Antihypertensive therapy: basic pharmacokinetic and pharmacodynamic principles as applied to infants and children

Increased attention has been paid to the study of antihypertensive agents in children following the Food and Drug Administration Modernization Act. Many short-term studies of drug effectiveness and safety are underway or recently completed. Defining the disposition of antihypertensive agents in the pediatric population has become an important part of ongoing efforts to label antihypertensive agents for use in children. In comparison with larger trials done in the adult population, relatively few pediatric subjects will be studied. Hence, it is important to gather as much information as possible for each agent during pediatric trials. Appropriate study design is dependent not only on a working knowledge of the unique features of hypertension in children, but also on a practical assessment of factors that affect drug disposition in children. Basic principles of pharmacokinetics (PK), pharmacodynamics (PD), and PK-PD modeling as applied to pediatric antihypertensive therapy are briefly considered.