Background: 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 admin-istration of orlistat and phentermine versus phentermine alone on the endothelial cell function in overweight and obese adults with back pain. Methods: We conducted a 12-week, double-blinded, placebo-controlled clinical trial invol-ving 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 t-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. Results: 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 nitrogly-cerin-mediated dilatation were not significantly different between the groups. Conclusion: 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. Trial Registration: ClinicalTrails.gov number, NCT03675191.
|Number of pages||10|
|Journal||Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy|
|Publication status||Published - 2021|
Bibliographical noteFunding Information:
This study was supported by research grants from Hanmi Pharmaceutical Co., Ltd. (J.W.L), the institute for information & communications technology promotion (IITP) grant funded by the Korea government (MSIT) (2019-31-1293, Autonomous digital companion framework and application) (H.J.C) and by a 2018 faculty research grant from Yonsei University College of Medicine [6-2018-0090] to Y.J.K. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
© 2021 Kwon et al.
All Science Journal Classification (ASJC) codes
- Internal Medicine