipoprotein cholesterol (LDL-C) levels were significantly improved in the phentermine DCR group. However, there were no significant differences in systolic and diastolic blood pressure between the groups. Dry mouth and insomnia were the most common adverse events, but these were mild to moderate and transient.
Short-term phentermine DCR treatment resulted in significant reduction in weight and improvement of metabolic parameters, including waist circumference and some lipid profiles, without clinically severe adverse events. Further study is needed to show long-term efficacy and safety of phentermine DCR in Korean patients with obesity.
评估新开发的苯丁胺扩散控制释放（DCR）制剂在肥胖患者中的疗效和安全性。
这是一项为期 12 周的随机、双盲、安慰剂对照试验，共纳入 37 例接受苯丁胺 DCR 30mg 或安慰剂治疗的肥胖合并糖尿病、高血压或血脂异常控制良好的患者。疗效评估指标为 12 周时体重和腰围较基线的变化，以及血脂谱和血压等代谢参数的变化。
与安慰剂组相比，苯丁胺 DCR 组的体重（-8.1 ± 3.9 与-1.7 ± 2.9kg，p < 0.001）和腰围（7.2 ± 0.5 与 2.1 ± 0.6cm，p < 0.001）明显降低。体重减轻 5%或更多（95.8%与 20.8%，p < 0.001）和 10%或更多（62.5%与 4.7%，p < 0.001）的患者比例，在 DCR 苯丁胺组和安慰剂组中分别达到了 95.8%和 20.8%。苯丁胺 DCR 组总胆固醇和低密度脂蛋白胆固醇（LDL-C）水平显著改善。然而，两组之间的收缩压和舒张压没有显著差异。口干和失眠是最常见的不良反应，但均为轻度至中度和一过性。
短期苯丁胺 DCR 治疗可显著减轻体重，改善代谢参数，包括腰围和部分血脂谱，且无临床严重不良事件。需要进一步研究以评估苯丁胺 DCR 在韩国肥胖患者中的长期疗效和安全性。
