No Effect of Rosuvastatin on the Pharmacokinetics of Digoxin in Healthy Volunteers

The effect of rosuvastatin on the pharmacokinetics of digoxin was assessed in 18 healthy male volunteers in this double‐blind, randomized, two‐way crossover trial. Volunteers were dosed with rosuvastatin (40 mg once daily) or placebo to steady state before being given a single dose of digoxin 0.5 mg...

Full description

Saved in:
Bibliographic Details
Published in:Journal of clinical pharmacology 2002-12, Vol.42 (12), p.1352-1357
Main Authors: Martin, Paul D., Kemp, John, Dane, Aaron L., Warwick, Mike J., Schneck, Dennis W.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Area Under Curve
Biological and medical sciences
Cardiotonic agents
Cardiovascular system
Cross-Over Studies
Digoxin - pharmacokinetics
Double-Blind Method
Drug Administration Schedule
Drug Interactions
Fluorobenzenes - blood
Fluorobenzenes - pharmacology
Fluorobenzenes - urine
General and cellular metabolism. Vitamins
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - blood
Hydroxymethylglutaryl-CoA Reductase Inhibitors - pharmacology
Hydroxymethylglutaryl-CoA Reductase Inhibitors - urine
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Pyrimidines
Rosuvastatin Calcium
Sulfonamides
Time Factors
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:The effect of rosuvastatin on the pharmacokinetics of digoxin was assessed in 18 healthy male volunteers in this double‐blind, randomized, two‐way crossover trial. Volunteers were dosed with rosuvastatin (40 mg once daily) or placebo to steady state before being given a single dose of digoxin 0.5 mg. Blood and urine samples for the measurement of serum and urine digoxin concentrations were collected up to 96 hours following dosing. The effect of rosuvastatin was assessed by constructing 90% confidence intervals (CIs) around the treatment ratios (rosuvastatin + digoxin/placebo + digoxin) for digoxin exposure. The geometric least square mean AUC0‐t and Cmax of digoxin were only 4% higher when the drug was coadministered with rosuvastatin compared to placebo. The 90% CIs for both treatment ratios (AUC0‐t = 0.88‐1.24; Cmax = 0.89‐1.22) fell within the prespecified margin of 0.74 to 1.35; therefore, no significant pharmacokinetic interaction occurred between rosuvastatin and digoxin. The geometric mean amount of digoxin excreted into the urine and its renal clearance were similar with rosuvastatin and placebo. These results demonstrate that rosuvastatin has no effect on the pharmacokinetics of digoxin. Coadministration of rosuvastatin and digoxin was well tolerated.
ISSN:0091-2700
1552-4604
DOI:10.1177/0091270002042012008