Lloret Ramon, Ycas Joseph, Stein Michael, Haffner Steven
Cardiovascular Center of South Florida, Miami, Florida, USA.
Am J Cardiol. 2006 Sep 15;98(6):768-73. doi: 10.1016/j.amjcard.2006.04.014. Epub 2006 Jul 28.
In a multicenter, open-label trial, 696 Hispanic patients with low-density lipoprotein (LDL) cholesterol levels > or =130 and < or =300 mg/dl and triglyceride levels <400 mg/dl at medium or high risk of coronary heart disease were randomized to receive 10 or 20 mg of rosuvastatin or 10 or 20 mg of atorvastatin for 6 weeks. At week 6, LDL cholesterol was decreased more by 10 mg of rosuvastatin than by 10 mg of atorvastatin (45% vs 36%, p <0.0001) and more by 20 mg of rosuvastatin than by 20 mg of atorvastatin (50% vs 42%, p <0.0001). Significantly greater decreases were also observed with rosuvastatin for total cholesterol, non-high-density lipoprotein cholesterol, apolipoprotein-B, and lipid ratios compared with milligram-equivalent doses of atorvastatin. Overall, National Cholesterol Education Program Adult Treatment Program III LDL cholesterol goals were achieved by 78% and 88% of patients who received 10 and 20 mg of rosuvastatin and by 60% and 73% of patients who received 10 and 20 mg of atorvastatin, respectively. Among high-risk patients, the LDL cholesterol goal of <100 mg/dl was achieved by 74% and 91% of patients who received 10 and 20 mg of rosuvastatin and by 52% and 62% who received 10 and 20 mg of atorvastatin, respectively. All treatments were well tolerated, and adverse events were similar in frequency across treatment groups. No cases of myopathy or rhabdomyolysis were observed. In conclusion, treatment with rosuvastatin and atorvastatin produced beneficial lipid changes in this group of Hispanic patients that appear comparable in magnitude to those observed in primarily non-Hispanic white study populations. These benefits were accompanied by a favorable safety profile that suggests no concerns particular to this population.
在一项多中心、开放标签试验中,696名患有冠心病中高危风险、低密度脂蛋白(LDL)胆固醇水平≥130且≤300mg/dl、甘油三酯水平<400mg/dl的西班牙裔患者被随机分为接受10mg或20mg瑞舒伐他汀或10mg或20mg阿托伐他汀治疗6周。在第6周时,10mg瑞舒伐他汀使LDL胆固醇降低的幅度大于10mg阿托伐他汀(45%对36%,p<0.0001),20mg瑞舒伐他汀使LDL胆固醇降低的幅度大于20mg阿托伐他汀(50%对42%,p<0.0001)。与毫克当量剂量的阿托伐他汀相比,瑞舒伐他汀在降低总胆固醇、非高密度脂蛋白胆固醇、载脂蛋白B和脂质比率方面也有显著更大的降幅。总体而言,接受10mg和20mg瑞舒伐他汀治疗的患者中分别有78%和88%达到了国家胆固醇教育计划成人治疗计划III的LDL胆固醇目标,接受10mg和20mg阿托伐他汀治疗的患者中分别有60%和73%达到了该目标。在高危患者中,接受10mg和20mg瑞舒伐他汀治疗的患者中分别有74%和91%达到了LDL胆固醇目标<100mg/dl,接受10mg和20mg阿托伐他汀治疗的患者中分别有52%和62%达到了该目标。所有治疗的耐受性良好,各治疗组的不良事件发生率相似。未观察到肌病或横纹肌溶解病例。总之,瑞舒伐他汀和阿托伐他汀治疗使这组西班牙裔患者的脂质发生了有益变化,其幅度似乎与主要为非西班牙裔白人研究人群中观察到的相当。这些益处伴随着良好的安全性,表明该人群没有特殊问题。