一项双盲、双模拟、随机、安慰剂对照试验，旨在评估他汀类药物治疗对墨西哥高甘油三酯血症患者甘油三酯水平的影响。
A double-blind, double-dummy, randomized, placebo-controlled trial to evaluate the effect of statin therapy on triglyceride levels in Mexican hypertriglyceridemic patients.
机构信息
Clinical Research Training Center, National Medical Center, XXI Century, Social Security Mexican Institute, F.D., Mexico.
出版信息
Curr Med Res Opin. 2013 Apr;29(4):379-86. doi: 10.1185/03007995.2013.766590. Epub 2013 Feb 21.
OBJECTIVE
The most prevalent dyslipidemias in Mexico are low high-density lipoprotein (HDL) and high triglyceride (TG) levels. Hypertriglyceridemia (HTG) has been considered an independent risk factor for cardiovascular disease (CVD). The aim of this study was to evaluate the efficacy of rosuvastatin (RSV) in reducing TG levels in Mexican patients.
METHODS
A randomized, double-blind, double-dummy, parallel-group, placebo-controlled, multicenter, phase IV study was conducted. Patients were of both genders, ≥ 18 years old, with basal TG levels between 200 and 800 mg/dl, LDL levels ≤ 190 mg/dl. Patients were randomized to receive rosuvastatin 10 mg (Group 1), 20 mg (Group 2) or placebo (Group 3) once daily for 8 weeks. Primary efficacy was TG level; secondary efficacy was non-HDL; HDL, low-density lipoprotein (LDL), total cholesterol (TC), Apo (apolipoprotein) A1, and ApoB. Safety data were evaluated up to 30 days after the last dose of medication. The Mann-Whitney U-test was performed to contrast each RSV groups against placebo; p < 0.05 was considered significant. Trial registry number is NCT00473655.
RESULTS
A total of 334 patients were randomized: Group 1 = 111, Group 2 = 112, and Group 3 = 111. Basal TG median value levels were 278 mg/dl, 266 mg/dl, 279 mg/dl with median reduction (MdR) at 8 weeks of 26.6%, 32.19% and 7.58%, respectively, (Group 1 vs. Group 3 p = 0.002, and Group 2 vs. Group 3 p < 0.0001). Basal non-HDL values were 179 mg/dl, 180 mg/dl and 179 mg/dl with a MdR of 27%, 32% and 8%, respectively (Group 1 vs. Group 3 p < 0.0001, and Group 2 vs. Group 3 p < 0.0001); basal LDL vales were 130 mg/dl, 130 mg/dl and 127 mg/dl with MdR 35%, 44% and -4% (Group 1 vs. Group 3 p < 0.0001, Group 2 vs. Group 3 p < 0.0001); basal ApoB values were 114 mg/dl, 115 mg/dl and 110.5 mg/dl with MdR 25%, 33% and -0.5% (Group 1 vs. Group 3 p < 0.0001, Group 2 vs. Group 3 p < 0.001).
CONCLUSION
Rosuvastatin 10 and 20 mg/day significantly reduced triglycerides and improved atherogenic lipid profile in HTG Mexican patients. The main limitation was the short follow-up time period.
目的
墨西哥最常见的血脂异常是低高密度脂蛋白（HDL）和高甘油三酯（TG）水平。高甘油三酯血症（HTG）已被认为是心血管疾病（CVD）的独立危险因素。本研究旨在评估罗苏伐他汀（RSV）降低墨西哥患者 TG 水平的疗效。
方法
进行了一项随机、双盲、双模拟、平行组、安慰剂对照、多中心、四期研究。患者为男女，年龄≥18 岁，基础 TG 水平在 200 至 800mg/dl 之间，LDL 水平≤190mg/dl。患者随机接受罗苏伐他汀 10mg（第 1 组）、20mg（第 2 组）或安慰剂（第 3 组），每日一次，持续 8 周。主要疗效为 TG 水平；次要疗效为非-HDL；HDL、低密度脂蛋白（LDL）、总胆固醇（TC）、载脂蛋白（Apo）A1 和 ApoB。安全性数据评估至最后一次服药后 30 天。采用曼-惠特尼 U 检验比较每组 RSV 与安慰剂的差异；p<0.05 为差异有统计学意义。试验注册号为 NCT00473655。
结果
共随机分配了 334 名患者：第 1 组=111 名，第 2 组=112 名，第 3 组=111 名。基础 TG 中位数水平分别为 278mg/dl、266mg/dl 和 279mg/dl，8 周时的中位数降低（MdR）分别为 26.6%、32.19%和 7.58%（第 1 组与第 3 组 p=0.002，第 2 组与第 3 组 p<0.0001）。基础非-HDL 值分别为 179mg/dl、180mg/dl 和 179mg/dl，MdR 分别为 27%、32%和 8%（第 1 组与第 3 组 p<0.0001，第 2 组与第 3 组 p<0.0001）；基础 LDL 值分别为 130mg/dl、130mg/dl 和 127mg/dl，MdR 分别为 35%、44%和-4%（第 1 组与第 3 组 p<0.0001，第 2 组与第 3 组 p<0.0001）；基础 ApoB 值分别为 114mg/dl、115mg/dl 和 110.5mg/dl，MdR 分别为 25%、33%和-0.5%（第 1 组与第 3 组 p<0.0001，第 2 组与第 3 组 p<0.001）。
结论
罗苏伐他汀 10mg 和 20mg/天可显著降低 HTG 墨西哥患者的甘油三酯水平，并改善致动脉粥样硬化性血脂谱。主要限制是随访时间短。
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