PMID- 22472908
OWN - NLM
STAT- MEDLINE
DCOM- 20121228
LR  - 20120709
IS  - 1533-4023 (Electronic)
IS  - 0160-2446 (Linking)
VI  - 60
IP  - 1
DP  - 2012 Jul
TI  - 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.
PG  - 42-8
LID - 10.1097/FJC.0b013e318256cdf0 [doi]
AB  - 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.
FAU - Morgan, Roger E
AU  - Morgan RE
AD  - Kowa Research Institute, Inc, Morrisville, NC 27560, USA. rmorgan@kowaus.com
FAU - Campbell, Stuart E
AU  - Campbell SE
FAU - Yu, Christine Y
AU  - Yu CY
FAU - Sponseller, Craig A
AU  - Sponseller CA
FAU - Muster, Heather A
AU  - Muster HA
LA  - eng
PT  - Clinical Trial, Phase IV
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Cardiovasc Pharmacol
JT  - Journal of cardiovascular pharmacology
JID - 7902492
RN  - 0 (Hydroxymethylglutaryl-CoA Reductase Inhibitors)
RN  - 0 (Quinolines)
RN  - M5681Q5F9P (pitavastatin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Area Under Curve
MH  - Case-Control Studies
MH  - Female
MH  - Glomerular Filtration Rate
MH  - Humans
MH  - Hydroxymethylglutaryl-CoA Reductase Inhibitors/*adverse effects/pharmacokinetics
MH  - Male
MH  - Middle Aged
MH  - Quinolines/*adverse effects/pharmacokinetics
MH  - Renal Insufficiency/*physiopathology
MH  - Severity of Illness Index
EDAT- 2012/04/05 06:00
MHDA- 2012/12/29 06:00
CRDT- 2012/04/05 06:00
PHST- 2012/04/05 06:00 [entrez]
PHST- 2012/04/05 06:00 [pubmed]
PHST- 2012/12/29 06:00 [medline]
AID - 10.1097/FJC.0b013e318256cdf0 [doi]
PST - ppublish
SO  - J Cardiovasc Pharmacol. 2012 Jul;60(1):42-8. doi: 10.1097/FJC.0b013e318256cdf0.