Key result
Pitavastatin 4 mg did not significantly reduce the 12-month incidence of major adverse cardiovascular events compared to pitavastatin 2 mg in patients with acute myocardial infarction (9.13% vs. 9.07%, OR 0.993, p=0.976).
Why the study?
Does pitavastatin 4 mg reduce the composite of cardiac death, nonfatal myocardial infarction, target-lesion revascularization, and hospitalization for unstable angina, heart failure or arrhythmic events compared to pitavastatin 2 mg in patients with acute myocardial infarction?
RCT (n=1,101)
Randomly assigned
Yes
Does pitavastatin 4 mg reduce the composite of cardiac death, nonfatal myocardial infarction, target-lesion revascularization, and hospitalization for unstable angina, heart failure or arrhythmic events compared to pitavastatin 2 mg in patients with acute myocardial infarction?
High-dose pitavastatin (4 mg) provides greater LDL-C reduction than standard-dose (2 mg) without increasing adverse events or worsening glucose tolerance, though it did not significantly reduce 12-month clinical events in AMI patients.
Answers are grounded in this paper and cite their sources.
Comparable event rates with 2 mg versus 4 mg pitavastatin in AMI support either dose; leaves open optimal selection for LDL goals.
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.
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Hong et al. (2017) conducted an RCT in Acute myocardial infarction (n=1,101). Pitavastatin vs. Pitavastatin 2 mg daily was evaluated on Composite of cardiac death, nonfatal myocardial infarction, target-lesion revascularization, and hospitalization for unstable angina, heart failure or arrhythmic events at 12-month (TLR-MACE) (OR 0.993, p=0.976). Pitavastatin 4 mg did not significantly reduce the 12-month incidence of major adverse cardiovascular events compared to pitavastatin 2 mg in patients with acute myocardial infarction (9.13% vs. 9.07%, OR 0.993, p=0.976).
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