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一项在代谢综合征患者中与瑞舒伐他汀的对比研究:COMETS研究结果

A comparative study with rosuvastatin in subjects with metabolic syndrome: results of the COMETS study.

作者信息

Stalenhoef Anton F H, Ballantyne Christie M, Sarti Cinzia, Murin Jan, Tonstad Serena, Rose Helen, Wilpshaar Wim

机构信息

Department of Medicine, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.

出版信息

Eur Heart J. 2005 Dec;26(24):2664-72. doi: 10.1093/eurheartj/ehi482. Epub 2005 Sep 5.

Abstract

AIMS

The efficacy and safety of rosuvastatin, atorvastatin, and placebo were compared in patients with the metabolic syndrome.

METHODS AND RESULTS

Patients with the metabolic syndrome with low-density lipoprotein cholesterol (LDL-C) > or =3.36 mmol/L (130 mg/dL) and multiple risk factors conferring a 10-year coronary heart disease risk score of >10% were randomized (2:2:1) to receive rosuvastatin 10 mg, atorvastatin 10 mg, or placebo for 6 weeks. Subsequently, the rosuvastatin 10 mg and placebo groups received rosuvastatin 20 mg and the atorvastatin 10 mg group received atorvastatin 20 mg for 6 weeks. LDL-C was reduced significantly more in patients receiving rosuvastatin 10 mg when compared with those receiving atorvastatin 10 mg at 6 weeks [intention-to-treat (ITT) population by randomized treatment: 41.7 vs. 35.7%, P < 0.001; ITT population by as-allocated treatment: 42.7 vs. 36.6%, P < 0.001]. Significant LDL-C reductions were also observed in patients receiving rosuvastatin when compared with those receiving atorvastatin at 12 weeks (48.9 vs. 42.5%, P < 0.001). More patients achieved LDL-C goals with rosuvastatin when compared with atorvastatin. Rosuvastatin increased high-density lipoprotein cholesterol significantly more than atorvastatin. Treatments were well tolerated.

CONCLUSION

At equivalent doses, rosuvastatin had a significantly greater effect than atorvastatin in lowering LDL-C and improving the lipid profile and was well tolerated in patients with the metabolic syndrome.

摘要

目的

比较瑞舒伐他汀、阿托伐他汀及安慰剂在代谢综合征患者中的疗效和安全性。

方法与结果

将低密度脂蛋白胆固醇(LDL-C)≥3.36 mmol/L(130 mg/dL)且具有多个危险因素、10年冠心病风险评分>10%的代谢综合征患者按2:2:1随机分组,分别接受10 mg瑞舒伐他汀、10 mg阿托伐他汀或安慰剂治疗6周。随后,10 mg瑞舒伐他汀组和安慰剂组接受20 mg瑞舒伐他汀治疗,10 mg阿托伐他汀组接受20 mg阿托伐他汀治疗6周。在6周时,接受10 mg瑞舒伐他汀治疗的患者LDL-C降低幅度显著大于接受10 mg阿托伐他汀治疗的患者[随机治疗的意向性分析(ITT)人群:41.7%对35.7%,P<0.001;按分配治疗的ITT人群:42.7%对36.6%,P<0.001]。在12周时,接受瑞舒伐他汀治疗的患者与接受阿托伐他汀治疗的患者相比,LDL-C也有显著降低(48.9%对42.5%,P<0.001)。与阿托伐他汀相比,更多接受瑞舒伐他汀治疗的患者达到了LDL-C目标。瑞舒伐他汀使高密度脂蛋白胆固醇升高的幅度显著大于阿托伐他汀。治疗耐受性良好。

结论

在等效剂量下,瑞舒伐他汀在降低LDL-C和改善血脂谱方面的效果显著优于阿托伐他汀,且在代谢综合征患者中耐受性良好。

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