No effects of pantoprazole on the pharmacokinetics of rosuvastatin in healthy subjects

Eur J Clin Pharmacol. 2016 Aug;72(8):925-31. doi: 10.1007/s00228-016-2065-6. Epub 2016 May 5.

Abstract

Purpose: Rosuvastatin disposition is modulated by the expression and activity of several membrane transporters including BCRP (ABCG2). The objective of our study was to investigate the effects of pantoprazole, a previously proposed BCRP inhibitor, on the disposition of rosuvastatin.

Methods: The impact of pantoprazole (40 mg ID for 2 days) on rosuvastatin pharmacokinetics was evaluated in healthy volunteers (n = 16) who received a single oral dose of rosuvastatin (10 mg) either alone or with pantoprazole. Rosuvastatin, N-desmethylrosuvastatin, and rosuvastatin lactone levels were quantified in plasma while rosuvastatin and N-desmethylrosuvastatin excretion were measured in urine.

Results: Ratios and 90 % standard confidence interval of geometric means for C max (1.03 [0.91-1.16]), AUC0-∞ (1.03 [0.89-1.19]) and renal clearance (0.96 [0.85-1.09]) were all within the pre-specified range of 0.8-1.25, indicating a lack of drug-drug interaction between pantoprazole and rosuvastatin.

Conclusions: Concomitant administration of pantoprazole with rosuvastatin did not affect rosuvastatin plasma concentrations. The use of pantoprazole as a BCRP inhibitor should be revisited when characterizing BCRP-mediated transport in humans.

Keywords: ABCG2; BCRP; Drug interaction; Pantoprazole; Pharmacokinetics; Rosuvastatin; Transporters.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles / pharmacology*
  • ATP Binding Cassette Transporter, Subfamily G, Member 2 / antagonists & inhibitors
  • ATP Binding Cassette Transporter, Subfamily G, Member 2 / genetics
  • Adolescent
  • Adult
  • Cross-Over Studies
  • Cytochrome P-450 CYP2C19 / genetics
  • Drug Interactions
  • Genotype
  • Healthy Volunteers
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / blood
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / pharmacokinetics*
  • Lactones / blood
  • Liver-Specific Organic Anion Transporter 1 / genetics
  • Male
  • Middle Aged
  • Neoplasm Proteins / antagonists & inhibitors
  • Neoplasm Proteins / genetics
  • Pantoprazole
  • Polymorphism, Single Nucleotide
  • Proton Pump Inhibitors / pharmacology*
  • Pyrimidines / blood
  • Rosuvastatin Calcium / blood
  • Rosuvastatin Calcium / pharmacokinetics*
  • Sulfonamides / blood
  • Young Adult

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • ABCG2 protein, human
  • ATP Binding Cassette Transporter, Subfamily G, Member 2
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Lactones
  • Liver-Specific Organic Anion Transporter 1
  • N-desmethylrosuvastatin
  • Neoplasm Proteins
  • Proton Pump Inhibitors
  • Pyrimidines
  • SLCO1B1 protein, human
  • Sulfonamides
  • Rosuvastatin Calcium
  • Pantoprazole
  • CYP2C19 protein, human
  • Cytochrome P-450 CYP2C19
  • rosuvastatin lactone