Derosa G, Cicero A F G, Murdolo G, Ciccarelli L, Fogari R
Department of Internal Medicine and Therapeutics, University of Pavia, Pavia, Italy.
Diabetes Nutr Metab. 2004 Aug;17(4):222-9.
The aim of our study was to comparatively evaluate the efficacy and safety of orlistat and sibutramine treatment in obese diabetic patients of both sexes, with specific attention to metabolic pattern-induced changes and cardiovascular effects.
Patients were enrolled, evaluated, and followed in 3 Italian Centres of Internal Medicine. We evaluated 144 obese diabetic patients. All were required to have been diagnosed as being diabetic for at least 6 months, and had glycaemic control with diet alone or diet and oral hypoglycaemic agents. We administered orlistat (360 mg/d) or sibutramine (10 mg/d) in a randomized, controlled, double-blind clinical study, and evaluated anthropometric variables, glycaemic control, blood pressure and heart rate (HR) during 12 months of this treatment.
A total of 141 (69 males and 72 females; 35 males and 36 females, aged 53 +/- 5 yr with orlistat; 34 males and 36 females, aged 51 +/- 4 yr with sibutramine) completed the 4 weeks on controlled-energy diet and were randomized to double-blind treatment with orlistat (n=71) or sibutramine (n=70). Significant body mass index (BMI) improvement was present after 6 (p<0.05), 9 (p<0.02), and 12 (p<0.01) months in both groups. Significant waist circumference (WC), hip circumference (HC), and waist/hip ratio (W/H ratio) improvement was observed after 12 months (p<0.05, respectively) in both groups. Significant HbA1c decrease was obtained after 6 (p<0.05), 9 (p<0.02), and 12 (p<0.01) months in both groups. After 9 and 12 months, mean fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG) levels were significantly decreased in both groups (p<0.05 andp<0.02, respectively). Significant systolic blood pressure (SBP) and diastolic blood pressure (DBP) improvement (p<0.05) was present in the orlistat group after 12 months. No significant change in blood pressure measurements was observed in the sibutramine group during the study. No significant HR variation was obtained during the study in either group. Of the 133 patients who completed the study, 33.8% of patients in the orlistat group and 13.2% of patients in the sibutramine group had side effects (p<0.05 vs orlistat group). Side effect profiles were different in the two treatmen groups. All orlistat side effects were gastrointestinal events. Sibutramine caused an increase in blood pres sure (both SBP and DBP) in one patient, but it was controlled by anti-hypertensive treatment. The vita min changes were small and all mean vitamin and beta-carotene values stayed within reference ranges. No patients required vitamin supplementation.
Both orlistat and sibutramine were effective on anthropometric variables and on metabolic pattern during the 12-month treatment; in our sample, orlistat appears to be slightly more efficacious as an anti-obesity drug, while sibutramine intake was not associated to any cardiovascular effect and was generally better tolerated than orlistat.
本研究旨在比较评价奥利司他和西布曲明治疗肥胖糖尿病患者（包括男性和女性）的疗效和安全性，特别关注代谢模式变化及心血管效应。
在3个意大利内科中心招募、评估并随访患者。我们评估了144例肥胖糖尿病患者。所有患者均需已被诊断为糖尿病至少6个月，且仅通过饮食或饮食加口服降糖药控制血糖。在一项随机、对照、双盲临床研究中，我们给予患者奥利司他（360mg/d）或西布曲明（10mg/d），并在治疗的12个月期间评估人体测量学变量、血糖控制情况、血压和心率（HR）。
共有141例患者（69例男性和72例女性；使用奥利司他的35例男性和36例女性，年龄53±5岁；使用西布曲明的34例男性和36例女性，年龄51±4岁）完成了4周的能量控制饮食，并被随机分为接受奥利司他（n=71）或西布曲明（n=70）的双盲治疗。两组在治疗6个月（p<0.05）、9个月（p<0.02）和12个月（p<0.01）后体重指数（BMI）均有显著改善。两组在治疗12个月后腰围（WC）、臀围（HC）和腰臀比（W/H比）均有显著改善（p<0.05）。两组在治疗6个月（p<0.05）、9个月（p<0.02）和12个月（p<0.01）后糖化血红蛋白（HbA1c）均显著降低。9个月和12个月后，两组的空腹血糖（FPG）和餐后血糖（PPG）平均水平均显著降低（分别为p<0.05和p<0.02）。奥利司他组在治疗12个月后收缩压（SBP）和舒张压（DBP）有显著改善（p<0.05）。在研究期间，西布曲明组血压测量无显著变化。在研究期间，两组心率均无显著变化。在完成研究的133例患者中，奥利司他组33.8%的患者和西布曲明组13.2%的患者有副作用（与奥利司他组相比，p<0.05）。两个治疗组的副作用情况不同。奥利司他的所有副作用均为胃肠道事件。西布曲明使1例患者血压（SBP和DBP）升高，但通过抗高血压治疗得到控制。维生素变化较小，所有维生素和β-胡萝卜素的平均水平均保持在参考范围内。无需患者补充维生素。
在12个月的治疗期间，奥利司他和西布曲明对人体测量学变量和代谢模式均有效；在我们的样本中，奥利司他作为一种抗肥胖药物似乎疗效稍好，而服用西布曲明未出现任何心血管效应，且总体耐受性优于奥利司他。
