奥利司他治疗新诊断的中国超重或肥胖2型糖尿病患者

Orlistat in the treatment of overweight or obese Chinese patients with newly diagnosed Type 2 diabetes.

作者信息

Shi Y-F, Pan C-Y, Hill J, Gao Y

机构信息

Department of Endocrinology, Peking Union Medical College Hospital, Beijing, China.

出版信息

Diabet Med. 2005 Dec;22(12):1737-43. doi: 10.1111/j.1464-5491.2005.01723.x.

DOI:10.1111/j.1464-5491.2005.01723.x

PMID:16401321

Abstract

AIMS

Orlistat promotes weight loss in overweight and obese patients with Type 2 diabetes receiving hypoglycaemic treatment, but has not been investigated in patients with newly diagnosed and previously untreated Type 2 diabetes. We evaluated the efficacy of 24 weeks' treatment with orlistat, combined with a mildly reduced-calorie diet, on weight loss and glycaemic control in overweight and obese patients with newly diagnosed and previously untreated Type 2 diabetes.

METHODS

A total of 249 Chinese patients (body mass index 25-40 kg/m2) with recently diagnosed Type 2 diabetes were randomized to placebo (n=124) or orlistat 120 mg (n=125) three times daily; all patients followed a mildly reduced-calorie diet. Patients had HbA1c 6.5-8.5% (mean 7.3%) and had never received any glucose-lowering medication.

RESULTS

Orlistat-treated patients achieved significantly greater weight loss at the study end than placebo-treated patients (-5.4 vs. -2.4 kg; P<0.0001). More orlistat than placebo patients lost>or=5% (60.5 vs. 26.8%; P<0.0001) and >or=10% of their body weight (20.2 vs. 4.9%; P=0.0002). A significantly greater decrease in HbA(1c) from baseline was obtained with orlistat than placebo (-1.0 vs. -0.6%; P=0.0008). Orlistat-treated patients achieved a significantly greater decrease in fasting plasma glucose (-1.3 vs. -0.5 mmol/l; P=0.0003) and in the 2-h oral glucose tolerance test (-4.1 vs. -1.4 mmol/l; P<0.0001) than placebo recipients. Also, more orlistat- than placebo-treated patients improved from diabetic status to normal or impaired glucose tolerance (44.3 vs. 32.5%; P=0.0763) after 24 weeks. Orlistat also produced improvements in lipid profiles and waist circumference.

CONCLUSIONS

In combination with a mildly reduced-calorie diet, orlistat significantly reduces body weight, and improves glycaemic control and several cardiovascular risk factors in overweight and obese Chinese patients with newly diagnosed Type 2 diabetes.

摘要

目的

奥利司他可促进接受降糖治疗的超重和肥胖2型糖尿病患者体重减轻，但尚未在新诊断且未经治疗的2型糖尿病患者中进行研究。我们评估了奥利司他联合轻度低热量饮食治疗24周对新诊断且未经治疗的超重和肥胖2型糖尿病患者体重减轻及血糖控制的疗效。

方法

总共249例新诊断的2型糖尿病中国患者（体重指数25 - 40kg/m²）被随机分为安慰剂组（n = 124）或奥利司他120mg组（n = 125），每日三次；所有患者均遵循轻度低热量饮食。患者糖化血红蛋白水平为6.5 - 8.5%（平均7.3%），且从未接受过任何降糖药物治疗。

结果

在研究结束时，奥利司他治疗的患者体重减轻明显大于安慰剂治疗的患者（-5.4 vs. -2.4kg；P < 0.0001）。与安慰剂组相比，更多接受奥利司他治疗的患者体重减轻≥5%（60.5% vs. 26.8%；P < 0.0001）及≥10%（20.2% vs. 4.9%；P = 0.0002）。与安慰剂相比，奥利司他治疗使糖化血红蛋白（HbA1c）从基线水平的下降幅度显著更大（-1.0 vs. -0.6%；P = 0.0008）。奥利司他治疗的患者空腹血糖下降幅度显著大于安慰剂组（-1.3 vs. -0.5mmol/l；P = 0.0003），2小时口服葡萄糖耐量试验下降幅度也更大（-4.1 vs. -1.4mmol/l；P < 0.0001）。此外，24周后，与安慰剂治疗的患者相比，更多接受奥利司他治疗的患者从糖尿病状态改善为正常或糖耐量受损（44.