Effect of dronedarone on renal function in healthy subjects

Br J Clin Pharmacol. 2007 Dec;64(6):785-91. doi: 10.1111/j.1365-2125.2007.02998.x. Epub 2007 Jul 27.


Aims: To assess the effects of dronedarone on renal function and tubular cation handling.

Methods: Twelve healthy males were enrolled in a randomized, cross-over, placebo-controlled, double-blind study. They received 400 mg dronedarone or placebo twice daily for 7 days. Baseline and on-treatment renal function tests were performed under strict standardization of intakes, by assessing creatinine, sinistrin, para-amino-hippurate (PAH) and N-methylnicotinamide (NMN) CLs, and electrolyte excretion.

Results: Compared with placebo, dronedarone significantly decreased renal creatinine CL (mean 138-119 ml min(-1) after dronedarone vs. 142-149 ml min(-1) after placebo) and NMN CL (448-368 ml min(-1)vs. 435-430 ml min(-1)), but did not alter renal sinistrin CL, PAH CL and other renal parameters.

Conclusions: Dronedarone reduces renal creatinine and NMN clearance by about 18%, without evidence of an effect on GFR, renal plasma flow or electrolyte exchanges. This suggests a specific partial inhibition of tubular organic cation transporters (OCT). A limited increase in serum creatinine is therefore expected with dronedarone treatment, but does not mean there is a decline in renal function.

Publication types

  • Clinical Trial, Phase I
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Amiodarone / analogs & derivatives*
  • Amiodarone / pharmacology
  • Cross-Over Studies
  • Double-Blind Method
  • Dronedarone
  • Glomerular Filtration Rate / drug effects
  • Glomerular Filtration Rate / physiology
  • Humans
  • Kidney / drug effects*
  • Kidney / metabolism*
  • Kidney Function Tests / methods
  • Male
  • Metabolic Clearance Rate / drug effects
  • Metabolic Clearance Rate / physiology


  • Dronedarone
  • Amiodarone