The effects of orlistat on body weight and glycaemic control in overweight patients with type 2 diabetes: a randomized, placebo-controlled trial
The effects of orlistat on body weight and glycaemic control in overweight patients with type 2 diabetes: a randomized, placebo-controlled trial
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DOI：
10.1046/j.1463-1326.2002.00237.x
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发表时间：
2002-11-01
影响因子：
5.8
通讯作者：
Sachse, G
中科院分区：
文献类型：
--
作者：
Hanefeld, M;Sachse, G
目的：评估奥利司他对超重2型糖尿病患者体重、血糖控制和心血管危险因素的长期影响。方法：这是一项多中心、随机、安慰剂对照研究，包括4周安慰剂加饮食导入期和48周双盲治疗期。超重或肥胖成人[体重指数（BMI）大于或等于28 kg/m2]，HbA（1c）为6.5-11%，临床2型糖尿病患者随机接受奥利司他（120 mg，每日3次）治疗。n = 189）或安慰剂（n = 180）联合低热量饮食。患者在研究前接受磺脲类药物治疗至少2个月，或未接受任何抗糖尿病药物治疗（其中大多数是药物初治）。结果：1年后，奥利司他组患者的体重减轻明显多于安慰剂组患者（-5.4% vs. -3.6%; p = 0.006）。此外，奥利司他组体重减轻≥ 5%的患者显著多于安慰剂组（51.3% vs.31.6%; p = 0.0001）。奥利司他治疗的患者在HbA（1c）（-0.9% vs. -0.4%; p < 0.001）、空腹血糖（-1.6 vs. -0.7 mmol/l; p = 0.004）和餐后血糖（-1.8 vs. -0.5 mmol/l; p = 0.003）方面的改善也显著大于安慰剂治疗的患者。此外，与安慰剂相比，奥利司他治疗的患者LDL胆固醇降低程度显著更大。总体而言，奥利司他与安慰剂具有相似的安全性特征，除了已知与奥利司他的作用方式相关的一般轻度和短暂性胃肠道事件的发生率较高。结论：奥利司他加饮食治疗可显着减轻体重，改善血糖控制和超重2型糖尿病患者的心血管危险因素特征。
Aim: To assess the long-term effects of orlistat on body weight, glycaemic control and cardiovascular risk factors in overweight patients with type 2 diabetes.Methods: This was a multicentre, randomized, placebo-controlled study with a 4-week placebo plus diet lead-in period and a 48-week, double-blind treatment period. Overweight or obese adults [body mass index (BMI) greater than or equal to 28 kg/m(2)] with HbA(1c), of 6.5-11% and clinical type 2 diabetes were randomized to orlistat (120 mg t.i.d. n = 189) or placebo (n = 180) in conjunction with a low-calorie diet. Patients had either received sulphonylurea therapy for at least 2 months before the study or were not receiving any antidiabetic medication (the majority of which were drug-naive).Results: After 1 year, patients in the orlistat group lost significantly more weight than patients in the placebo group (-5.4% vs. -3.6%; p = 0.006). Moreover, significantly more patients achieved weight loss of greater than or equal to5% with orlistat compared with placebo (51.3% vs. 31.6%; p = 0.0001). Patients treated with orlistat also had significantly greater improvements than placebo-treated patients in HbA(1c), (-0.9% vs. -0.4%; p < 0.001), fasting glucose (-1.6 vs. -0.7 mmol/l; p = 0.004) and post-prandial glucose (-1.8 vs. -0.5 mmol/l; p = 0.003). In addition, orlistat-treated patients had a significantly greater reduction in LDL cholesterol compared with placebo. Overall, orlistat had a similar safety profile to placebo, with the exception of a higher incidence of generally mild and transient gastrointestinal events known to be associated with the mode of action of orlistat.Conclusions: Treatment with orlistat plus diet resulted in significant weight loss, improved glycaemic control and cardiovascular risk factor profile in overweight patients with type 2 diabetes.