Effects of Orlistat/Phentermine versus Phentermine on Vascular Endothelial Cell Function in Obese and Overweight Adults: A Randomized, Double-Blinded, Placebo-Controlled Trial

Yu-Jin Kwon,1– 3 Hyangkyu Lee,4 Chung Mo Nam,5 Hyuk-Jae Chang,6 Young-Ran Yoon,7 Hye Sun Lee,8 Ji-Won Lee1 1Department of Family Medicine, Yonsei University College of Medicine, Severance Hospital, Seoul, Republic of Korea; 2Department of Medicine, Graduate School of Yonsei University College of Medicine, Seoul, Republic of Korea; 3Department of Family Medicine, Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, Republic of Korea; 4 Yonsei University College of Nursing, Mo-Im Kim Nursing Research Institute, Seoul, Republic of Korea; 5Department of Preventive Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea; 6Department of Internal Medicine, Division of Cardiology, Severance Cardiovascular Hosp, Yonsei University College of Medicine, Seoul, Republic of Korea; 7Department of Molecular Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea; 8Biostatistics Collaboration Unit, Department of Research Affairs, Yonsei University College of Medicine, Seoul, Republic of KoreaCorrespondence: Ji-Won LeeDepartment of Family Medicine, Yonsei University College of Medicine, Gangnam Severance Hospital, 211 Eonju‐ro, Gangnam‐gu, 06273, Seoul, 135-720, Republic of KoreaTel +82 2 2019 3480Fax +82 3462 8209Email indi5645@yuhs.acBackground: 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.Methods: 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 we