Key result
Modeling and simulation accurately predicted blood pressure reduction, supporting olmesartan dosing of 10 mg (<35 kg) and 20 mg (≥35 kg) in pediatric patients aged 6 to 16 years with hypertension.
Why the study?
Does modeling and simulation accurately predict the dose-response relationship of olmesartan medoxomil in pediatric patients with hypertension?
Does modeling and simulation accurately predict the dose-response relationship of olmesartan medoxomil in pediatric patients with hypertension?
Pharmacokinetic modeling and simulation successfully guided the clinical development and weight-based dosing recommendations for olmesartan in pediatric hypertension.
Supports weight-based olmesartan dosing in pediatric hypertension; confirms modeling and simulation for pediatric dose selection.
Modeling and simulation were used extensively in the development of an indication for the use of olmesartan medoxomil in pediatric patients with hypertension. Simulations based on models developed in adult patients indicated that two dose groups were sufficient to estimate a dose-response relationship, thereby reducing by one-third the number of subjects required for the phase III pediatric study. Model-based predictions for blood pressure reduction agreed with the observed results of the subsequent phase III study, showing statistically significant dose-response relationships with respect to both systolic and diastolic blood pressure. Previously established pharmacokinetic and exposure-response relationships in adults, adjusted for the influence of body weight on clearance (wt(0.80)), were confirmed in the pediatric population. Together, these findings support an olmesartan dosing recommendation in pediatric subjects aged 6 to 16 years of 10 mg for subjects weighing <35 kg and 20 mg for those weighing ≥35 kg.
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Salazar et al. (2011) studied Hypertension. Olmesartan medoxomil was evaluated on Blood pressure reduction (systolic and diastolic). Modeling and simulation accurately predicted blood pressure reduction, supporting olmesartan dosing of 10 mg (<35 kg) and 20 mg (≥35 kg) in pediatric patients aged 6 to 16 years with hypertension.
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