Influence of Renal Impairment on Pharmacokinetics Obtained from Serum Glycoside Concentration after Administration of Beta-methyldigoxin

Abstract

The pharmacokinetics of beta-methyldigoxin (β-MD) was investigated after a single oral administration (0.2mg) in 24 subjects with varying degrees of renal function. The subjects were assigned to four groups on the basis of predetermined 1-hour creatinine clearance (CL_CR; ml/min/1.48m²) [group I (hemodialysis), CL_CR<10; group II, 10≤CL_CR<50; group III, 50≤CL_CR<75; group IV, 75≤CL_CR]. Serum glycoside concentrations were measured by fluorescence polarization immunoassay. The mean peak concentration and the time to reach peak concentration were not different among the groups. The dependency of β-MD kinetics on renal function was demonstrated in the present study. Significant relationships were observed between CL_CR and pharmacokinetic parameters [total body clearance (r=0.446, P<0.05), AUC (r=-0.639, P<0.001), volume of distribution at steady state (r=0.738, P<0.001)]. The dosage of β-MD should be reduced by the same manner as digoxin dosage regimen in renal impairment.