NEW YORK (Reuters Health) – More than two-thirds of patients prescribed pitavastatin after an acute MI achieve target LDL cholesterol levels, and clinical outcomes are generally favorable, according to a report from Korea appearing in a September 7th online issue of the American Journal of Cardiology.

Dr. Seung-Woon Rha, at Korea University Guro Hospital in Seoul, and colleagues say the HMG-coA reductase inhibitor pitavastatin (Livalo) is widely used in Asia. A news release issued by Kowa Pharmaceuticals America, Inc. indicated that the drug was approved by the US Food and Drug Administration in August 2009 for the treatment of primary hypercholesterolemia and combined dyslipidemias.

In the current study, the authors report on 12-month outcomes in 1039 consecutive MI patients seen at 10 centers in Korea who were routinely administered 2 mg/d pitavastatin from the time of presentation.

Mean total cholesterol dropped from 191 to 154 mg/dL in the first month, and LDL cholesterol declined from 122 to 88 mg/dL, the investigators found. These changes were sustained over 12 months follow-up.

“In addition, 70.5% of patients had achieved the LDL cholesterol target defined by National Cholesterol Education Program criteria,” they report. However, this was based on only 319 of the 1039 patients “because of missing laboratory test results.”

Furthermore, a “remarkably high” mean C-reactive protein level of 10.0 mg/dL at baseline declined to 2.3 mg/dL during the first month and stayed down for the 12-month period.

As for safety, 318 adverse events occurred in 220 patients, although just 20 events in 14 patients were considered to be related to treatment, the findings indicate. “Common adverse treatment-related adverse events were 4 cases of serum glutamic oxaloacetic transaminase/glutamic pyruvic transaminase increase, 3 cases of myalgia, and 1 case of creatinine phosphokinase increase,” according to the report.

There were no instances of myopathy, myositis, or rhabdomyolysis, the authors note.

The all-cause mortality rate during follow-up was 3.5%, recurrent MIs occurred in 1.6%, and the rate of target lesion revascularization was 4.7%, Dr. Rha and colleagues report. “We assume that this favorable 1-year cumulative clinical outcome is closely associated with pitavastatin as the sole statin in patients with AMI,” they conclude.

However, they note that this was a nonrandomized, single-arm observational study and “a randomized trial would be required to truly provide more relevant scientific data.”

The paper includes a disclosure statement: “All participating centers received an unrestricted research grant from JW Pharmaceutical, Seoul, Korea.”

Reference:
Long-Term Safety and Efficacy of Pitavastatin in Patients With Acute Myocardial Infarction (from the Livalo Acute Myocardial Infarction Study [LAMIS])
Am J Cardiol 2011.