Role of p-glycoprotein inhibition for drug interactions: evidence from in vitro and pharmacoepidemiological studies

Clin Pharmacokinet. 2007;46(12):1039-49. doi: 10.2165/00003088-200746120-00004.

Abstract

Objectives: We determined in vitro the potency of macrolides as P-glycoprotein inhibitors and tested in hospitalised patients whether coadministration of P-glycoprotein inhibitors leads to increased serum concentrations of the P-glycoprotein substrates digoxin and digitoxin.

Methods: In vitro, the effect of macrolides on polarised P-glycoprotein-mediated digoxin transport was investigated in Caco-2 cells. In a pharmacoepidemiological study, we analysed the serum digoxin and digitoxin concentrations with and without coadministration of P-glycoprotein inhibitors in hospitalised patients.

Results: All macrolides inhibited P-glycoprotein-mediated digoxin transport, with concentrations producing 50% inhibition (IC(50)) values of 1.8, 4.1, 15.4, 21.8 and 22.7 micromol/L for telithromycin, clarithromycin, roxithromycin, azithromycin and erythromycin, respectively. Coadministration of P-glycoprotein inhibitors was associated with increased serum concentrations of digoxin (1.3 +/- 0.6 vs 0.9 +/- 0.5 ng/mL, p < 0.01). Moreover, patients receiving macrolides had higher serum concentrations of cardiac glycosides (p < 0.05).

Conclusion: Macrolides are potent inhibitors of P-glycoprotein. Drug interactions between P-glycoprotein inhibitors and substrates are likely to occur during hospitalisation.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • ATP Binding Cassette Transporter, Subfamily B, Member 1 / antagonists & inhibitors*
  • ATP Binding Cassette Transporter, Subfamily B, Member 1 / physiology
  • Aged
  • Aged, 80 and over
  • Alanine Transaminase / blood
  • Aspartate Aminotransferases / blood
  • Bilirubin / blood
  • Biological Transport
  • Caco-2 Cells
  • Creatinine / blood
  • Digitoxin / administration & dosage
  • Digitoxin / blood
  • Digitoxin / pharmacokinetics
  • Digoxin / administration & dosage
  • Digoxin / blood
  • Digoxin / pharmacokinetics
  • Drug Interactions
  • Erythromycin / administration & dosage
  • Erythromycin / pharmacokinetics
  • Female
  • Heart Diseases / blood
  • Heart Diseases / metabolism*
  • Heart Diseases / physiopathology
  • Humans
  • Inpatients
  • Inulin / administration & dosage
  • Inulin / blood
  • Inulin / pharmacokinetics
  • Ketolides / administration & dosage
  • Ketolides / pharmacokinetics
  • Macrolides / administration & dosage
  • Macrolides / pharmacokinetics*
  • Male
  • Pharmacoepidemiology / methods

Substances

  • ATP Binding Cassette Transporter, Subfamily B, Member 1
  • Ketolides
  • Macrolides
  • Erythromycin
  • Digoxin
  • Inulin
  • Creatinine
  • Digitoxin
  • Aspartate Aminotransferases
  • Alanine Transaminase
  • telithromycin
  • Bilirubin