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在他莫昔芬治疗 5 年后接受来曲唑治疗的绝经后女性的血脂浓度:NCIC CTG MA.17 子研究。

Lipid concentrations in postmenopausal women on letrozole after 5 years of tamoxifen: an NCIC CTG MA.17 sub-study.

机构信息

Faculty of Pharmaceutical Sciences, The University of British Columbia, Vancouver, BC, V6T 1Z3, Canada.

出版信息

Breast Cancer Res Treat. 2012 Dec;136(3):769-76. doi: 10.1007/s10549-012-2294-z. Epub 2012 Oct 23.

DOI:10.1007/s10549-012-2294-z
PMID:23089983
Abstract

To evaluate changes in serum lipid parameters (cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, and lipoprotein(a) [Lp(a)]), in postmenopausal women receiving letrozole after tamoxifen therapy. MA.17L is a sub-study of MA.17, a double-blind, placebo-controlled trial of extended adjuvant letrozole. Eligible postmenopausal women were non-hyperlipidemic and not on lipid-lowering drugs. This analysis considers the 183 patients on the letrozole arm. Lipid parameters evaluated at baseline, 6 months, 12 months, and yearly thereafter until completion of 5 years of letrozole. The median duration of letrozole treatment was 5.0 years with a range from 0.03 to 6.05 years. After 5 year tamoxifen, patients on letrozole experienced significant increases from baseline in total cholesterol, LDL cholesterol, and Lp(a) at all study time points but no statistically significant changes in triglycerides. Specifically, a statistically significant increase was found at 60 months in total cholesterol [mean percentage change from baseline (PC) 5.27; p = 0.003], HDL cholesterol (mean PC 6.75; p = 0.003), LDL cholesterol (mean PC 10.02; p = 0.001), Lp(a) (mean PC 105.95; p < 0.0001). 103 (56 %) women in the study had clinically significantly elevated levels of Lp(a) (106 % above baseline) after 5 years of therapy. The results were similar after excluding the 21 % of patients who had ever received anti-lipid treatment. Significant increases in total cholesterol, HDL cholesterol, LDL cholesterol, and, most notably, Lp(a) in postmenopausal women were observed following 5 years of adjuvant letrozole treatment and after 5 years of tamoxifen therapy and such patients should have monitoring of their lipid levels in clinical practice.

摘要

评估接受他莫昔芬治疗后的绝经后妇女接受来曲唑治疗后血清脂质参数(胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇、甘油三酯和脂蛋白(a)[Lp(a)])的变化。MA.17L 是 MA.17 的子研究,这是一项来曲唑延长辅助治疗的双盲、安慰剂对照试验。合格的绝经后妇女非高脂血症且未服用降脂药物。本分析考虑了来曲唑组的 183 名患者。在基线、6 个月、12 个月和此后每年进行脂质参数评估,直到完成来曲唑 5 年治疗。来曲唑治疗的中位持续时间为 5.0 年,范围为 0.03 至 6.05 年。在接受 5 年他莫昔芬治疗后,接受来曲唑治疗的患者在所有研究时间点的总胆固醇、低密度脂蛋白胆固醇和 Lp(a)均从基线显著升高,但甘油三酯无统计学显著变化。具体而言,在 60 个月时发现总胆固醇有统计学显著增加[与基线相比的平均百分比变化(PC)为 5.27;p = 0.003]、高密度脂蛋白胆固醇(平均 PC 为 6.75;p = 0.003)、低密度脂蛋白胆固醇(平均 PC 为 10.02;p = 0.001)和 Lp(a)(平均 PC 为 105.95;p < 0.0001)。在研究中,103 名(56%)女性在 5 年治疗后 Lp(a)水平升高(比基线高 106%),临床意义显著。在排除了 21%曾经接受过降脂治疗的患者后,结果相似。在接受他莫昔芬治疗 5 年后和来曲唑辅助治疗 5 年后,绝经后妇女的总胆固醇、高密度脂蛋白胆固醇、低密度脂蛋白胆固醇显著升高,尤其是 Lp(a)升高显著。因此,此类患者在临床实践中应监测其血脂水平。

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