Role of orlistat in the treatment of obese patients with type 2 diabetes - A 1-year randomized double-blind study
Role of orlistat in the treatment of obese patients with type 2 diabetes - A 1-year randomized double-blind study
复制标题
DOI：
10.2337/diacare.21.8.1288
复制
发表时间：
1998-08-01
期刊：
影响因子：
16.2
通讯作者：
Hauptman, J
中科院分区：
文献类型：
--
作者：
Hollander, PA;Elbein, SC;Hauptman, J
肥胖是2型糖尿病的一个重要危险因素. 2型糖尿病患者的体重减轻与血糖控制改善和心血管疾病风险因素减少有关，但体重减轻很难通过热量限制和运动来实现和维持。本研究的目的是评估奥利司他（一种胰脂肪酶抑制剂）治疗对磺脲类药物治疗的肥胖2型糖尿病患者的体重减轻、血糖控制和血脂水平的影响。对391名年龄>18岁、BMI为28-40 kg/m2的2型糖尿病肥胖男性和女性患者口服120 mg奥利司他或安慰剂，每日3次，轻度低热量饮食，口服磺脲类药物后临床稳定。结果：治疗1年后，奥利司他组的初始体重下降了6.2 +/- 0.45%（平均值+/- SEM），而安慰剂组为4.3 +/- 0.49%（P < 0.001）。接受奥利司他治疗的患者（49 vs. 23%）体重减轻大于或等于初始体重的5%（P < 0.001）。与安慰剂加饮食相比，奥利司他加饮食治疗与血糖控制的显著改善相关，反映在HbA 1c（P < 0.001）和持续血糖（P < 0.001）的降低以及口服磺脲类药物剂量的减少（P < 0.01）。与安慰剂相比，奥利司他治疗还显著改善了几个血脂参数，即总胆固醇（P <0.001）、LDL胆固醇（P <0.001）、甘油三酯（P < 0.05）、载脂蛋白B（P < 0.001）和LDL与HDL胆固醇比值（P < 0.001）的降低幅度更大。奥利司他治疗报告了轻度至中度和短暂的胃肠道事件，尽管它们与研究退出的相关性较低。脂溶性维生素水平通常保持在参考范围内，只有少数患者需要补充维生素。结论-奥利司他是肥胖2型糖尿病患者在临床上有意义的体重减轻和维持体重减轻方面的有效治疗方式，改善血糖控制和改善血脂。
OBJECTIVE - Obesity is an important risk factor for type 2 diabetes. Weight loss in patients with type 2 diabetes is associated with improved glycemic control and reduced cardiovascular disease risk factors, but weight loss is notably difficult to achieve and sustain with caloric restriction and exercise. The purpose of this study was to assess the impact of treatment with orlistat, a pancreatic lipase inhibitor, on weight loss, glycemic control, and serum lipid levels in obese patients with type 2 diabetes on sulfonylurea medications.RESEARCH DESIGN AND METHODS - In a multicenter 57-week randomized double-blind placebo-controlled study, 120 mg orlistat or placebo was administered orally three times a day with a mildly hypocaloric diet to 391 obese men and women with type 2 diabetes who were aged >18 years, had a BMI of 28-40 kg/m(2), and were clinically stable on oral sulfonylureas. Changes in body weight, glycemic control, lipid levels, and drug tolerability were measured.RESULTS - After 1 year of treatment, the orlistat group lost 6.2 +/- 0.45% (mean +/- SEM) of initial body weight vs. 4.3 +/- 0.49% in the placebo group (P < 0.001). Twice as many patients receiving orlistat (49 vs. 23%) lost greater than or equal to 5% of initial body weight (P < 0.001). Orlistat treatment plus diet compared with placebo plus diet was associated with significant improvement in glycemic control, as reflected in decreases in HbA(1c) (P < 0.001) and lasting plasma glucose (P < 0.001) and in dosage reductions of oral sulfonylurea medication (P < 0.01). Orlistat therapy also resulted in significantly greater improvements than placebo in several lipid parameters, namely, greater reductions in total cholesterol, (P ( 0.001), LDL cholesterol (P < 0.001), triglycerides (P < 0.05), apolipoprotein B (P < 0.001), and the LDL-to-HDL cholesterol ratio (P < 0.001). Mild to moderate and transient gastrointestinal events were reported with orlistat therapy, although their association with study withdrawal was low Fat-soluble vitamin levels generally remained within the reference range, and vitamin supplementation was required in only a few patients.CONCLUSIONS - Orlistat is an effective treatment modality in obese patients with type 2 diabetes with respect to clinically meaningful weight loss and maintenance of weight loss, improved glycemic control, and improved lipid profile.