A subanalysis of initial LIVES data focussing on the effects of pitavastatin on HDL-C levels showed that HDL-C was elevated by 5.9 % in all patients and by 24.6 % in those with low (<l mmol/L; 40 mg/dL) HDL-C levels at baseline (P < 0.0001). A time-course analysis showed that the elevation in HDL-C in the low-HDL-C group was enhanced by 14.0 % and 24.9 % at 12 weeks and 104 weeks, respectively. In contrast, previous studies have shown that other statins have inconsistent effects on HDL-C levels, with elevations ranging from 0 % to 12 % . According to a LIVES subanalysis, pitavastatin produced a significant increase in HDL-C levels in patients switching from other statins, suggesting that patients with an unacceptably low level of HDL-C might benefit from switching to pitavastatin. Further analyses showed an improvement in HbA1c in patients with type 2 diabetes after long-term pitavastatin treatment and a significant increase in eGRF in patients with chronic kidney disease.
Results from the 5-year LIVES extension study (N = 6,582) showed that long-term treatment with pitavastatin was well tolerated and that the reduction in LDL-C achieved after 104 weeks was maintained for the duration of treatment, whereas levels of HDL-C continued to rise. Importantly, multivariate analysis of the 5-year data showed that, in addition to advanced age ($$ 65 years), male gender, hypertension, diabetes, and a history of ischemic heart disease, on-treatment levels of HDL-C and LDL-C were significant predictors for cardiovascular (CV) and cerebrovascular risk. In this study, the greatest reduction in CV and cerebrovascular risk was achieved by patients achieving both their LDL-C and HDL-C targets.
Overall, results from the LIVES study show that pitavastatin is well tolerated and effectively modifies atherogenic lipid profiles, thereby reducing CV and cerebrovascular risk in Japanese patients with hypercholesterolemia. Pitavastatin's ability to significantly and continually increase HDL-C levels over time suggests a particular benefit for patients with low baseline levels of HDL-C and/or those that fail to increase their HDL-C levels using alternative statins.