Efficacy and safety of pitavastatins in patients with acute myocardial infarction: Livalo in Acute Myocardial Infarction Study (LAMIS) II.

BACKGROUND/AIMS: We evaluated the efficacy and safety and influence on glucose tolerance by different doses of pitavastatins in acute myocardial infarction (AMI) patients.

METHODS

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.

RESULTS

There was no significant difference in primary efficacy endpoint between 2 mg and 4 mg groups (9.07% vs. 9.13%, p = 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, p = 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, p < 0.001 and p < 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, p = 0.256 and p = 0.671, respectively).

CONCLUSIONS

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.