HORMONE THERAPY EFFECTS ON CVD RISK FACTORS

激素治疗对 CVD 危险因素的影响

• 批准号: 2834176
• 负责人: MARK Andrew ESPELAND
• 金额: $ 6.56万
• 依托单位: WAKE FOREST UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-06-05 至 2000-06-04
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2834176
• 关键词: blood glucose; blood lipoprotein; blood pressure; bone metabolism; cardiovascular disorder; cardiovascular disorder epidemiology; cardiovascular disorder prevention; disease /disorder proneness /risk; endometrium; estrogens; female; hormone therapy; human data; insulin; outcomes research; progestins; women's health

Abstract: Cardiovascular disease is the leading cause of death among postmenopausal women. Growing evidence exists that HRT may reduce cardiovascular disease and mortality. This has led to the use of postmenopausal HRT for primary prevention of heart disease, however it remains unresolved which women are likely to benefit most from this clinical approach. This is a complicated question because many potential mechanisms are involved by which hormone therapy (HRT) may confer cardioprotection. The Postmenopausal Estrogen/Progestins Intervention (PEPI) trial examined the relative impact of four regimens of hormone therapy on a range of cardiovascular disease risk factors (e.g. lipids, blood pressure, insulin/glucose, hemostasis factors). The trial was well conducted; its data have been thoroughly edited and have yielded a series of important publications. To date, however, publications have focused on average effects without a thorough exploration of the range of, and interplay among, the various effects across the 875 enrolled in the trial. We propose to extend the analysis of PEPI data: 1) characterize the distributions of responses to hormone therapy with respect to risk factors for cardiovascular disease (lipids/lipoproteins, blood pressure, insulin/glucose, hemostasis factors); 2) examine the multivariate patterns of treatment effects among these cardiovascular risk factors and on other outcomes (symptomatology, bone, endometrial); 3) examine clinical and demographic factors that may affect these relationships and, in doing so, characterize women who may vary with respect to their "sensitivity" to the separate effects of estrogen and progestin therapy; 4) examine closely patterns of adherence and their relationship to response. An experienced team of statisticians/epidemiologists is proposed to conduct and publish results from these analyses. Its members are thoroughly familiar with the data from the PEPI trial. The results of the proposed analyses are expected to hold considerable clinical significance and may help to interpret emerging findings from event-based trials.

翻译后摘要：心血管疾病是绝经后妇女死亡的主要原因。 越来越多的证据表明HRT可以减少心血管疾病和死亡率。 这导致了绝经后HRT用于心脏病的一级预防，但仍未解决哪些女性可能从这种临床方法中获益最多。 这是一个复杂的问题，因为激素治疗（HRT）可能涉及许多潜在的机制。绝经后雌激素/孕激素干预（PEPI）试验检查了四种激素治疗方案对一系列心血管疾病风险因素（如血脂、血压、胰岛素/葡萄糖、止血因素）的相对影响。 试验进行得很好;试验数据经过彻底编辑，并产生了一系列重要出版物。 然而，到目前为止，出版物都集中在平均效应上，而没有深入探讨875例入组试验的各种效应的范围和相互作用。我们建议扩展PEPI数据的分析：1）描述激素治疗反应与心血管疾病危险因素的分布特征（脂质/脂蛋白、血压、胰岛素/葡萄糖、止血因素）; 2）检查这些心血管危险因素和其他结局中治疗效果的多变量模式（妇科学、骨、子宫内膜）; 3）检查可能影响这些关系的临床和人口统计学因素，并且在这样做时，表征可能在其对雌激素和孕酮治疗的单独作用的“敏感性”方面变化的妇女; 4）仔细检查坚持的模式及其与反应的关系。建议由一个经验丰富的统计学家/流行病学家小组进行这些分析并发表分析结果。 其成员完全熟悉PEPI试验的数据。 预计拟议分析的结果将具有相当大的临床意义，并可能有助于解释基于事件的试验中出现的结果。