雷洛昔芬对绝经后妇女心血管事件及乳腺癌的影响。

Effects of raloxifene on cardiovascular events and breast cancer in postmenopausal women.

作者信息

Barrett-Connor Elizabeth, Mosca Lori, Collins Peter, Geiger Mary Jane, Grady Deborah, Kornitzer Marcel, McNabb Michelle A, Wenger Nanette K

机构信息

Department of Family and Preventive Medicine, University of California, San Diego, La Jolla 92093-0607, USA.

出版信息

N Engl J Med. 2006 Jul 13;355(2):125-37. doi: 10.1056/NEJMoa062462.

DOI:10.1056/NEJMoa062462

PMID:16837676

Abstract

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. (ClinicalTrials.gov number, NCT00190593 [ClinicalTrials.gov].).

摘要

背景

选择性雌激素受体调节剂雷洛昔芬对冠心病（CHD）和乳腺癌的影响尚未明确。

方法

我们将10101名患有冠心病或具有多个冠心病危险因素的绝经后女性（平均年龄67.5岁）随机分为两组，一组每天服用60毫克雷洛昔芬，另一组服用安慰剂，并对她们进行了中位时间为5.6年的随访。两个主要结局是冠状动脉事件（即冠心病死亡、心肌梗死或因急性冠状动脉综合征住院）和浸润性乳腺癌。

结果

与安慰剂相比，雷洛昔芬对原发性冠状动脉事件风险无显著影响（533例事件 vs. 553例事件；风险比，0.95；95%置信区间，0.84至1.07），但它降低了浸润性乳腺癌的风险（40例事件 vs. 70例事件；风险比，0.56；95%置信区间，0.38至0.83；绝对风险降低，每1000名接受治疗一年的女性中有1.2例浸润性乳腺癌）；益处主要归因于雌激素受体阳性浸润性乳腺癌风险的降低。根据分组，两组在任何原因导致的死亡率或总中风发生率方面无显著差异，但雷洛昔芬与致命性中风风险增加相关（59例事件 vs. 39例事件；风险比，1.49；95%置信区间，1.00至2.24；绝对风险增加，每1000女性年中有0.7例）以及静脉血栓栓塞（103例事件 vs. 71例事件；风险比，1.44；95%置信区间，1.06至1.95；绝对风险增加，每1000女性年中有1.2例）。雷洛昔芬降低了临床椎体骨折的风险（64例事件 vs. 97例事件；风险比，0.65；95%置信区间，0.47至0.89；绝对风险降低，每1000例中有1.3例）。