Department of Cardiology, Gentofte Hospital, University of Copenhagen, Denmark.
BMC Endocr Disord. 2010 Feb 26;10:3. doi: 10.1186/1472-6823-10-3.
Obesity, type 2 diabetes mellitus (T2D) and unhealthy blood lipid profile are strongly associated with the risk of developing cardiovascular disease (CVD). We examined whether blood lipid changes with short term administration of the weight lowering drug, sibutramine and lifestyle modification in obese and overweight high-risk patients was associated with T2D status at screening.
The Sibutramine Cardiovascular OUTcomes (SCOUT) trial included obese and overweight patients at increased risk of cardiovascular events. All patients received guidance on diet and exercise plus once-daily 10 mg sibutramine during the 6-week, single blind lead-in period. Multivariable regression models were used to investigate factors associated with changes in lipid levels during the first four weeks of treatment.
A total of 10 742 patients received at least one dose of sibutramine during the 6-week lead-in period of SCOUT. After four weeks, patients experienced mean reductions in low density lipoprotein (LDL-C) 0.19 mmol/L, high density lipoprotein (HDL-C) 0.019 mmol/L, very low density lipoprotein (VLDL-C) 0.08 mmol/L, total cholesterol (TC) 0.31 mmol/L and triglycerides 0.24 mmol/L (p < 0.0001 for each). Four week changes in LDL-C, HDL-C and total cholesterol for patients without vs. with T2D were: LDL-C:-0.25 mmol/L vs. -0.18 mmol/L, P = 0.0004; HDL-C: -0.03 mmol/L vs. -0.02 mmol/L, P = 0.0014; total cholesterol: -0.37 mmol/l vs. -0.29 mmol/l, P = 0.0009. Multivariable regression analysis showed that similar decreases in body mass index (BMI) affected lipid changes differently according to diabetes status. A 1 kg/m2 decrease in BMI in patients with T2D was associated with -0.09 mmol/L in LDL-C (P < 0.0001) and -0.01 mmol/L in HDL-C (P = 0.0001) but larger changes of -0.16 mmol/L LDL-C and -0.03 mmol/L in HDL-C (P < 0.0001 for both) in patients without T2D.
Short term weight management with sibutramine therapy in obese or overweight high-risk patients induced significant mean reductions for all lipids. Those without T2D benefited most. Patients with hyperlipidaemia and the less obese patients also had greater falls in LDL-C and TC during weight loss. The trial is registered at ClinicalTrial.gov number: NCT00234832.
肥胖、2 型糖尿病（T2D）和血脂异常与心血管疾病（CVD）风险密切相关。我们研究了短期服用减肥药西布曲明和生活方式改变后，肥胖和超重高危患者的血脂变化是否与筛查时的 T2D 状态有关。
Sibutramine Cardiovascular OUTcomes（SCOUT）试验纳入了心血管事件风险增加的肥胖和超重患者。所有患者在 6 周的单盲导入期内接受饮食和运动指导，并每天服用 10mg 西布曲明。多变量回归模型用于研究治疗前 4 周内血脂水平变化的相关因素。
共有 10742 名患者在 SCOUT 的 6 周导入期内至少服用了一次西布曲明。四周后，患者的低密度脂蛋白（LDL-C）降低 0.19mmol/L，高密度脂蛋白（HDL-C）降低 0.019mmol/L，极低密度脂蛋白（VLDL-C）降低 0.08mmol/L，总胆固醇（TC）降低 0.31mmol/L，甘油三酯降低 0.24mmol/L（p<0.0001）。无 T2D 患者与有 T2D 患者的 LDL-C、HDL-C 和总胆固醇四周变化分别为：LDL-C：-0.25mmol/L 与-0.18mmol/L，P=0.0004；HDL-C：-0.03mmol/L 与-0.02mmol/L，P=0.0014；总胆固醇：-0.37mmol/L 与-0.29mmol/L，P=0.0009。多变量回归分析表明，根据糖尿病状况，体重指数（BMI）的相似下降对血脂变化的影响不同。T2D 患者 BMI 每降低 1kg/m2，LDL-C 降低 0.09mmol/L（P<0.0001），HDL-C 降低 0.01mmol/L（P=0.0001），但无 T2D 患者 LDL-C 降低 0.16mmol/L，HDL-C 降低 0.03mmol/L（均为 P<0.0001）。
肥胖或超重高危患者短期应用西布曲明治疗可显著降低所有血脂水平。无 T2D 的患者获益最大。血脂异常和体重较轻的患者在减肥过程中 LDL-C 和 TC 下降幅度也更大。该试验在 ClinicalTrial.gov 注册，编号为 NCT00234832。
