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

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 hasscarcely been reported. We examined the effectiveness of therapy with pitavastatin, as theonly 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 intermediateriskgroup）were treated with pitavastatin at 2 mg daily. Serum lipids and liver enzymes, forsafety 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±45.8mg／dL to 116.9±34.9, intermediate−risk group：166.7±20.7 to 119.3±38.3；p＜0.001 forboth.）The rate of successful achievement of the serum LDL−C goal, defined by the JapanAtherosclerosis Society Guideline for the diagnosis and prevention of atherosclerotic cardiovasculardiseases for Japanese, was 64.7％ and 72.2％, in the high−risk and intermediateriskgroup, respectively. The significant reduction of serum lipid levels and high rate of successfulachievement of the serum LDL−C goal were maintained until the end of the followupperiod 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 welltoleratedduring the observation period.Conclusion Long−term therapy with pitavastatin, as the only lipid−lowering agent, is efficaciousand safe for improvement of the lipid profile, suggesting the usefulness of the drug inthe prevention of atherosclerosis and cardiovascular events.（Jpn Pharmacol Ther 2009；37：243−53）KEY WORDS Pitavastatin, Hyperlipidemia, Atherosclerosis