Effects of the selective estrogen receptor modulator raloxifene on coronary outcomes in the Raloxifene Use for The Heart trial: results of subgroup analyses by age and other factors.
Effects of the selective estrogen receptor modulator raloxifene on coronary outcomes in the Raloxifene Use for The Heart trial: results of subgroup analyses by age and other factors.
复制标题
选择性雌激素受体调节剂Raloxifene对心脏试验雷昔芬使用中冠状动脉结局的影响：按年龄和其他因素分析亚组分析的结果。
DOI：
10.1161/circulationaha.108.817577
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发表时间：
2009-02-24
期刊：
影响因子：
37.8
通讯作者：
Wenger NK
中科院分区：
文献类型：
--
作者：
Collins P;Mosca L;Geiger MJ;Grady D;Kornitzer M;Amewou-Atisso MG;Effron MB;Dowsett SA;Barrett-Connor E;Wenger NK
雷洛昔芬用于心脏（RUTH）试验表明，雷洛昔芬是一种选择性雌激素受体调节剂，对患有冠心病或冠心病危险因素的妇女的冠状动脉事件发生率没有总体影响。我们提供了雷洛昔芬随时间和24个亚组（17个预先设定的，7个事后设定的）对冠状动脉结局影响的详细结果。绝经后妇女（n = 10101，平均年龄67岁）随机接受雷洛昔芬60 mg/d或安慰剂治疗，中位时间为5.6年。对有冠心病危险因素的妇女和已确诊冠心病的妇女的冠状动脉结局进行治疗组评估。雷洛昔芬对任何亚组的冠状动脉事件发生率都没有影响，除了使用妇女健康倡议随机试验中定义的年龄类别进行的事后年龄亚组分析。雷洛昔芬对冠状动脉事件发生率的影响因年龄而异（相互作用P = 0.0118）。与安慰剂组相比，使用雷洛昔芬组<60岁女性冠状动脉事件的发生率（50个事件）显著降低（84个事件；风险比0.59；95%可信区间0.41 ~ 0.83;P = 0.003；绝对风险降低，每1000名接受1年治疗的女性中有36人）。≥60岁、<70岁或≥70岁女性的冠状动脉事件发生率在治疗组之间没有差异。在冠状动脉事件风险增加的绝经后妇女中，雷洛昔芬总体缺乏益处在预先指定的亚组中是相似的。
The Raloxifene Use for The Heart (RUTH) trial showed that raloxifene, a selective estrogen receptor modulator, had no overall effect on the incidence of coronary events in women with established coronary heart disease or coronary heart disease risk factors. We provide detailed results of the effect of raloxifene on coronary outcomes over time and for 24 subgroups (17 predefined, 7 post hoc). Postmenopausal women (n = 10 101; mean age, 67 years) were randomized to raloxifene 60 mg/d or placebo for a median of 5.6 years. Coronary outcomes were assessed by treatment group in women with coronary heart disease risk factors and those with established coronary heart disease. Raloxifene had no effect on the incidence of coronary events in any subgroup except in the case of a post hoc age subgroup analysis using age categories defined in the Women’s Health Initiative randomized trials. The effect of raloxifene on the incidence of coronary events differed significantly by age (interaction P = 0.0118). The incidence of coronary events in women <60 years of age was significantly lower in those assigned raloxifene (50 events) compared with placebo (84 events; hazard ratio, 0.59; 95% confidence interval, 0.41 to 0.83; P = 0.003; absolute risk reduction, 36 per 1000 women treated for 1 year). No difference was found between treatment groups in the incidence of coronary events in women ≥60 and <70 or ≥70 years of age. In postmenopausal women at increased risk of coronary events, the overall lack of benefit of raloxifene was similar across the prespecified subgroups.