A large-scale survey on cardio-cerebrovascular events during pitavastatin (LIVALO tablet) therapy in Japanese patients with hypercholesterolemia - LIVALO effectiveness and safety study extension (LIVES study extension)

Background: Currently, statins with potent effects on lowering LDL-C are predominantly used in the treatment of hypercholesterolemia in Japan. To date however, no studies have examined the effects of potent statins on cardiovascular and cerebrovascular events in Japanese patients. Objectives: This study aimed at evaluating the long-term effects of pitavastatin (a potent statin) on cardiovascular and cerebrovascular events. Methods: Hypercholesterolemia patients were enrolled in the LIVALO Effectiveness and Safety Study (LIVES Study) and followed for 2 years while they were treated with pitavastatin at doses of 1, 2, or 4 mg/day. Those who consented to participate in the present study (LIVES Study Extension) were evaluated for an additional 3 years (5 years in total from the start of the LIVES Study). Cardiovascular events, cerebrovascular events, and sudden death during the pitavastatin- treatment period in these patients were studied. Results: A total 6582 patients enrolled into the study. Pooled analysis of pitavastatin treatment, demonstrated LDL-C levels significantly decreased by 30.5%. HDL-C levels significantly increased by 5.7%, notably with an increase of 28.9% in patients with low HDL-C levels (<40 mg/dL) at baseline. The cumulative incidence of total cardiovascular events in the group achieving the LDL-C control goals, as defined in the Japan Atherosclerosis Society (JAS) Guidelines, was significantly lower than that in the group not achieving the goals (hazard ratio, 0.43 ; 95% confidence interval, 0.32-0.59 ; p<0.0001). In addition, the cumulative incidence of total events in the group achieving the HDL-C control goal was significantly lower (hazard ratio, 0.41 ; 95% confidence interval, 0.28-0.62 ; p<0.0001). Conclusions: These results from the LIVES Study Extension indicate that it is essential to control both LDL-C and HDL-C at levels recommended as treatment goals in the relevant Guidelines for the suppression of the onset of cardiovascular and cerebrovascular events in patients with hypercholesterolemia during treatment with pitavastatin.