Effect of dronedarone on renal function in healthy subjects

Publisher Website
Google Scholar
Abstract
To assess the effects of dronedarone on renal function and tubular cation handling. 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. 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. 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.