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.
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Morgan RE, Campbell SE, Yu CY, Sponseller CA, Muster HA
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.
J Cardiovasc Pharmacol. 2012 Jul;60(1):42-8. doi: 10.1097/FJC.0b013e318256cdf0.
- PubMed ID
- 22472908 [ View in PubMed]
- 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.
DrugBank Data that Cites this Article
- Drugs
- Drug Targets
Drug Target Kind Organism Pharmacological Action Actions Pitavastatin 3-hydroxy-3-methylglutaryl-coenzyme A reductase Protein Humans YesInhibitorDetails - Drug Enzymes
Drug Enzyme Kind Organism Pharmacological Action Actions Pitavastatin Cytochrome P450 2C8 Protein Humans UnknownSubstrateDetails Pitavastatin Cytochrome P450 2C9 Protein Humans UnknownSubstrateDetails Pitavastatin UDP-glucuronosyltransferase 1-3 Protein Humans UnknownSubstrateDetails Pitavastatin UDP-glucuronosyltransferase 2B7 Protein Humans UnknownSubstrateDetails - Drug Transporters
Drug Transporter Kind Organism Pharmacological Action Actions Pitavastatin ATP-binding cassette sub-family G member 2 Protein Humans UnknownSubstrateDetails Pitavastatin Canalicular multispecific organic anion transporter 1 Protein Humans UnknownSubstrateDetails Pitavastatin P-glycoprotein 1 Protein Humans UnknownSubstrateDetails Pitavastatin Sodium/bile acid cotransporter Protein Humans UnknownSubstrateDetails Pitavastatin Solute carrier organic anion transporter family member 2B1 Protein Humans UnknownSubstrateDetails