Key result
Irbesartan geometric mean AUC and Cmax increased by 43% and 49%, respectively, in elderly subjects compared to young subjects, with no significant gender effects observed.
Why the study?
Does age or gender affect the pharmacokinetics and safety of a single dose of irbesartan in healthy subjects?
Population
48 healthy subjects (12 young men, 12 young women, 12 elderly men, and 12 elderly women)
Comparison
Irbesartan 50 mg single oral dose administered… vs Comparison between age groups and gender
Design
Other
Follow-up
96 hours after the dose
Authors
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No dosage adjustment indicated for age or gender; extends single-dose PK data but leaves open effects in patients with comorbidities.
Does age or gender affect the pharmacokinetics and safety of a single dose of irbesartan in healthy subjects?
p-value: p=≤0.001
Age, but not gender, significantly affects the pharmacokinetics of irbesartan, though these changes do not necessitate dosage adjustments.
Vachharajani et al. (1998) studied Healthy subjects (n=48). Irbesartan vs. Young subjects was evaluated on Area under the curve (AUC) for age effect (95% CI 1.192-1.709, p=≤0.001). Irbesartan geometric mean AUC and Cmax increased by 43% and 49%, respectively, in elderly subjects compared to young subjects, with no significant gender effects observed.
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