Key result
Irbesartan pharmacokinetics showed no statistically significant relationship with creatinine clearance, indicating no starting dose adjustment is necessary in renal impairment or hemodialysis.
Why the study?
Does renal impairment or hemodialysis alter the pharmacokinetics of irbesartan in subjects with varying degrees of renal function?
Population
40 subjects with varying degrees of renal function
Comparison
Irbesartan 100 mg daily for 8 days vs Subjects with normal renal function
Design
Cohort, open-label
Follow-up
8 to 9 days
Authors
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Supports no irbesartan dose adjustment by renal function; leaves open long-term outcome data in severe CKD and hemodialysis.
Does renal impairment or hemodialysis alter the pharmacokinetics of irbesartan in subjects with varying degrees of renal function?
Irbesartan does not require starting dose adjustment in patients with mild to severe renal impairment or those on hemodialysis.
Sica et al. (1997) studied Renal failure (n=40). Irbesartan vs. Normal renal function was evaluated on Pharmacokinetics (maximum plasma concentrations, dose-adjusted area under the plasma concentration time curve). Irbesartan pharmacokinetics showed no statistically significant relationship with creatinine clearance, indicating no starting dose adjustment is necessary in renal impairment or hemodialysis.
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