Metformin as an adjunctive treatment to control body weight and metabolic dysfunction during olanzapine administration:: A multicentric, double-blind, placebo-controlled trial
Metformin as an adjunctive treatment to control body weight and metabolic dysfunction during olanzapine administration:: A multicentric, double-blind, placebo-controlled trial
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DOI：
10.1016/j.schres.2007.03.029
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发表时间：
2007-07-01
影响因子：
4.5
通讯作者：
de Baptista, Enma Araujo
中科院分区：
文献类型：
--
作者：
Baptista, Trino;Rangel, Nairy;de Baptista, Enma Araujo
背景：过度体重增加（BWG）是临床相关的奥氮平副作用。本研究的主要目的是评估在奥氮平治疗下，二甲双胍是否能预防或逆转精神分裂症或双相情感障碍患者的BWG。其次，我们评估了不同的代谢变量。方法：80例服用奥氮平（5 ~ 20mg /天，连续4个月以上）的患者随机分为二甲双胍组（n = 40； 850 ~ 2550mg /天）和安慰剂组（n = 40），为期12周。在基线和治疗第12周时评估腰围（WC）、体重（BW）、体重指数（BMI）、空腹血糖、糖化血红蛋白（Hblc）、胰岛素、胰岛素抵抗指数（HOMA-IR）、瘦素、c反应蛋白、纤维蛋白原、皮质醇和生长激素（GH）。结果：二甲双胍组体重减轻1.4 +/- 3.2 kg (p = 0.01)，瘦素水平有下降趋势，而安慰剂组体重保持稳定：-0.18 +/- 2.8 kg （p = 0.7）。安慰剂组HOMA-IR显著升高（p = 0.006），二甲双胍组无变化（p = 0.8）。在其他变量中没有观察到明显的差异，即使二甲双胍没有改善血脂和Hblc水平。结论：二甲双胍可以安全地帮助奥氮平治疗的患者控制体重和碳水化合物代谢。(c) 2007 Elsevier B.V.版权所有
Background: Excessive body weight gain (BWG) is a clinically relevant side effect of olanzapine administration. The primary objective of this study was to assess whether metformin prevents or reverses BWG in patients with schizophrenia or bipolar disorder under olanzapine administration. Secondarily we evaluated diverse metabolic variables.Methods: Eighty patients taking olanzapine (5-20 mg daily for more than 4 consecutive months) were randomly allocated to metformin (n = 40; 850 to 2550 mg daily) or placebo (n = 40) group in a 12-week double-blind protocol. Waist circumference (WC) body weight (BW), body mass index (BMI) fasting glucose, glycated hemoglobin (Hblc), insulin, an insulin resistance index (HOMA-IR) lipids, leptin, c-reactive protein, fibrinogen, cortisol and the growth hormone (GH) were evaluated at baseline and at week 12 of treatment.Results: The metformin group lost 1.4 +/- 3.2 kg (p = 0.01) and tended to decrease its leptin levels, whereas the placebo group maintained a stable weight: -0.18 +/- 2.8 kg (p = 0.7). The HOMA-IR significantly increased after placebo (p = 0.006) and did not change after metformin (p = 0.8). No ostensible differences were observed in the other variables, even though metformin did not improve the lipid profile and the Hblc levels.Conclusions: Metformin may safely assist olanzapine-treated patients in body weight and carbohydrate metabolism control. (c) 2007 Elsevier B.V. All rights reserved.