• Br J Clin Pharmacol · Dec 2007

    Randomized Controlled Trial Comparative Study

    Effect of dronedarone on renal function in healthy subjects.

    • Yvonne Tschuppert, Thierry Buclin, Laura E Rothuizen, Laurent A Decosterd, Jacques Galleyrand, Christine Gaud, and Jérôme Biollaz.
    • Clinical Pharmacology and Toxicology, University Hospital, Lausanne, Switzerland.
    • Br J Clin Pharmacol. 2007 Dec 1; 64 (6): 785-91.

    AimsTo assess the effects of dronedarone on renal function and tubular cation handling.MethodsTwelve 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.ResultsCompared 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.ConclusionsDronedarone 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.

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