Hong Young Joon, Jeong Myung Ho, Bae Jang Ho, Oh Seok Kyu, Rha Seung Woon, Hur Seung Ho, Lee Sung Yun, Kim Sang Wook, Cha Kwang Soo, Chae In Ho, Ahn Tae Hoon, Kim Kee Sik
Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea.
Department of Cardiology, Konyang University Hospital, Daejeon, Korea.
Korean J Intern Med. 2017 Jul;32(4):656-667. doi: 10.3904/kjim.2016.016. Epub 2017 Jun 16.
BACKGROUND/AIMS: We evaluated the efficacy and safety and influence on glucose tolerance by different doses of pitavastatins in acute myocardial infarction (AMI) patients.
Consecutive 1,101 AMI patients who were enrolled in Livalo in Acute Myocardial Infarction Study (LAMIS)-II were randomly assigned to receive either 2 mg of pitavastatin or 4 mg of pitavastatin orally per day. Primary efficacy endpoint was composite of cardiac death, nonfatal myocardial infarction, target-lesion revascularization, and hospitalization for unstable angina, heart failure or arrhythmic events at 12-month.
There was no significant difference in primary efficacy endpoint between 2 mg and 4 mg groups (9.07% vs. 9.13%, = 0.976). The degree of the reduction of low density lipoprotein cholesterol (LDL-C) was significantly greater in 4 mg group compared to 2 mg group from baseline to follow-up (-42.05 ± 32.73 mg/dL vs. -34.23 ± 31.66 mg/dL, = 0.002). Fasting plasma glucose level was reduced significantly in both groups (-20.16 ± 54.49 mg/dL in 4 mg group and -24.45 ± 63.88 mg/dL in 2 mg group, < 0.001 and < 0.001, respectively) and there was no significant change of glycated hemoglobin in two groups from baseline to follow-up (-0.13% ± 1.21% in 4 mg group and -0.04% ± 1.10% in 2 mg group, = 0.256 and = 0.671, respectively).
Although LDL-C was reduced more significantly by using 4 mg of pitavastatin compared to 2 mg of pitavastatin, the event rate was comparable without adverse effects on glucose tolerance in both groups in AMI patients who were enrolled in LAMIS-II.
背景/目的：我们评估了不同剂量匹伐他汀对急性心肌梗死（AMI）患者的疗效、安全性及糖耐量的影响。
入选利伐沙班急性心肌梗死研究（LAMIS）-II的1101例连续AMI患者被随机分配，分别每日口服2mg匹伐他汀或4mg匹伐他汀。主要疗效终点为12个月时的心源性死亡、非致死性心肌梗死、靶病变血管重建以及因不稳定型心绞痛、心力衰竭或心律失常事件住院的复合终点。
2mg组和4mg组的主要疗效终点无显著差异（9.07%对9.13%，P = 0.976）。从基线到随访，4mg组低密度脂蛋白胆固醇（LDL-C）降低程度显著大于2mg组（-42.05±32.73mg/dL对-34.23±31.66mg/dL，P = 0.002）。两组空腹血糖水平均显著降低（4mg组为-20.16±54.49mg/dL，2mg组为-24.45±63.88mg/dL，P均<0.001），且两组糖化血红蛋白从基线到随访均无显著变化（4mg组为-0.13%±1.21%，2mg组为-0.04%±1.10%，P分别为0.256和0.671）。
在入选LAMIS-II的AMI患者中，虽然4mg匹伐他汀比2mg匹伐他汀更显著降低LDL-C，但两组事件发生率相当，且对糖耐量均无不良影响。
