title: Comparison of the safety, tolerability, and pharmacokinetic profile of a single oral dose of pitavastatin 4 mg in adult subjects with severe renal impairment not on hemodialysis versus healthy adult subjects.
abstract: Pitavastatin is a novel statin recently approved in the United States as an adjunctive therapy with diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, and triglycerides and to increase high-density lipoprotein cholesterol. 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 of 15-29 mL/min/1.73 m2) and group B: 8 healthy adult subjects (estimated glomerular filtration rate ≥80 mL/min/1.73 m2). On day 1, the subjects received a single oral dose of pitavastatin 4 mg and remained in the clinic on days 1-3 for safety and pharmacokinetic assessments. Comparing group A with group B, the geometric mean ratio of AUC(0-inf) for pitavastatin was 1.36 (90% confidence interval, 0.88-2.11). For Cmax, the corresponding ratio was 1.18 (90% confidence interval, 0.68-2.02). There were no severe treatment-emergent adverse events (AEs), serious AEs, deaths, or treatment-emergent AEs leading to study drug discontinuation. 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.
authors.affiliation: Kowa Research Institute, Inc, Morrisville, NC 27560, USA. rmorgan@kowaus.com
authors.forename: Roger E
authors.initials: RE
authors.lastname: Morgan
authors.forename: Stuart E
authors.initials: SE
authors.lastname: Campbell
authors.forename: Christine Y
authors.initials: CY
authors.lastname: Yu
authors.forename: Craig A
authors.initials: CA
authors.lastname: Sponseller
authors.forename: Heather A
authors.initials: HA
authors.lastname: Muster
mesh_terms: D000328:Adult; D000368:Aged; D019540:Area Under Curve; D016022:Case-Control Studies; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects* / Q000493:pharmacokinetics; D008297:Male; D008875:Middle Aged; D011804:Quinolines / Q000009:adverse effects* / Q000493:pharmacokinetics; D051437:Renal Insufficiency / Q000503:physiopathology*; D012720:Severity of Illness Index
chemical_list: D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D011804:Quinolines; C108475:pitavastatin