作者：Muls E, Kolanowski J, Scheen A, Van Gaal L; ObelHyx Study Group.
【摘自】国际肥胖期刊杂志，2001年11月第25刊第11期。
【摘要】
目的：评价奥利司他组120毫克每日三次和安慰剂组对减重和肥胖兼高脂血症患者血脂的影响。
设计：24周的多中心，随机，双盲，安慰剂对照试验。经过一个为期两周的单盲洗脱期（安慰剂+饮食（-600大卡/天；脂肪≤30%）），294例患者采取低热量饮食并随机分为奥利司他120毫克组或安慰剂组，每日三次。完成双盲研究的患者（n = 255），在随后的24周开放标签参与奥利司他扩展阶段实验。研究对象：体重指数（BMI）27–40 kg /m 2，高脂血症（LDL-C： 4.1–6.7 mmol/L）。
评价标准：疗效评估包括减重，血脂水平，心血管危险因素和体脂参数；安全评估。
结果：在洗脱期两组的减重效果没有差别。随机分组后，奥利司他组患者比安慰剂组减重更明显：从洗脱期到24周，体重变化百分比奥利司他组- 6.8%，安慰剂-3.8%（P＜0.001）。此外，24周后，奥利司他组和安慰剂组达到临床上减重5%以上的人数（64 vs 39%），10%以上的人数（23 vs 13%）。奥利司他治疗组总胆固醇（-11.9 vs -4%；P＜0.001）和低密度脂蛋白 （-17.6 vs -7.6%；P＜0.001）改善更明显。在双盲实验期间，LDL-C的改善奥利司他治疗组比安慰剂组更为明显，这表明奥利司他除了减重之外还有直接的降低胆固醇的作用（P＜0.001）。开始服用安慰剂患者改用奥利司他后在体重，总胆固醇和LDL-C的降低上更明显。与安慰剂组相比，奥利司他组安全性和耐受性都比较好，但胃肠道事件发生率稍高（64 vs 38%）。结论：服用奥利司他并适当的饮食干预可以对超重或肥胖兼高脂血症患者达到明显的降低体重和LDL-C的效果。
[关键词] 肥胖；奥利司他；脂肪酶抑制；血脂；心血管危险因素
文献原文：
The effects of orlistat on weight and on serum lipids in obese patients with hypercholesterolemia: a randomized,double-blind, placebo-controlled, multicentre study.
Author：Muls E, Kolanowski J, Scheen A, VanGaal L; ObelHyx Study Group.
Author information：Department of Endocrinology, Metabolism and Nutrition, University Hospital, Gasthuisberg, Leuven, Belgium.
Quote：International Journal of Obesity,2001 Nov;25(11):1713-21
【ABSTRACT】
OBJECTIVE
Assessment of the effects of orlistat 120 mg three times daily vs placebo on weight loss and serum lipids in obesehypercholesterolemic patients.
DESIGN:
A 24 week multicentre, double-blind, randomized, placebo-controlled trial. After a 2-week single-blind run-in period (placebo+diet (-600 kcal/day; < or =30% of calories as fat)), 294 patients were submitted to the hypocaloric diet and randomly assigned to either orlistat 120 mg or placebo three times daily. Patients who completed the double-blind study (n=255) were eligible for participation in a subsequent 24 week open-labelorlistat extension phase.
SUBJECTS:
Patients with body mass index (BMI) 27-40 kg/m2 and hypercholesterolemia (low-density-lipoprotein cholesterol, LDL-C, 4.1-6.7 mmol/l).
MEASUREMENTS:
Efficacy assessments included weight loss, lipid levels, other cardiovascular risk factors and anthropometric parameters. Safety assessments.
RESULTS:
Weight loss during run-in was similar in both groups. After randomization, orlistat-treated patients lost significantly more weight than placebo recipients: mean percentage weight loss from start of run-in to week 24 was-6.8% in the orlistat group and -3.8% in the placebo group (P<0.001). Moreover, more patients in the orlistat group than in the placebo group achieved clinically meaningful weight loss of > or =5% (64 vs 39%) or > or =10% (23 vs 13%) at week 24. Treatment with orlistat was associated with significantly greater changes in total cholesterol (-11.9% vs -4.0%; P<0.001) and LDL-C (-17.6 vs -7.6%; P<0.001). For any category of weight loss during the double-blind treatment period, change in LDL-C was more pronounced in orlistat-treated patients than in placebo recipients, indicating that orlistat had a direct cholesterol-lowering effect that was independent of weight reduction (P<0.001). Adjunction of orlistat during the extension phase in patients who initially received placebo induced a further decrease inweight, total cholesterol and LDL-C. Orlistat was generally well tolerated with a safety profile comparable to placebo, with the exception of a higher incidence of gastrointestinal events (> or =1 event in 64 vs 38% of patients).
CONCLUSION:
Orlistat as an adjunct to dietary intervention promotes weight loss and reduces LDL-C beyond the effect of weight loss in overweight or obese patients with concomitant hypercholesterolemia.