Effect of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects
Effect of Sibutramine on Cardiovascular Outcomes in Overweight and Obese Subjects
复制标题
DOI：
10.1056/nejmoa1003114
复制
发表时间：
2010-09-02
影响因子：
158.5
通讯作者：
Renz, Cheryl L.
中科院分区：
文献类型：
--
作者：
James, W. Philip T.;Caterson, Ian D.;Renz, Cheryl L.
研究背景西布曲明治疗对高心血管风险受试者心血管事件和心血管死亡率的长期影响尚未确定。方法我们在我们的研究中招募了10，744名超重或肥胖受试者，年龄在55岁或以上，有预先存在的心血管疾病，2型糖尿病，或两者，以评估在心血管事件高风险受试者中使用和不使用西布曲明的体重管理的心血管后果。所有受试者除了在6周的单盲导入期内参加体重管理计划外，还接受了西布曲明，之后9804名受试者以双盲方式随机分配到西布曲明（4906名受试者）或安慰剂（4898名受试者）。主要终点是从随机分组到首次发生主要结局事件（非致死性心肌梗死、非致死性卒中、心脏骤停后复苏或心血管死亡）的时间。平均治疗持续时间为3.4年。导入期的平均体重减轻为2.6 kg;随机分组后，西布曲明组的受试者实现并保持了进一步的体重减轻（平均1.7 kg）。两组的平均血压均下降，安慰剂组的降幅大于西布曲明组（平均差异为1.2/1.4 mm Hg）。西布曲明组发生主要结局事件的风险为11.4%，而安慰剂组为10.0%（风险比，1.16; 95%可信区间[CI]，1.03 - 1.31; P = 0.02）。西布曲明组非致死性心肌梗死和非致死性卒中的发生率分别为4.1%和2.6%，安慰剂组分别为3.2%和1.9（非致死性心肌梗死的风险比为1.28; 95% CI为1.04 ~ 1.57; P = 0.02;非致死性卒中的风险比为1.36; 95% CI为1.04 ~ 1.77; P = 0.03）。心血管死亡和任何原因的死亡率没有增加。CONCLUSIONSSSubjects与预先存在的心血管疾病谁正在接受长期西布曲明治疗的非致命性心肌梗死和非致命性中风的风险增加，但不是心血管死亡或任何原因的死亡。
BACKGROUNDThe long-term effects of sibutramine treatment on the rates of cardiovascular events and cardiovascular death among subjects at high cardiovascular risk have not been established.METHODSWe enrolled in our study 10,744 overweight or obese subjects, 55 years of age or older, with preexisting cardiovascular disease, type 2 diabetes mellitus, or both to assess the cardiovascular consequences of weight management with and without sibutramine in subjects at high risk for cardiovascular events. All the subjects received sibutramine in addition to participating in a weight-management program during a 6-week, single-blind, lead-in period, after which 9804 subjects underwent random assignment in a double-blind fashion to sibutramine (4906 subjects) or placebo (4898 subjects). The primary end point was the time from randomization to the first occurrence of a primary outcome event (nonfatal myocardial infarction, nonfatal stroke, resuscitation after cardiac arrest, or cardiovascular death).RESULTSThe mean duration of treatment was 3.4 years. The mean weight loss during the lead-in period was 2.6 kg; after randomization, the subjects in the sibutramine group achieved and maintained further weight reduction (mean, 1.7 kg). The mean blood pressure decreased in both groups, with greater reductions in the placebo group than in the sibutramine group (mean difference, 1.2/1.4 mm Hg). The risk of a primary outcome event was 11.4% in the sibutramine group as compared with 10.0% in the placebo group (hazard ratio, 1.16; 95% confidence interval [CI], 1.03 to 1.31; P = 0.02). The rates of nonfatal myocardial infarction and nonfatal stroke were 4.1% and 2.6% in the sibutramine group and 3.2% and 1.9% in the placebo group, respectively (hazard ratio for nonfatal myocardial infarction, 1.28; 95% CI, 1.04 to 1.57; P = 0.02; hazard ratio for nonfatal stroke, 1.36; 95% CI, 1.04 to 1.77; P = 0.03). The rates of cardiovascular death and death from any cause were not increased.CONCLUSIONSSubjects with preexisting cardiovascular conditions who were receiving long-term sibutramine treatment had an increased risk of nonfatal myocardial infarction and nonfatal stroke but not of cardiovascular death or death from any cause.