Kwon Yu-Jin, Lee Hyangkyu, Nam Chung Mo, Chang Hyuk-Jae, Yoon Young-Ran, Lee Hye Sun, Lee Ji-Won
Department of Family Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, Republic of Korea.
Department of Medicine, Graduate School of Yonsei University College of Medicine, Seoul, Republic of Korea.
Diabetes Metab Syndr Obes. 2021 Mar 2;14:941-950. doi: 10.2147/DMSO.S300342. eCollection 2021.
In clinical practice, concomitant treatment of orlistat with phentermine is commonly used off-label. However, clinical trials have not been performed to evaluate whether their combination improves metabolic parameters and cardiovascular risk factors other than weight loss. Therefore, we aimed to compare the efficacy of concomitant administration of orlistat and phentermine versus phentermine alone on the endothelial cell function in overweight and obese adults with back pain.
We conducted a 12-week, double-blinded, placebo-controlled clinical trial involving 114 patients with a body mass index of ≥30 (obese) or ≥27 (overweight) with weight-related comorbidities. We randomly assigned patients in a 1:1 ratio to receive orlistat (120mg) three times daily and phentermine (37.5mg) once daily, or a placebo three times daily and phentermine (37.5mg) once daily. Primary endpoint was changes in endothelium-dependent vasodilatation measured using ultrasound assessment of flow-mediated dilatation (FMD). Differences within groups after intervention were compared using the paired -test or Wilcoxon signed-rank test. Differences in changes between the groups were calculated using an analysis of covariance after adjusting for each baseline value.
Mean weight loss during the 12-week study period was 6.1kg in the orlistat/phentermine group and in the placebo/phentermine group. Adjusted mean changes in total and non-high-density lipoprotein cholesterol were significantly greater in the orlistat/phentermine group than in the placebo/phentermine group. Adjusted mean changes in endothelium-dependent FMD were significantly greater in the orlistat/phentermine group than in the placebo/phentermine group (4.97±0.98% vs 2.05±0.99%, respectively; p=0.038). Changes in endothelium-independent nitroglycerin-mediated dilatation were not significantly different between the groups.
Orlistat/phentermine significantly improved the vascular endothelial cell function compared with phentermine alone. Orlistat might have beneficial effects on the decrease of the risk of cardiovascular disease, especially in overweight and obese patients with comorbidities.
ClinicalTrails.gov number, NCT03675191.
在临床实践中，奥利司他与苯丁胺联合治疗常用于非适应证用药。然而，尚未进行临床试验来评估它们的联合使用是否能改善代谢参数以及除体重减轻之外的心血管危险因素。因此，我们旨在比较奥利司他与苯丁胺联合给药和单独使用苯丁胺对伴有背痛的超重和肥胖成年人内皮细胞功能的疗效。
我们进行了一项为期12周的双盲、安慰剂对照临床试验，纳入了114名体重指数≥30（肥胖）或≥27（超重）且患有与体重相关合并症的患者。我们将患者按1:1的比例随机分配，分别接受每日三次奥利司他（120mg）和每日一次苯丁胺（37.5mg），或每日三次安慰剂和每日一次苯丁胺（37.5mg）。主要终点是使用超声评估血流介导的血管舒张（FMD）来测量内皮依赖性血管舒张的变化。干预后组内差异使用配对t检验或Wilcoxon符号秩检验进行比较。在对每个基线值进行调整后，使用协方差分析计算组间变化差异。
在12周的研究期间，奥利司他/苯丁胺组和安慰剂/苯丁胺组的平均体重减轻均为6.1kg。奥利司他/苯丁胺组总胆固醇和非高密度脂蛋白胆固醇的调整后平均变化显著大于安慰剂/苯丁胺组。奥利司他/苯丁胺组内皮依赖性FMD的调整后平均变化显著大于安慰剂/苯丁胺组（分别为4.97±0.98%和2.05±0.99%；p = 0.038）。两组间非内皮依赖性硝酸甘油介导的血管舒张变化无显著差异。
与单独使用苯丁胺相比，奥利司他/苯丁胺显著改善了血管内皮细胞功能。奥利司他可能对降低心血管疾病风险具有有益作用，尤其是在患有合并症的超重和肥胖患者中。
ClinicalTrails.gov编号，NCT03675191。
