What question did this study set out to answer?

February 1, 1996The Journal of Clinical Pharmacology

Disposition of Intravenous Amiodarone in Subjects with Normal and Impaired Renal Function

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Why the study?

Does renal impairment alter the pharmacokinetic disposition of intravenous amiodarone?

Population

30 subjects, including 11 with normal renal function, 9 with renal impairment, and 10 long-term hemodialysis…

Comparison

Single 5 mg/kg intravenous dose of amiodarone… vs Comparison across three groups: normal renal…

Design

Cohort

Authors

MUMichael R. UjhelyiUniversity of Florida KKKaren J. KlamerusPfizer (United States)KVKiumars VadieiUniversity of Houston

Discussion

Member takes

Implication

May not require IV amiodarone dosage adjustment in renal impairment; hypothesis-generating and should not yet change practice.

Key Points

Determine whether renal dysfunction alters the pharmacokinetic disposition of intravenous amiodarone and its active metabolite, desethylamiodarone.
Administered a single 5 mg/kg intravenous dose of amiodarone over 15 minutes to 30 subjects grouped by kidney function: normal renal function (N=11), renal impairment (N=9), and long-term hemodialysis (N=10).
Measured total and free concentrations of amiodarone and desethylamiodarone using high-performance liquid chromatography.
Mean systemic clearance, steady-state volume of distribution, and mean residence time of amiodarone showed no significant differences among the three groups.
Amiodarone area under the concentration-time curve was significantly higher in subjects with normal renal function than in those with renal impairment, an effect related to total body weight.
Unbound drug fractions were similar between normal and hemodialysis cohorts, demonstrating no requirement for renal dose adjustments.

Structured PICO

Does renal impairment alter the pharmacokinetic disposition of intravenous amiodarone?

Population

30 subjects, including 11 with normal renal function (mean GFR 118 +/- 20 mL/min/1.73 m2), 9 with renal impairment (mean GFR 23 +/- 10 mL/min/1.73 m2), and 10 long-term hemodialysis patients.

Intervention

Single 5 mg/kg intravenous dose of amiodarone over 15 minutes.

Comparator

Comparison across three groups: normal renal function, impaired renal function, and end-stage renal disease on hemodialysis.

Outcome

Pharmacokinetic disposition of amiodarone and its metabolite desethylamiodarone (DEA), including systemic clearance, steady state volume of distribution, and mean residence time.surrogate

The disposition of intravenous amiodarone is not significantly altered by renal dysfunction, indicating that dosage adjustment is not necessary in patients with renal impairment or end-stage renal disease.

Cite This Study

Ujhelyi et al. (1996) studied this question.

synapsesocial.com/papers/6a7101de5d37378ac1de2c88 https://doi.org/10.1002/j.1552-4604.1996.tb04177.x

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Disposition of Intravenous Amiodarone in Subjects with Normal and Impaired Renal Function

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

Disposition of Intravenous Amiodarone in Subjects with Normal and Impaired Renal Function

Discussion

Member takes

Implication

Key Points

Structured PICO

Cite This Study

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