Multicentre, placebo-controlled trial of lorcaserin for weight management in Chinese population
Multicentre, placebo-controlled trial of lorcaserin for weight management in Chinese population
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DOI：
10.1016/j.orcp.2018.07.007
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发表时间：
2018-09-01
影响因子：
4.3
通讯作者：
Huang, Kuo-Chin
中科院分区：
文献类型：
--
作者：
Lu, Chia-Wen;Chang, Chih-Jen;Huang, Kuo-Chin
目的：本研究旨在评估氯卡色林对肥胖患者体重、心血管危险因素和安全性的影响。方法：在这项双盲、随机对照试验中，171名肥胖成年人被分配接受氯卡色林10 mg或安慰剂，每天两次，持续24周。在整个治疗期间，对所有患者进行饮食和运动咨询。主要结局是体重至少减轻5%和10%的患者比例以及体重的平均变化。安全性和耐受性终点，如贝克抑郁量表-II，血液生化，生命体征和心电图进行了监测。（52.4%和28.1%，P=0.001），平均体重减轻5.8 kg（95% CI：-6.91，-4.70）与安慰剂组3.6 kg（95% CI：-4.95，-2.33）比较，差异有统计学意义（P< 0.05）。氯卡色林组中发生率较高的最常见不良反应是自限性头晕。严重的不良反应是罕见的，并报告了更多的患者服用安慰剂比lorcaserin.Conclusions：在这个多中心，双盲安慰剂对照试验，lorcaserin是有效的，耐受性良好，在亚洲组。(C)2018亚洲大洋洲肥胖研究协会。由爱思唯尔有限公司出版。保留所有权利。
Objective: This study aimed to evaluate the effects of lorcaserin on body weight, cardiovascular risk factors, and safety in obese patients in Taiwan.Methods: In this double-blind, randomised controlled trial, 171 obese adults were assigned to receive lorcaserin at a dose of 10 mg, or placebo, twice a day for 24 weeks. Diet and exercise counselling were given to all patients through the treatment period. Primary outcomes were proportion of patients achieving at least 5% and 10% reduction in body weight and mean change in body weight. Safety and tolerability endpoints such as Beck Depression Inventory-II, blood biochemistry, vital signs, and electrocardiogram were monitored.Results: More patients receiving lorcaserin lost at least 5% body weight than receiving placebo (52.4% and 28.1%, P=0.001) with an average weight reduction of 5.8 kg (95% CI: -6.91, -4.70) in lorcaserin group and those of 3.6 kg (95% CI: -4.95, -2.33) in placebo group (P< 0.05). The most common adverse effect with greater incidence in the lorcaserin group was self-limited dizziness. Serious adverse effect were rare and was reported by slightly more patients taking placebo than lorcaserin.Conclusions: In this multicentre, double-blinded placebo-controlled trial, lorcaserin was effective and well-tolerable in Asia group. (C) 2018 Asia Oceania Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.