Safety and efficacy of pitavastatin in patients with hypercholesterolemia: a multicenter study

To evaluate the safety and efficacy of pitavastatin in patients with hypercholesterolemia in China under conditions of extensive usage. This was a 12-week, multicenter, open-label, without parallel-group comparison, phase IV clinical trial. There were 427 subjects in the safety set. The adverse events mainly included vomiting, myalgia and the elevations of aspartate transaminase (AST), alanine transaminase (ALT) and creatine kinase (CK), etc. The incidence of drug-related adverse events was 4.22%. There were no significant differences between pre-exposure and post-exposure average levels of renal function indicators and blood routine examination item (all P > 0.05). None of them had a high AST/ALT value, i.e. > 3 times upper limits of normal (ULN), or had a high CK value, i.e. > 10 times ULN. There were 397 subjects in the per protocol set. At week 12 post-treatment, the blood levels of total cholesterol and low density lipoprotein cholesterol (LDL-C) in subjects without previous treatment decreased 24.6% and