A large-scale, long-term, prospective post-marketing surveillance study of pitavastatin（LIVALO^® Tablet）, an HMG-CoA reductase inhibitor, was conducted by prospective recruitment of patients by central registration. Of the 20279 patients recruited, 19925 patients were analyzed for drug safety and 18031 patients analyzed for effectiveness. The outcome of the single-arm uncontrolled observational study is summarized below：
　　1）Adverse drug reactions were observed in 2069 out of the 19925 patients（10.4％）, and almost all of the adverse drug reactions were classified as mild.
　　2）Common adverse drug reactions were blood creatine phosphokinase increased（2.74％）, alanine aminotransferase increased（1.79％）, aspartate aminotransferase increased（1.50％）, myalgia（1.08％）and gamma-glutamyltransferase increased（1.00％）.
　　3）Treatment with this drug resulted in significant reductions of serum LDL-cholesterol（LDL-C）（29.1％）. The peak serum lipid level reduction occurred within 4 weeks of treatment initiation, and then remained at the same level. In data from patients who had baseline abnormal levels of triglyceride（TG）and HDL-cholesterol（HDL-C）, pitavastatin decreased TG（22.7％）, and increased the HDL-C（19.9％）from the baseline.
　　4）By criteria established in the Japan Atherosclerosis Society（JAS）guideline for diagnosis and prevention of atherosclerotic cardiovascular diseases for Japanese, 88.2％ of the primary prevention low-risk patients achieved a goal of LDL-C level, 82.7％ of intermediate-risk patients, 66.5％ of high-risk patients and 50.3％ of secondary prevention patients.
　　No significant safety or effectiveness issues were observed. These safety and effectiveness results reflect similar findings to the studies performed to support the Japan New Drug Application. Pitavastatin is an effective and safe drug for the indication of hypercholesterolemia.