作者：Hollander PA, Elbein SC, Hirsch IB, Kelley D, McGill J, Taylor T, Weiss SR, Crockett SE, Kaplan RA, Comstock J, Lucas CP, Lodewick PA, Canovatchel W, Chung J, Hauptman J.
作者单位：美国德克萨斯州达拉斯贝勒医疗中心。
【摘自】美国糖尿病护理杂志，1998年8月第21刊第8期。
【摘要】
目的：肥胖对于2型糖尿病来说是一个重要的风险因子，伴2型糖尿病的肥胖患者的减肥与改善血糖控制和减少心血管疾病风险因子相关，但是减肥尤其很难以限制卡路里和锻炼去维持。这项研究的目的是为了发现奥利司他(脂肪酶抑制剂)在伴2型糖尿病肥胖患者中减重、血糖控制和血脂水平的影响。
研究设计与方法：在一项57周的多中心随机双盲安慰剂对照研究中，391名BMI在28~40范围内、且年龄≥18岁的伴Ⅱ型糖尿病的男女，1日3次口服奥利司他120mg或安慰剂，并伴随中度低热量饮食，同时临床上口服磺酰脲类的稳定群体。测量其体重变化，血糖控制，血脂水平和药物耐受性。
结果：经过1年的治疗，奥利司他组较初始体重减少了6.2±0.45%，安慰剂组较初始体重减少了4.3±0.49%，且在奥利司他组中，体重减少≥5%的人数比减少≤5%的人数多两倍。两组中，奥利司他组和安慰机组均能显著提升血糖控制能力，反映在糖化血红蛋白、空腹血糖水平降低，磺酰脲类口服降糖药剂量下降。与安慰剂组相比，奥利司他组能够显著改善脂质水平，即显著的降低总胆固醇、低密度脂蛋白、三酰甘油、载脂蛋白B。在奥利司他治疗过程中，曾经报告过中轻度和暂时的胃肠道反应，尽管他们的协会有着极低的撤回率。脂溶性维生素水平总体上仍处于参考范围内，仅少数病人需要服用维生素补充剂。
结论：服用奥利司他对伴Ⅱ型糖尿病肥胖患者是一种有效的治疗方式，奥利司他能够显著降低并长期维持患者体重，提高患者血糖控制水平，改善患者的血脂代谢。
文献原文：
Role of Orlistat in the Treatment of Obese Patients With Type 2 Diabetes: A 1-year randomized double-blind study
Author：Hollander PA, Elbein SC, Hirsch IB, Kelley D, McGill J, Taylor T, Weiss SR, Crockett SE, Kaplan RA, Comstock J, Lucas CP, Lodewick PA, Canovatchel W, Chung J, Hauptman J.
Author information：Baylor Medical Center,Dallas,Texas,USA.
Quote：Diabetes Care. 1998 Aug;21(8):1288-94
【ABSTRACT】
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/m2, 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 ≥ 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 HbA1c (P < 0.001) and fasting 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.
文献详情：http://www.ncbi.nlm.nih.gov/pubmed/9702435/