Department of Internal Medicine, Yeungnam University Medical Cencer, Daegu, Korea.
Korean J Intern Med. 2010 Mar;25(1):27-35. doi: 10.3904/kjim.2010.25.1.27. Epub 2010 Feb 26.
BACKGROUND/AIMS: This multicenter, open-labeled, randomized trial was performed to compare the effects of rosuvastatin 10 mg and atorvastatin 10 mg on lipid and glycemic control in Korean patients with nondiabetic metabolic syndrome.
In total, 351 patients who met the modified National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria for metabolic syndrome with low-density lipoprotein cholesterol (LDL-C) levels > or = 130 mg/dL were randomized to receive either rosuvastatin 10 mg (n = 173) or atorvastatin 10 mg (n = 178) for over 6 weeks.
After 6 weeks of treatment, greater reductions in total cholesterol (- 35.94 +/- 11.38 vs. - 30.07 +/- 10.46%, p < 0.001), LDL-C (48.04 +/- 14.45 vs. 39.52 +/- 14.42%, p < 0.001), non-high-density lipoprotein cholesterol (- 42.93 +/- 13.15 vs. - 35.52 +/- 11.76%, p < 0.001), and apolipoprotein-B (- 38.7 +/- 18.85 vs. - 32.57 +/- 17.56%, p = 0.002) levels were observed in the rosuvastatin group as compared to the atorvastatin group. Overall, the percentage of patients attaining the NCEP ATP III goal was higher with rosuvastatin as compared to atorvastatin (87.64 vs. 69.88%, p < 0.001). Changes in glucose and insulin levels, and homeostasis model assessment of insulin resistance index were not significantly different between the two groups. The safety and tolerability of the two agents were similar.
Rosuvastatin 10 mg was more effective than atorvastatin 10 mg in achieving NCEP ATP III LDL-C goals in patients with nondiabetic metabolic syndrome, especially in those with lower NCEP ATP III target level goals.
背景/目的:本多中心、开放性、随机试验旨在比较瑞舒伐他汀 10mg 和阿托伐他汀 10mg 对非糖尿病代谢综合征韩国患者的血脂和血糖控制的影响。
共有 351 名符合改良后的美国国家胆固醇教育计划成人治疗专家组第三版(NCEP ATP III)代谢综合征标准且低密度脂蛋白胆固醇(LDL-C)水平≥130mg/dL 的患者,被随机分为瑞舒伐他汀 10mg 组(n=173)或阿托伐他汀 10mg 组(n=178),分别接受 6 周的治疗。
治疗 6 周后,瑞舒伐他汀组总胆固醇(-35.94±11.38% vs. -30.07±10.46%,p<0.001)、LDL-C(-48.04±14.45% vs. -39.52±14.42%,p<0.001)、非高密度脂蛋白胆固醇(-42.93±13.15% vs. -35.52±11.76%,p<0.001)和载脂蛋白 B(-38.7±18.85% vs. -32.57±17.56%,p=0.002)水平的降低幅度明显大于阿托伐他汀组。总体而言,瑞舒伐他汀组达到 NCEP ATP III 目标的患者比例明显高于阿托伐他汀组(87.64% vs. 69.88%,p<0.001)。两组间血糖和胰岛素水平的变化以及胰岛素抵抗指数的稳态模型评估无显著差异。两种药物的安全性和耐受性相似。
在非糖尿病代谢综合征患者中,瑞舒伐他汀 10mg 比阿托伐他汀 10mg 更能有效达到 NCEP ATP III 的 LDL-C 目标,尤其是在 NCEP ATP III 目标水平较低的患者中。