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低剂量阿托伐他汀和瑞舒伐他汀对血浆脂质谱的影响:一项针对原发性高胆固醇血症患者的长期、随机、开放标签研究。

Effects of low-dose atorvastatin and rosuvastatin on plasma lipid profiles: a long-term, randomized, open-label study in patients with primary hypercholesterolemia.

作者信息

Mazza Fabio, Stefanutti Claudia, Di Giacomo Serafina, Vivenzio Antonio, Fraone Nadia, Mazzarella Bruno, Bucci Antonello

机构信息

Department of Clinical and Medical Therapy, University of Rome La Sapienza, Umberto I Hospital, Rome, Italy.

出版信息

Am J Cardiovasc Drugs. 2008;8(4):265-70. doi: 10.2165/00129784-200808040-00006.

Abstract

BACKGROUND AND OBJECTIVE

Despite the favorable effects of reduction of low-density lipoprotein-cholesterol (LDL-C) levels in decreasing the risk of coronary heart disease, many patients treated with lipid-lowering HMG-CoA reductase inhibitors (statins) do not achieve goal LDL-C levels. This may be due to high doses of statins prescribed that could potentially induce adverse effects and compromise patient safety and compliance with considerable expense in the long-term. We compared the actions of rosuvastatin and atorvastatin, administered at the low dosages of 10 and 20 mg/day, respectively, in reducing plasma LDL-C levels and their effects on other components of the atherogenic lipid profile in patients with primary hypercholesterolemia.

METHODS

In this randomized, parallel group, open-label clinical study, 106 patients with LDL-C >200 mg/dL were treated with rosuvastatin 10 mg/day (group A; n = 52), or atorvastatin 20 mg/day (group B; n = 54) for 48 weeks.

RESULTS

At 48 weeks, rosuvastatin 10 mg/day was associated with a significantly greater reduction in plasma LDL-C levels compared with atorvastatin 20 mg/day (-44.32% vs -30%; p < 0.005). Compared with atorvastatin, rosuvastatin also produced a greater reduction in plasma total cholesterol, triglycerides, and non-high-density lipoprotein-cholesterol (non-HDL-C) levels (p < 0.005). Plasma HDL-C levels were not affected significantly, independent of the drug used.

CONCLUSION

In high-risk patients with primary hypercholesterolemia, rosuvastatin 10 mg/day was more efficacious than atorvastatin 20 mg/day in reducing plasma LDL-C levels, enabling goal LDL-C levels to be achieved and improving other lipid parameters. Both treatments were well tolerated over 48 weeks.

摘要

背景与目的

尽管降低低密度脂蛋白胆固醇(LDL-C)水平在降低冠心病风险方面具有积极作用,但许多接受降脂HMG-CoA还原酶抑制剂(他汀类药物)治疗的患者并未达到LDL-C目标水平。这可能是由于所开他汀类药物剂量较高,可能会引发不良反应,并在长期内影响患者安全性和依从性,且费用高昂。我们比较了瑞舒伐他汀和阿托伐他汀分别以10毫克/天和20毫克/天的低剂量给药时,对原发性高胆固醇血症患者降低血浆LDL-C水平的作用及其对致动脉粥样硬化血脂谱其他成分的影响。

方法

在这项随机、平行组、开放标签的临床研究中,106例LDL-C>200毫克/分升的患者接受瑞舒伐他汀10毫克/天治疗(A组;n = 52),或阿托伐他汀20毫克/天治疗(B组;n = 54),为期48周。

结果

在48周时,与阿托伐他汀20毫克/天相比,瑞舒伐他汀10毫克/天使血浆LDL-C水平降低幅度显著更大(-44.32%对-30%;p<0.005)。与阿托伐他汀相比,瑞舒伐他汀还使血浆总胆固醇、甘油三酯和非高密度脂蛋白胆固醇(非HDL-C)水平降低幅度更大(p<0.005)。血浆HDL-C水平不受所用药物影响,差异无统计学意义。

结论

在原发性高胆固醇血症高危患者中,瑞舒伐他汀10毫克/天在降低血浆LDL-C水平方面比阿托伐他汀20毫克/天更有效,能够实现LDL-C目标水平并改善其他血脂参数。两种治疗在48周内耐受性均良好。

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