Stalenhoef Anton F H, Ballantyne Christie M, Sarti Cinzia, Murin Jan, Tonstad Serena, Rose Helen, Wilpshaar Wim
Department of Medicine, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands.
Eur Heart J. 2005 Dec;26(24):2664-72. doi: 10.1093/eurheartj/ehi482. Epub 2005 Sep 5.
The efficacy and safety of rosuvastatin, atorvastatin, and placebo were compared in patients with the metabolic syndrome.
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.
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.
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。
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。
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。