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ω-3 酸乙酯处方药与阿托伐他汀联合应用对混合性血脂异常患者循环脂蛋白颗粒、载脂蛋白 CIII 和脂蛋白相关磷脂酶 A2 质量的影响。

Effects of prescription omega-3-acid ethyl esters, coadministered with atorvastatin, on circulating levels of lipoprotein particles, apolipoprotein CIII, and lipoprotein-associated phospholipase A2 mass in men and women with mixed dyslipidemia.

机构信息

Provident Clinical Research, Biofortis North America, Glen Ellyn, IL 60137, USA.

出版信息

J Clin Lipidol. 2011 Nov-Dec;5(6):483-92. doi: 10.1016/j.jacl.2011.09.001. Epub 2011 Sep 13.

Abstract

BACKGROUND

Prescription omega-3-acid ethyl esters (POM3) reduce triglycerides (TG) and very low-density lipoprotein cholesterol and increase high-density lipoprotein cholesterol (HDL-C) in patients with hypertriglyceridemia.

OBJECTIVE

To examine the effects of POM3 plus atorvastatin versus placebo plus atorvastatin on lipoprotein particle concentrations and sizes, apolipoprotein (Apo) CIII, and lipoprotein-associated phospholipase A(2) mass in subjects with mixed dyslipidemia.

METHODS

After a 4-week diet lead in, men and women with non-HDL-C >160 mg/dL and TG 250-599 mg/dL, while taking no lipid-altering drugs, received double-blind 4 g/d POM3 (n = 118) or placebo (n = 119) with open-label atorvastatin 10 mg/d for 8 weeks, followed by escalation to 20 mg/d atorvastatin for 4 weeks, then 40 mg/d atorvastatin for 4 weeks.

RESULTS

Total low-density lipoprotein particle (LDL-P) concentration decreased significantly from baseline, and the reductions did not differ between the POM3 and placebo groups (-659.7 vs -624.4 nmol/L, P = .181). With POM3, compared with placebo, small LDL-P concentration decreased (P = .026), large LDL-P concentration increased (P < .001), mean LDL-P size increased (P = .001), a larger fraction of subjects switched from LDL subclass pattern B to A, and Apo CIII and lipoprotein-associated phospholipase A(2) levels were reduced (P < .001). The incremental effects of POM3 were similar across atorvastatin doses for most variables.

CONCLUSION

This analysis supports the view that LDL-P concentration is not increased by POM3 plus atorvastatin, relative to atorvastatin monotherapy, and is associated with potentially favorable shifts in LDL-P subfractions, Apo CIII and lipoprotein-associated phospholipase A(2) in mixed dyslipidemia.

摘要

背景

处方 ω-3 酸乙酯(POM3)可降低高甘油三酯血症患者的甘油三酯(TG)和极低密度脂蛋白胆固醇,并增加高密度脂蛋白胆固醇(HDL-C)。

目的

研究 POM3 加阿托伐他汀与安慰剂加阿托伐他汀对混合性血脂异常患者脂蛋白颗粒浓度和大小、载脂蛋白(Apo)CIII 和脂蛋白相关磷脂酶 A(2)质量的影响。

方法

在 4 周的饮食引导后,非高密度脂蛋白胆固醇(非 HDL-C)>160mg/dL 且 TG 250-599mg/dL 的男性和女性,在未服用任何调脂药物的情况下,接受为期 8 周的每日 4g POM3(n=118)或安慰剂(n=119)的双盲治疗,同时服用开放标签阿托伐他汀 10mg/d,4 周后增至阿托伐他汀 20mg/d,再增至阿托伐他汀 40mg/d 4 周。

结果

总低密度脂蛋白颗粒(LDL-P)浓度从基线显著降低,POM3 组和安慰剂组的降低幅度无差异(-659.7 对-624.4nmol/L,P=0.181)。与安慰剂相比,POM3 使小 LDL-P 浓度降低(P=0.026),大 LDL-P 浓度升高(P<0.001),平均 LDL-P 大小增加(P=0.001),更多的受试者从 LDL 亚类模式 B 转变为 A,Apo CIII 和脂蛋白相关磷脂酶 A(2)水平降低(P<0.001)。在大多数变量中,POM3 的增量作用在阿托伐他汀剂量上是相似的。

结论

这项分析支持这样一种观点,即与阿托伐他汀单药治疗相比,POM3 加阿托伐他汀不会增加 LDL-P 浓度,并与混合性血脂异常中 LDL-P 亚组分、Apo CIII 和脂蛋白相关磷脂酶 A(2)的潜在有利变化相关。

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