Mazza Fabio, Stefanutti Claudia, Di Giacomo Serafina, Vivenzio Antonio, Fraone Nadia, Mazzarella Bruno, Bucci Antonello
Department of Clinical and Medical Therapy, University of Rome La Sapienza, Umberto I Hospital, Rome, Italy.
Am J Cardiovasc Drugs. 2008;8(4):265-70. doi: 10.2165/00129784-200808040-00006.
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.
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.
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.
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.
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。
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。
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。
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。