Prospective Study to Evaluate the Efficacy and Safety of Pitavastatin in Patients with Risk Factor of Cardiovascular Disease(PEACE Study)

ABSTRACT

BACKGROUND AND OBJECTIVES: Pitavastatin, a recently approved synthetic 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, is known to effectively treat hypercholesterolemia. The goal of this study was to investigate the efficacy and safety of pitavastatin in hyperlipidemic Korean patients with coronary risk factors. SUBJECTS AND METHODS: This was an 8-week, prospective, multicenter, open-label clinical trial. The study subjects were hyperlipidemic Korean patients (triglyceride 130 mg/dL, age; 45-75 years) with at least two coronary risk factors. After a 2-week wash out period, the eligible subjects were given 2 mg of pitavastatin once daily for 8 weeks. In the case of the patients with LDL-cholesterol > or = 100 mg/dL after the first 4 weeks of treatment, the dose of pitavastatin was increased to 4 mg per day for the remaining 4 weeks. RESULTS: Of the 131 patients initially enrolled, 105 completed the study. Among the lipid profiles, the total cholesterol, triglyceride, and LDL-cholesterol levels showed a significant reduction with mean reduction rates of -30.66%, -23.92%, and -41.06%, respectively, after 8 weeks. Interestingly, the HDL-cholesterol level was significantly increased in the subjects with a low HDL-cholesterol level (HDL-cholesterol < 40 mg/dL) after 8 weeks of therapy (35.28+/-4.38 mg/dL to 40.39+/-6.45 mg/dL, 15.9%, p=0.001). The proportions of patients who achieved the LDL-cholesterol goal of the National Cholesterol Education Program Adult Treatment Panel III were 72.5% (37/51), 93.6% (44/47), and 100.0% (7/7) for the patients with goals of 100 mg/dL, 130 mg/dL, and 160 mg/dL, respectively. Five patients had mild adverse drug events, such as fatigue, itching, myalgia, and anorexia. No significant abnormalities were detected in the laboratory tests, including the liver function test and creatinine kinase level. CONCLUSION: The HMG-CoA reductase inhibitor, pitavastatin, was highly effective and generally well tolerated with an acceptable safety profile in hyperlipidemic Korean patients with coronary risk factors.