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Safety of placebo controls in pediatric hypertension trials
P Brian Smith1, Jennifer S Li, M Dianne Murphy
1Food and Drug Administration, Rockville, Md., USA. brian.smith@duke.edu
Insights
In pediatric hypertension trials, using a placebo arm is safe. This study found no increased risk of adverse events for children receiving placebo compared to active antihypertensive drugs.
Area of Science:
- Pediatric Cardiology
- Clinical Pharmacology
- Medical Ethics
Background:
- Clinical trials often include placebo arms, even for conditions with existing treatments.
- The safety of placebo use in pediatric hypertension trials is not well-established.
- Antihypertensive medication trials in children frequently utilize placebo controls.
Purpose of the Study:
- To assess the safety of placebo use in pediatric antihypertensive trials.
- To determine adverse event rates in children receiving placebo versus active drugs.
- To evaluate the risk associated with short-term placebo exposure in pediatric hypertension studies.
Main Methods:
- Pooled patient-level data from 10 short-term antihypertensive efficacy trials in pediatric patients (1998-2005).
- Analysis of adverse events reported during the placebo-controlled phases of these trials.
- Comparison of adverse event rates between placebo and active drug groups.
Main Results:
- No significant difference in adverse event rates was observed between placebo and active drug groups.
- Out of 1707 children, only 5 experienced serious adverse events, with none attributed to study drugs.
- One serious adverse event occurred in the placebo group, with no investigator-assigned relation to the study drug.
Conclusions:
- Short-term use of placebo in pediatric antihypertensive medication trials appears safe.
- The findings support the continued use of placebo controls in pediatric hypertension research under specific conditions.
- Pediatric patients in these trials did not face increased risks from placebo exposure.
Abstract:
Many clinical trials, including those in pediatric populations, use a placebo arm for medical conditions for which there are readily available therapeutic interventions. Several short-term efficacy trials of antihypertensive medications performed in response to Food and Drug Administration-issued written requests have used a placebo arm; whether the use of a placebo arm is safe in children with hypertension is unknown. We sought to define the rates of adverse events in 10 short-term antihypertensive trials to determine whether these trials resulted in increased risk to pediatric patients receiving placebo. We combined patient-level data from 10 antihypertensive efficacy trials performed in pediatric patients that were submitted to the Food and Drug Administration from 1998 to 2005. We determined the number and type of all of the adverse events reported during the placebo-controlled portion of the clinical trials and compared these numbers between the patients who received placebo and those who received active drug. Among the 1707 children in the 10 studies, we observed no differences in the rates of adverse events reported between the patients who received placebo and those who received active drug. Only 5 patients suffered a serious adverse event during the trials; none were thought by the investigators to be related to study drug, and only 1 occurred in a patient receiving placebo. Short-term exposure to placebo in pediatric trials of antihypertensive medications appears to be safe.
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