作者：Muls E, Kolanowski J, Scheen A, Van Gaal L; ObelHyx Study Group.
【摘自】國(guó)際肥胖期刊雜志，2001年11月第25刊第11期。
【摘要】
目的：評(píng)價(jià)奧利司他組120毫克每日三次和安慰劑組對(duì)減重和肥胖兼高脂血癥患者血脂的影響。
設(shè)計(jì)：24周的多中心，隨機(jī)，雙盲，安慰劑對(duì)照試驗(yàn)。經(jīng)過一個(gè)為期兩周的單盲洗脫期（安慰劑+飲食（-600大卡/天；脂肪≤30%）），294例患者采取低熱量飲食并隨機(jī)分為奧利司他120毫克組或安慰劑組，每日三次。完成雙盲研究的患者（n = 255），在隨后的24周開放標(biāo)簽參與奧利司他擴(kuò)展階段實(shí)驗(yàn)。研究對(duì)象：體重指數(shù)（BMI）27–40 kg /m 2，高脂血癥（LDL-C： 4.1–6.7 mmol/L）。
評(píng)價(jià)標(biāo)準(zhǔn)：療效評(píng)估包括減重，血脂水平，心血管危險(xiǎn)因素和體脂參數(shù)；安全評(píng)估。
結(jié)果：在洗脫期兩組的減重效果沒有差別。隨機(jī)分組后，奧利司他組患者比安慰劑組減重更明顯：從洗脫期到24周，體重變化百分比奧利司他組- 6.8%，安慰劑-3.8%（P＜0.001）。此外，24周后，奧利司他組和安慰劑組達(dá)到臨床上減重5%以上的人數(shù)（64 vs 39%），10%以上的人數(shù)（23 vs 13%）。奧利司他治療組總膽固醇（-11.9 vs -4%；P＜0.001）和低密度脂蛋白 （-17.6 vs -7.6%；P＜0.001）改善更明顯。在雙盲實(shí)驗(yàn)期間，LDL-C的改善奧利司他治療組比安慰劑組更為明顯，這表明奧利司他除了減重之外還有直接的降低膽固醇的作用（P＜0.001）。開始服用安慰劑患者改用奧利司他后在體重，總膽固醇和LDL-C的降低上更明顯。與安慰劑組相比，奧利司他組安全性和耐受性都比較好，但胃腸道事件發(fā)生率稍高（64 vs 38%）。結(jié)論：服用奧利司他并適當(dāng)?shù)娘嬍掣深A(yù)可以對(duì)超重或肥胖兼高脂血癥患者達(dá)到明顯的降低體重和LDL-C的效果。
[關(guān)鍵詞] 肥胖；奧利司他；脂肪酶抑制；血脂；心血管危險(xiǎn)因素
文獻(xiàn)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.