Hill J O, Hauptman J, Anderson J W, Fujioka K, O'Neil P M, Smith D K, Zavoral J H, Aronne L J
University of Colorado Health Sciences Center, Denver, USA.
Am J Clin Nutr. 1999 Jun;69(6):1108-16. doi: 10.1093/ajcn/69.6.1108.
Long-term maintenance of weight loss remains a therapeutic challenge in obesity treatment.
This multicenter, double-blind, placebo-controlled study was designed to test the hypothesis that orlistat, a gastrointestinal lipase inhibitor, is significantly more effective than a placebo in preventing weight regain.
Obese subjects who lost > or = 8% of their initial body weight during a 6-mo lead-in of a prescribed hypoenergetic diet (4180-kJ/d deficit) with no adjunctive pharmacotherapy were randomly assigned to receive placebo, 30 mg orlistat, 60 mg orlistat, or 120 mg orlistat 3 times daily for 1 y in combination with a maintenance diet to help prevent weight regain. Of 1313 recruited subjects [body mass index (in kg/m2): 28-43], 729 subjects lost > or =8% of their initial body weight during the 6-mo weight-loss lead-in period and were enrolled in the double-blind phase.
After 1 y, subjects treated with 120 mg orlistat 3 times daily regained less weight than did placebo-treated subjects (32.8 +/- 4.5% compared with 58.7 +/- 5.8% regain of lost weight; P < 0.001). Moreover, more subjects in the 120-mg orlistat group than in the placebo group regained < or = 25% of lost weight (47.5% of subjects compared with 29.9%). In addition, orlistat treatment (120 mg 3 times daily) was associated with significantly greater reductions in total and LDL-cholesterol concentrations than was placebo (P < 0.001).
The use of orlistat during periods of attempted weight maintenance minimizes weight readjustment and facilitates long-term improvement in obesity-related disease risk factors.
长期维持体重减轻仍是肥胖症治疗中的一项治疗挑战。
本多中心、双盲、安慰剂对照研究旨在检验以下假设：胃肠道脂肪酶抑制剂奥利司他在预防体重反弹方面比安慰剂显著更有效。
在为期6个月的规定低能量饮食（每日热量 deficit 4180千焦）导入期内体重减轻≥初始体重8%且未接受辅助药物治疗的肥胖受试者，被随机分配接受安慰剂、30毫克奥利司他、60毫克奥利司他或120毫克奥利司他，每日3次，持续1年，并结合维持性饮食以帮助预防体重反弹。在1313名招募的受试者[体重指数（千克/平方米）：28 - 43]中，729名受试者在6个月的体重减轻导入期内体重减轻≥初始体重的8%，并进入双盲阶段。
1年后，每日3次服用120毫克奥利司他的受试者体重反弹比服用安慰剂的受试者少（体重反弹分别为减重的32.8±4.5%和58.7±5.8%；P<0.001）。此外，120毫克奥利司他组体重反弹≤减重25%的受试者比安慰剂组更多（分别为47.5%和29.9%）。此外，与安慰剂相比，奥利司他治疗（每日3次，120毫克）使总胆固醇和低密度脂蛋白胆固醇浓度显著降低更多（P<0.001）。
在试图维持体重期间使用奥利司他可使体重重新调整最小化，并有助于长期改善肥胖相关疾病风险因素。
