Evaluation of the Clinical Efficacy of Continuous Pitavastatin Treatment for 36 months in Patients with Hypercholesterolemia

摘要

Background and objectives Pitavastatin, a 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin), is known as a potent cholesterol-lowering action. However, the efficacy and safety of long-term use of the drug for more than 2 years has scarcely been reported. We examined the effectiveness of therapy with pitavastatin, as the only lipid-lowering agent, administered for 36 months.Methods A total of 35 patients with hyperlipidemia (male : female. 21 : 14 ; age, 61.3 ± 12.9 years old ; 17 patients in the cardiovascular high-risk group and 18 in the intermediate-risk group) were treated with pitavastatin at 2 mg daily. Serum lipids and liver enzymes, for safety evaluation, were assessed during and after 36 months' pitavastatin treatment. Results Significant reduction of the serum LDL-C levels was observed after 6 months' therapy in both the high-risk and intermediate-risk groups (high-risk group : 162.3+45.8 mg/dL to 116.9+34.9, intermediate-risk group : 166.7(+-)20.7 to 119.3(+-)38.3 ;P< 0.001 for both.) The rate of successful achievement of the serum LDL-C goal, defined by the Japan Atherosclerosis Society Guideline for the diagnosis and prevention of atherosclerotic cardiovascular diseases for Japanese, was 64.7% and 72.2%, in the high-risk and intermediate-risk group, respectively. The significant reduction of serum lipid levels and high rate of successful achievement of the serum LDL-C goal were maintained until the end of the follow-up period of 36 months. The LDL/HDL ratio reduced by 33.2% and 31.3% from the baseline, and the serum non-HDL-C levels also decreased by 29.8% and 30.1% from the baseline, in the high-risk group and intermediate-risk group, respectively. Pitavastatin was well-tolerated during the observation period.Conclusion Long-term therapy with pitavastatin, as the only lipid-lowering agent, is efficacious and safe for improvement of the lipid profile, suggesting the usefulness of the drug in the prevention of atherosclerosis and cardiovascular events.