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【NEJM】辛伐他汀联合依折麦布强化降脂治疗不能
Anne B. Rossebø, M.D., Terje R. Pedersen, M.D., Ph.D., Kurt Boman, M.D., Ph.D., Philippe Brudi, M.D., John B. Chambers, M.D., Kenneth Egstrup, M.D., Ph.D., Eva Gerdts, M.D., Ph.D., Christa Gohlke-Bärwolf, M.D., Ingar Holme, Ph.D., Y. Antero Kesäniemi, M.D., Ph.D., William Malbecq, Ph.D., Christoph A. Nienaber, M.D., Ph.D., Simon Ray, M.D., Terje Skjærpe, M.D., Ph.D., Kristian Wachtell, M.D., Ph.D., Ronnie Willenheimer, M.D., Ph.D., for the SEAS Investigators
Background Hyperlipidemia has been suggested as a risk factor for stenosis of the aortic valve, but lipid-lowering studies have had conflicting results.
Methods We conducted a randomized, double-blind trial involving 1873 patients with mild-to-moderate, asymptomatic aortic stenosis. The patients received either 40 mg of simvastatin plus 10 mg of ezetimibe or placebo daily. The primary outcome was a composite of major cardiovascular events, including death from cardiovascular causes, aortic-valve replacement, nonfatal myocardial infarction, hospitalization for unstable angina pectoris, heart failure, coronary-artery bypass grafting, percutaneous coronary intervention, and nonhemorrhagic stroke. Secondary outcomes were events related to aortic-valve stenosis and ischemic cardiovascular events.
Results During a median follow-up of 52.2 months, the primary outcome occurred in 333 patients (35.3%) in the simvastatin–ezetimibe group and in 355 patients (38.2%) in the placebo group (hazard ratio in the simvastatin–ezetimibe group, 0.96; 95% confidence interval [CI], 0.83 to 1.12; P=0.59). Aortic-valve replacement was performed in 267 patients (28.3%) in the simvastatin–ezetimibe group and in 278 patients (29.9%) in the placebo group (hazard ratio, 1.00; 95% CI, 0.84 to 1.18; P=0.97). Fewer patients had ischemic cardiovascular events in the simvastatin–ezetimibe group (148 patients) than in the placebo group (187 patients) (hazard ratio, 0.78; 95% CI, 0.63 to 0.97; P=0.02), mainly because of the smaller number of patients who underwent coronary-artery bypass grafting. Cancer occurred more frequently in the simvastatin–ezetimibe group (105 vs. 70, P=0.01).
Conclusions Simvastatin and ezetimibe did not reduce the composite outcome of combined aortic-valve events and ischemic events in patients with aortic stenosis. Such therapy reduced the incidence of ischemic cardiovascular events but not events related to aortic-valve stenosis. (ClinicalTrials.gov number, NCT00092677 [ClinicalTrials.gov] .)
Intensive Lipid Lowering with Simvastatin and Ezetimibe in Aortic Stenosis
辛伐他汀联合依折麦布强化降脂对主动脉瓣狭窄的作用
Background Hyperlipidemia has been suggested as a risk factor for stenosis of the aortic valve, but lipid-lowering studies have had conflicting results.
背景，高血脂已经被认为是主动脉瓣狭窄的危险因子，但有关降脂治疗的研究却得出了矛盾的结果。
Methods We conducted a randomized, double-blind trial involving 1873 patients with mild-to-moderate, asymptomatic aortic stenosis. The patients received either 40 mg of simvastatin plus 10 mg of ezetimibe or placebo daily. The primary outcome was a composite of major cardiovascular events, including death from cardiovascular causes, aortic-valve replacement, nonfatal myocardial infarction, hospitalization for unstable angina pectoris, heart failure, coronary-artery bypass grafting, percutaneous coronary intervention, and nonhemorrhagic stroke. Secondary outcomes were events related to aortic-valve stenosis and ischemic cardiovascular events.
方法：我们开展了一项随机、双盲研究，纳入了1873例轻中度，非症状性主动脉狭窄患者。患者接受每日40mg辛伐他汀联合10mg依折麦布或安慰剂治疗。主要终点为主要心血管事件的联合终点，包括心血管原因死亡、主动脉瓣置换、非致死性心肌梗死、因不稳定型心绞痛住院、心力衰竭、冠脉搭桥术、经皮冠状动脉介入和非缺血性卒中。次要终点为与主动脉瓣狭窄相关的事件和缺血性心血管事件。
Results During a median follow-up of 52.2 months, the primary outcome occurred in 333 patients (35.3%) in the simvastatin–ezetimibe group and in 355 patients (38.2%) in the placebo group (hazard ratio in the simvastatin–ezetimibe group, 0.96; 95% confidence interval [CI], 0.83 to 1.12; P=0.59). Aortic-valve replacement was performed in 267 patients (28.3%) in the simvastatin–ezetimibe group and in 278 patients (29.9%) in the placebo group (hazard ratio, 1.00; 95% CI, 0.84 to 1.18; P=0.97). Fewer patients had ischemic cardiovascular events in the simvastatin–ezetimibe group (148 patients) than in the placebo group (187 patients) (hazard ratio, 0.78; 95% CI, 0.63 to 0.97; P=0.02), mainly because of the smaller number of patients who underwent coronary-artery bypass grafting. Cancer occurred more frequently in the simvastatin–ezetimibe group (105 vs. 70, P=0.01).
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作者:admin@医学,生命科学 2010-11-26 17:11
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