Effect of raloxifene on stroke and venous thromboembolism according to subgroups in postmenopausal women at increased risk of coronary heart disease.
Effect of raloxifene on stroke and venous thromboembolism according to subgroups in postmenopausal women at increased risk of coronary heart disease.
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DOI：
10.1161/strokeaha.108.518621
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发表时间：
2009-01
期刊：
影响因子：
8.3
通讯作者：
Kornitzer M
中科院分区：
文献类型：
--
作者：
Mosca L;Grady D;Barrett-Connor E;Collins P;Wenger N;Abramson BL;Paganini-Hill A;Geiger MJ;Dowsett SA;Amewou-Atisso M;Kornitzer M
雷洛昔芬是一种选择性雌激素受体调节剂，可降低侵袭性乳腺癌和骨质疏松症的风险，但对不同患者亚组中风和静脉血栓栓塞风险的影响尚未确定。本分析的目的是根据参与者亚组评估雷洛昔芬对所有中风、中风死亡和静脉血栓栓塞事件发生率的影响。这是一项国际随机安慰剂对照临床试验的次要终点分析，该试验纳入了 10101 名患有冠心病或冠心病风险增加的绝经后妇女，随访时间中位数为 5.6 年。中风、静脉血栓栓塞事件和死亡由专家集中委员会裁决。中风被分为缺血性、出血性或未确定性，静脉血栓栓塞事件被细分。雷洛昔芬（每 100 名女性年的发病率=0.95）和安慰剂（发病率=0.86）治疗组之间所有卒中的发生率没有差异（P=0.30）。在接受雷洛昔芬治疗的女性中，与安慰剂组相比，致命性中风（发生率分别为 0.22 和 0.15，P=0.0499）和静脉血栓栓塞事件（发生率分别为 0.39 和 0.27，P=0.02）的发生率较高。除了当前吸烟者中与雷洛昔芬使用相关的中风发病率较高之外，没有发现显着的亚组相互作用。在冠状动脉事件风险增加的绝经后女性中，接受雷洛昔芬治疗的女性静脉血栓栓塞和致命性中风（但并非所有中风）的发生率均高于安慰剂组。雷洛昔芬的效果在不同亚组之间没有差异，只是中风的风险因吸烟状况而异。关于雷洛昔芬的治疗决策应基于预计绝对风险和获益的平衡。
Raloxifene, a selective estrogen receptor modulator, reduces risk of invasive breast cancer and osteoporosis, but the effect on risk for stroke and venous thromboembolism in different patient subgroups is not established. The purpose of this analysis was to evaluate the effect of raloxifene on the incidence of all strokes, stroke deaths, and venous thromboembolic events according to participant subgroups. This was a secondary end point analysis of an international, randomized, placebo-controlled clinical trial of 10 101 postmenopausal women with or at increased risk of coronary heart disease followed a median of 5.6 years. Strokes, venous thromboembolic events, and deaths were adjudicated by expert centralized committees. Strokes were categorized as ischemic, hemorrhagic, or undetermined and venous thromboembolic events were subclassified. The incidences of all strokes did not differ between raloxifene (incidence rate per 100 woman-years=0.95) and placebo (incidence rate=0.86) treatment groups (P=0.30). In women assigned raloxifene versus placebo, there was a higher incidence of fatal strokes (incidence rates=0.22 and 0.15, respectively, P=0.0499) and venous thromboembolic events (incidence rates=0.39 and 0.27, respectively, P=0.02). No significant subgroup interactions were found except that there was a higher incidence of stroke associated with raloxifene use among current smokers. In postmenopausal women at increased risk for coronary events, the incidences of venous thromboembolism and fatal stroke but not all strokes were higher in those assigned raloxifene versus placebo. Raloxifene's effect did not differ across subgroups, except that the risk of stroke differed by smoking status. Treatment decisions about raloxifene should be based on a balance of projected absolute risks and benefits.