Effects of Pitavastatin (LIVALO Tablet) on High Density Lipoprotein Cholesterol (HDL-C) in Hypercholesterolemia-Sub-Analysis of LIVALO Effectiveness and Safety (LIVES) Study

Background: Low high-density lipoprotein cholesterol (HDL-C) is an important clinical risk factor for cardiovascular disease (CVD). Statins have been known to have a potent HDL-C-elevating effect in addition to low-density lipoprotein cholesterol (LDL-C)-lowering effects. Methods: The database of LIVALO effectiveness and safety (LIVES) Study, a large-scale (n=20,279), long-term (104 weeks), prospective post-marketing surveillance of hypercholesterolemic patients treated with pitavastatin, was used to evaluate and analyze effects on plasma lipids, especially focusing on HDL-C. Results: Total cholesterol (TC) (-21.0%) and LDL-C (-31.3%) were significantly reduced. The decrease in triglyceride (TG) was significant in hypertriglyceridemic patients. HDL-C was elevated by 5.9% and 24.6% in all and in patients with low HDL-C levels (less than 40 mg/dL) at baseline, respectively (p < 0.0001). In time-course analysis, elevation of HDL-C in the low HDL-C group was enhanced by 14.0% and 24.9% at 12 weeks and 104 weeks, respectively. A significant increase in HDL-C by pitavastatin treatment was also observed after switching from other statins. Multivariable analysis showed that BMI, diabetes, liver disease, and pre-treated other cholesterol-lowering drugs emerged as significant factors influencing HDL-C. Conclusions: Pitavastatin had stable clinical effects on LDL-C, TG, and HDL-C for 104 weeks. It was noteworthy that HDL-C in patients with low HDL-C was continuously increased by this agent during the period tested.