Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women
Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women
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DOI：
10.1056/nejmoa062462
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发表时间：
2006-07-13
影响因子：
158.5
通讯作者：
Wenger, Nanette K.
中科院分区：
文献类型：
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作者：
Barrett-Connor, Elizabeth;Mosca, Lori;Wenger, Nanette K.
背景：选择性雌激素受体调节剂雷洛昔芬对冠心病(CHD)和乳腺癌的作用尚未确定。方法：我们随机将10101名有冠心病或多种冠心病危险因素的绝经后妇女(平均年龄67.5岁)每天服用60 mg雷洛昔芬或安慰剂，并对她们进行了中位数5.6年的跟踪调查。结果：与安慰剂相比，雷洛昔芬对原发冠状动脉事件的风险没有显著影响(533比553个事件；风险比0.95；95%可信区间0.84到1.07)；它降低了浸润性乳腺癌的风险(40比70个事件；风险比0.56；95%可信区间0.38到0.83；绝对风险降低，每1000名妇女中1.2例浸润性乳腺癌接受治疗一年)；受益主要是由于雌激素受体阳性浸润性乳腺癌的风险降低。根据分组分配，任何原因或总中风的死亡率没有显著差异，但雷洛昔芬与致命中风的风险增加(59起对39起；风险比1.49；95%可信区间1.00至2.24；绝对风险增加，每1000妇女年0.7)和静脉血栓栓塞症(103起对71起；危险比1.44；95%可信区间1.06至1.95；绝对风险增加，每1000妇女年1.2)相关。雷洛昔芬降低了临床脊柱骨折的风险(与97个事件；风险比，0.65；95%可信区间，0.47至0.89；绝对风险降低，1.3/1000)。结论：雷洛昔芬对冠心病的风险没有显著影响。雷洛昔芬在降低浸润性乳腺癌和脊椎骨折风险方面的益处与静脉血栓栓塞症和致命中风风险的增加应加以权衡。
BACKGROUND:The effect of raloxifene, a selective estrogen-receptor modulator, on coronary heart disease (CHD) and breast cancer is not established.METHODS:We randomly assigned 10,101 postmenopausal women (mean age, 67.5 years) with CHD or multiple risk factors for CHD to 60 mg of raloxifene daily or placebo and followed them for a median of 5.6 years. The two primary outcomes were coronary events (i.e., death from coronary causes, myocardial infarction, or hospitalization for an acute coronary syndrome) and invasive breast cancer.)RESULTS:As compared with placebo, raloxifene had no significant effect on the risk of primary coronary events (533 vs. 553 events; hazard ratio, 0.95; 95 percent confidence interval, 0.84 to 1.07), and it reduced the risk of invasive breast cancer (40 vs. 70 events; hazard ratio, 0.56; 95 percent confidence interval, 0.38 to 0.83; absolute risk reduction, 1.2 invasive breast cancers per 1000 women treated for one year); the benefit was primarily due to a reduced risk of estrogen-receptor-positive invasive breast cancers. There was no significant difference in the rates of death from any cause or total stroke according to group assignment, but raloxifene was associated with an increased risk of fatal stroke (59 vs. 39 events; hazard ratio, 1.49; 95 percent confidence interval, 1.00 to 2.24; absolute risk increase, 0.7 per 1000 woman-years) and venous thromboembolism (103 vs. 71 events; hazard ratio, 1.44; 95 percent confidence interval, 1.06 to 1.95; absolute risk increase, 1.2 per 1000 woman-years). Raloxifene reduced the risk of clinical vertebral fractures (64 vs. 97 events; hazard ratio, 0.65; 95 percent confidence interval, 0.47 to 0.89; absolute risk reduction, 1.3 per 1000).CONCLUSIONS:Raloxifene did not significantly affect the risk of CHD. The benefits of raloxifene in reducing the risks of invasive breast cancer and vertebral fracture should be weighed against the increased risks of venous thromboembolism and fatal stroke.