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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.
MedLine Citation:
PMID:  22472908     Owner:  NLM     Status:  Publisher    
ABSTRACT: 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 m) and Group B: 8 healthy adult subjects, (eGFR ≥80 mL/min/1.73 m). 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. 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.
Roger E Morgan; Stuart E Campbell; Christine Y Yu; Craig A Sponseller; Heather A Muster
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-4-2
Journal Detail:
Title:  Journal of cardiovascular pharmacology     Volume:  -     ISSN:  1533-4023     ISO Abbreviation:  -     Publication Date:  2012 Apr 
Date Detail:
Created Date:  2012-4-4     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  7902492     Medline TA:  J Cardiovasc Pharmacol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
*Kowa Research Institute, Inc., Morrisville, NC, USA †Eli Lilly and Company, Indianapolis, IN, USA ‡DaVita Clinical Research, Minneapolis, MN, USA.
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