Efficacy and Safety Measurements of Proton Pump Inhibitors in Infants and Children

Abstract

ABSTRACTThe design of studies to evaluate the efficacy of acid‐lowering drugs in children differs significantly from study designs in adult populations. Efficacy measurements may be less extensive than those used in adult studies because of limitations that exist secondary to concerns for patient safety, parental and institutional review board acceptance of efficacy end points, and existing standards of care within the pediatric gastroenterology community. Study designs involving patients who would routinely receive acid‐lowering therapy have been successfully used to characterize the pharmacokinetics and pharmacodynamics of acid‐lowering therapies (H2 receptor antagonists) and have led to pediatric labeling for these drugs. This approach may likewise be used in the study of newer acid‐lowering agents, such as proton pump inhibitors.