Morgan RE et al. – A single dose of pitavastatin 4 mg was safe and well tolerated by the subjects in this study with severe renal impairment who were not on hemodialysis.

• Pitavastatin is a novel statin recently approved in the United States as an adjunctive therapy with diet to reduce elevated total cholesterol (TC), low–density lipoprotein cholesterol (LDL–C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase high–density lipoprotein cholesterol (HDL–C).
• This open–label study enrolled 16 subjects as follows:
• Group A: 8 adult subjects with severe renal impairment who were not on hemodialysis (estimated glomerular filtration rate [eGFR] of 15 to 29 mL/min/1.73 m2)
• And group B: 8 healthy adult subjects, (eGFR >=80 mL/min/1.73 m2).
• On Day 1, subjects received a single oral dose of pitavastatin 4 mg and remained in the clinic on Days 1, 2, and 3 for safety and pharmacokinetic assessments.

• Comparing Group A with Group B, the geometric mean ratio of AUC0–inf for pitavastatin was 1.36 (90% confidence interval [CI], 0.88 to 2.11).
• For Cmax, the corresponding ratio was 1.18 (90% CI, 0.68 to 2.02).
• There were no severe treatment–emergent adverse events (AEs), serious AEs, deaths, or treatment–emergent AEs leading to study drug discontinuation.