Cardiovascular effects of tamoxifen in women with and without heart disease: Breast cancer prevention trial
Cardiovascular effects of tamoxifen in women with and without heart disease: Breast cancer prevention trial
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DOI：
10.1093/jnci/93.1.16
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发表时间：
2001-01-03
期刊：
影响因子：
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通讯作者：
Kavanah, M
中科院分区：
文献类型：
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作者：
Reis, SE;Costantino, JP;Kavanah, M
背景资料：预防性他莫昔芬对女性的总体影响取决于药物作用之间的平衡，包括预防乳腺癌和改变心血管风险。在最近的一项临床试验中，绝经后雌激素-孕激素治疗被证明会增加有冠心病（CHD）病史的女性早期心血管事件的风险。他莫昔芬对患有和不患有CHD的女性的心血管影响尚不清楚。国家外科辅助乳腺和肠道项目乳腺癌预防试验（BCPT）是唯一的临床试验，提供的数据，以评估他莫昔芬的心血管作用的妇女与非冠心病，方法：共有13 388名妇女在乳腺癌的风险增加被随机分配在BCPT接受他莫昔芬（20毫克/天）或安慰剂。对13194名女性进行了心血管随访，其中1048名既往有临床CHD、致死性和非致死性心肌梗死、不稳定型心绞痛和重度心绞痛（平均随访时间：49个月）。所有统计检验均为双侧检验。结果如下：接受他莫昔芬治疗的女性与接受安慰剂治疗的女性之间的心血管事件发生率无统计学显著差异，与既存CHD无关。（他莫昔芬组6074例vs安慰剂组6072例），风险比（95%置信区间[CI]）为1.75（0.44至8.13）对于致死性心肌梗死，1.11非致死性心肌梗死为0.55 ~ 2.28，不稳定型心绞痛为0.69（0.29 ~ 1.57），重度心绞痛为0.83（0.32 ~ 2.10）。女性CHD患者（他莫昔芬组516例，安慰剂组532例），他莫昔芬使用者的风险比（95%CI）为0.00（0 - 1.58）对于致死性心肌梗死，1.25非致死性心肌梗死组为0.32 ~ 5.18，不稳定型心绞痛组为2.26（0.87 ~ 6.55），重度心绞痛组为1.39（0.23 ~ 9.47）。没有证据表明他莫昔芬和心血管事件之间缺乏相关性与早期风险增加有关，而早期风险增加可能被晚期风险降低所抵消。结论：当用于有或无心脏病的女性乳腺癌预防时，他莫昔芬与有益或不利的心血管作用无关。
Background: The overall effect of prophylactic tamoxifen in women depends on the balance between the effects of the drug, which include preventing breast cancer and altering cardiovascular risk. In a recent clinical trial, postmenopausal estrogen-progestin therapy was shown to increase the risk of early cardiovascular events among women with a history of coronary heart disease (CHD). The cardiovascular effects of tamoxifen in women with and without CHD are not known.: The National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial (BCPT) is the only clinical trial that provides data to assess the cardiovascular effects of tamoxifen in women with and without CHD, Methods: A total of 13 388 women at increased risk for breast cancer were randomly assigned in the BCPT to receive either tamoxifen (20 mg/day) or placebo. Cardiovascular follow-up was available for 13 194 women, 1048 of whom had prior clinical CHD, Fatal and nonfatal myocardial infarction, unstable angina, and severe angina were tabulated (mean follow-up: 49 months). All statistical tests were two-sided. Results: Cardiovascular event rates were not statistically significantly different between women assigned to receive tamoxifen and those assigned to receive placebo, independent of pre-existing CHD, Among women without CHD (6074 on tamoxifen versus 6072 on placebo), risk ratios (95% confidence intervals [CIs]) for tamoxifen users were 1.75 (0.44 to 8.13) for fatal myocardial infarction, 1.11 (0.55 to 2.28) for nonfatal myocardial infarction, 0.69 (0.29 to 1.57) for unstable angina, and 0.83 (0.32 to 2.10) for severe angina. In women with CHD (516 on tamoxifen versus 532 on placebo), risk ratios (95% CIs) for tamoxifen users were 0.00 (0 to 1.58) for fatal myocardial infarction, 1.25 (0.32 to 5.18) for nonfatal myocardial infarction, 2.26 (0.87 to 6.55) for unstable angina, and 1.39 (0.23 to 9.47) for severe angina. There was no evidence that the lack of association between tamoxifen and cardiovascular events was related to an early increase in risk that may have been offset by a late decrease in risk. Conclusion: When used for breast cancer prevention in women with or without heart disease, tamoxifen is not associated with beneficial or adverse cardiovascular effects.