Safety of placebo controls in pediatric hypertension trials.

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Smith, PB; Li, JS; Murphy, MD; Califf, RM; Benjamin, DK

Published Date

  • April 2008

Published In

Volume / Issue

  • 51 / 4

Start / End Page

  • 829 - 833

PubMed ID

  • 18285612

Pubmed Central ID

  • 18285612

Electronic International Standard Serial Number (EISSN)

  • 1524-4563

International Standard Serial Number (ISSN)

  • 0194-911X

Digital Object Identifier (DOI)

  • 10.1161/HYPERTENSIONAHA.107.104950

Language

  • eng