Endogenous/Exogenous Sex Hormones & CHD Risk Factors

描述(由申请人提供)： 冠心病(CHD)是美国女性最常见的死亡原因。 观察性研究一致地表明，绝经后雌激素与或 没有孕激素，可以降低患冠心病的风险，有几个看似合理的 雌激素保护心脏的机制。尽管如此，临床 到目前为止，试验还没有证明对心脏有保护作用。如果荷尔蒙水平影响 绝经后妇女和激素替代疗法在确定冠心病风险中的作用 作为降低风险的一种手段，内源性激素的相互作用， HRT和CHD风险因素需要进一步定义，特别是 协变量。个体特征，如基础激素水平，身体 大小、过去的激素使用和生活方式的决定可能会改变对HRT的反应。 这一建议的重点是四个问题：1)什么因素决定了循环 绝经后妇女的性激素水平，2)什么因素决定变化 激素替代疗法(HRT)对性激素水平的影响 绝经后内源性性激素水平对冠心病危险因素的影响 女性，以及4)性激素水平随HRT的变化是否可以预测 激素替代疗法对冠心病危险因素的影响。这些问题将通过分析 绝经后雌激素/孕激素干预试验的现有数据 (PEPI)，一项为期3年的多中心、双盲、安慰剂对照试验 旨在比较单独使用雌激素和3种雌激素/孕激素替代疗法的效果。 在选定的冠心病危险因素上，方案与安慰剂的比较。共有875名参与者。 血清性激素水平、冠心病危险因素和潜在的协变量 (包括人口统计特征、人体测量、 生育史和生活方式变量)，在基线和 24或36个月的治疗，将在分析中考虑。结果： 这项研究将有助于确定女性在以下方面的差异 内源性性激素水平和对激素替代疗法的反应，以及性别的关系 荷尔蒙对冠心病危险因素的影响。这些观察结果可能有助于决定 妇女应该单独使用激素替代疗法，如果是这样的话，哪种方案将提供 大多数人以最小的风险受益。

DESCRIPTION (provided by applicant): Coronary heart disease (CHD) is the most common cause of death in U.S. women. Observational studies consistently show that postmenopausal estrogen, with or without a progestin, reduces the risk of CHD, and there are several plausible mechanisms by which estrogen might protect the heart. Nevertheless, clinical trials to date have not demonstrated cardioprotection. If hormone levels play a role in determining CHD risk in postmenopausal women and HRT is to be used as a means of reducing that risk, the interactions of endogenous hormones, HRT, and CHD risk factors need further definition, in particular the effect of covariates. Individual characteristics such as basal hormone levels, body size, past hormone use, and lifestyle decisions may modify responses to HRT. This proposal focuses on four questions: 1) what factors determine circulating sex hormone levels in postmenopausal women, 2) what factors determine changes in sex hormone levels in response to hormone replacement therapy (HRT), 3) do endogenous sex hormone levels influence CHD risk factors in postmenopausal women, and 4) do changes in sex hormone levels with HRT predict the effect of HRT on CHD risk factors. These questions will be addressed by analyzing existing data from the Postmenopausal Estrogen / Progestin Interventions Trial (PEPI), a 3-year, multi-center, double-blind, placebo-controlled trial designed to compare the effect of estrogen alone and 3 estrogen/progestin HRT regimens vs placebo on selected CHD risk factors. There were 875 participants. Serum sex hormone levels, CHD risk factors, and potential covariates (including demographic characteristics, anthropometric measurements, reproductive history and lifestyle variables), determined at baseline and at 24 or 36 months of treatment, will be considered in the analyses. Results of this study will help define the differences between women with regard to endogenous sex hormone levels and responses to HRT, and the relation of sex hormones to CHD risk factors. These observations may aid in deciding whether individual women should use HRT and, if so, which regimen would provide the most benefit with the least risk.