Potential for pharmacokinetic interactions between ambrisentan and cyclosporine

Clin Pharmacol Ther. 2010 Oct;88(4):513-20. doi: 10.1038/clpt.2010.120. Epub 2010 Sep 1.

Abstract

Ambrisentan (ABS), approved for the treatment of pulmonary arterial hypertension and administered as an oral dose once daily, is an ET(A)-selective endothelin receptor antagonist (ERA) and a potential substrate for cytochrome P450 (CYP) 3A4, organic anion-transporting polypeptide (OATP), and P-glycoprotein (P-gp). Cyclosporin A (CsA), an inhibitor of CYP3A4, P-gp, and OATP, may be used concomitantly with ABS. In this open-label, parallel-treatment study, 28 healthy subjects received steady-state ABS (5 mg q.d.) either alone or with steady-state CsA (100-150 mg b.i.d.), and 24 other subjects received steady-state CsA either alone or with steady-state ABS. In the presence of CsA, ABS maximum plasma concentration (C(max)) increased 1.5-fold, and area under the plasma concentration-time curve (AUC)(0-τ) increased twofold. Marginal increases were observed for CsA C(max) (906 vs. 1,014 ng/ml) and AUC(0-τ) (3.05 vs. 3.37 µg·h/ml) in the presence of ABS. Frequent adverse events (AEs) were headache and gastrointestinal disorders. The addition of ABS to steady-state CsA appeared less tolerable as compared with the addition of CsA to steady-state ABS. A maximum ABS dose of 5 mg is recommended if it is coadministered with CsA. No change in CsA dose is recommended if it is coadministered with ABS.

Publication types

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

MeSH terms

  • ATP Binding Cassette Transporter, Subfamily B, Member 1 / antagonists & inhibitors
  • Adult
  • Antihypertensive Agents / adverse effects
  • Antihypertensive Agents / pharmacokinetics
  • Antihypertensive Agents / pharmacology*
  • Area Under Curve
  • Cyclosporine / adverse effects
  • Cyclosporine / pharmacokinetics
  • Cyclosporine / pharmacology*
  • Cytochrome P-450 CYP3A
  • Cytochrome P-450 CYP3A Inhibitors
  • Drug Interactions
  • Endothelin Receptor Antagonists*
  • Female
  • Humans
  • Immunosuppressive Agents / adverse effects
  • Immunosuppressive Agents / pharmacokinetics
  • Immunosuppressive Agents / pharmacology*
  • Male
  • Organic Anion Transporters / antagonists & inhibitors
  • Phenylpropionates / adverse effects
  • Phenylpropionates / pharmacokinetics
  • Phenylpropionates / pharmacology*
  • Pyridazines / adverse effects
  • Pyridazines / pharmacokinetics
  • Pyridazines / pharmacology*

Substances

  • ATP Binding Cassette Transporter, Subfamily B, Member 1
  • Antihypertensive Agents
  • Cytochrome P-450 CYP3A Inhibitors
  • Endothelin Receptor Antagonists
  • Immunosuppressive Agents
  • Organic Anion Transporters
  • Phenylpropionates
  • Pyridazines
  • Cyclosporine
  • Cytochrome P-450 CYP3A
  • CYP3A4 protein, human
  • ambrisentan