Efficacy of a low dose of pitavastatin compared with atorvastatin in primary hyperlipidemia: results of a 12-week, open label study.

BACKGROUND: Pitavastatin has a potent cholesterol-lowering action. The clinical efficacy and safety of a low dose, 1 mg, of pitavastatin were examined.

METHODS: The effect of 12 weeks' treatment with pitavastatin 1 mg in an open label, non-randomized trial involving 137 patients with hypercholesterolemia as compared with treatment with atorvastatin 10 mg.

RESULTS: Total cholesterol, low-density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol and triglyceride (TG) levels at baseline did not differ between the two groups. At follow-up, there were no significant differences in total cholesterol, LDL cholesterol and HDL cholesterol levels between the groups. The TG levels at follow-up were higher in the pitavastatin group than atorvastatin group (p < 0.01). In patients with hyperlipidemia type IIa, TG levels at follow-up were lower in the atorvastatin subgroup (p < 0.01). However, there was no significant difference in TG levels at follow-up between the two subgroups in patients with hyperlipidemia type IIb.

CONCLUSION: Pitavastatin 1 mg daily was safe and efficacious in reducing LDL cholesterol levels as compared with atorvastatin 10 mg daily. Further randomized comparative studies are needed to clarify the effect of a low dose of pitavastatin.