Longitudinal monitoring of CYP3A activity in patients receiving 3 cycles of itraconazole pulse therapy for onychomycosis

J Clin Pharm Ther. 2014 Apr;39(2):181-5. doi: 10.1111/jcpt.12127. Epub 2014 Jan 10.

Abstract

What is known and objective: Itraconazole, a CYP3A inhibitor, is used for the treatment for onychomycosis with a three-cycle pulse therapy over 3 months, but its effects on in vivo CYP3A activity during the entire course remain unknown.

Methods: Urinary 6β-hydroxycortisol/cortisol ratios were determined in 19 patients with onychomycosis, before therapy, during three cycles of itraconazole pulse therapy (200 mg twice daily for a week in each monthly cycle) and at 3 month after completion of therapy.

Results and discussion: The mean 6β-hydroxycortisol/cortisol ratio was reduced by 68% from baseline (P < 0·05) after the 1st pulse dosing, but the inhibitory effect appeared to be resolved before the next pulse dosing and at 3 months post-treatment. The magnitude of inhibition appeared in proportion to the baseline CYP3A activity.

What is new and conclusion: The inhibitory effect of itraconazole pulse therapy on the in vivo CYP3A activity appears clinically relevant at the end of each cycle, but the inhibition resolves, on average, within 3 weeks.

Keywords: CYP3A; itraconazole; metabolic inhibition; onychomycosis; pulse therapy.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antifungal Agents / administration & dosage
  • Antifungal Agents / pharmacology
  • Antifungal Agents / therapeutic use*
  • Cytochrome P-450 CYP3A Inhibitors*
  • Drug Monitoring / methods
  • Enzyme Inhibitors / administration & dosage
  • Enzyme Inhibitors / pharmacology
  • Enzyme Inhibitors / therapeutic use
  • Female
  • Follow-Up Studies
  • Humans
  • Hydrocortisone / analogs & derivatives
  • Hydrocortisone / urine
  • Itraconazole / administration & dosage
  • Itraconazole / pharmacology
  • Itraconazole / therapeutic use*
  • Longitudinal Studies
  • Male
  • Middle Aged
  • Onychomycosis / drug therapy*
  • Pulse Therapy, Drug
  • Time Factors
  • Treatment Outcome

Substances

  • Antifungal Agents
  • Cytochrome P-450 CYP3A Inhibitors
  • Enzyme Inhibitors
  • Itraconazole
  • 6 beta-hydroxycortisol
  • Hydrocortisone