Topic Highlight
Copyright ©2014 Baishideng Publishing Group Inc. All rights reserved.
World J Cardiol. May 26, 2014; 6(5): 234-244
Published online May 26, 2014. doi: 10.4330/wjc.v6.i5.234
Anti-hypertensive drugs in children and adolescents
Patricia Y Chu, Michael J Campbell, Stephen G Miller, Kevin D Hill
Patricia Y Chu, Kevin D Hill, Duke Clinical Research Institute, Durham, NC 27715, United States
Michael J Campbell, Stephen G Miller, Kevin D Hill, Division of Pediatric Cardiology, Department of Pediatrics, Duke University Medical Center, Durham, NC 27715, United States
Author contributions: Chu PY, Campbell MJ, Miller SG and Hill KD contributed to the manuscript literature review, data compilation and writing.
Correspondence to: Kevin D Hill, MD, MSCI, Assistant Professor of Pediatrics in the Division of Pediatric Cardiology, Division of Pediatrics, Duke University Medical Center, Duke Clinical Research Institute, 2400 Pratt Street, Room 7582, Box 3850 Durham, NC 27705, United States. kevin.hill@duke.edu
Telephone: +1-919-6684686 Fax: +1-919-6687058
Received: December 27, 2013
Revised: January 27, 2014
Accepted: April 16, 2014
Published online: May 26, 2014
Processing time: 175 Days and 17.8 Hours
Abstract

Worldwide the prevalence of essential hypertension in children and adolescents continues to increase. Traditionally providers have used “off-label” drugs to treat pediatric hypertension, meaning that rigorous clinical trials of these drugs have not been specifically performed in pediatric patient populations. Consequently providers have extrapolated dosing, safety and efficacy from trials in adults. This practice is sub-optimal as children demonstrate unique differences in drug metabolism and response. Use of unstudied or understudied drugs increases risk of adverse events and/or can lead to sub-optimal efficacy. Recognizing these concerns, regulatory agencies have created financial incentives for industry to conduct pediatric clinical trials. These incentives, coupled with the emerging pediatric hypertension epidemic, have spurred over 30 clinical trials of anti-hypertensive drugs over the past 15 years and have resulted in labeling of 10 new drugs by the United States Food and Drug Administration for treatment of hypertension in children and adolescents. Unfortunately the financial incentive structures focus on newer drugs and drug classes. Consequently there is now a relative dearth of trial data for older but sometimes commonly prescribed pediatric antihypertensive drugs. This article reviews recent pediatric antihypertensive drug trials with a focus on trial design and endpoints, drug dosing, safety, efficacy and specific drug indications. We also review the available data and experience for some of the more commonly prescribed, but less well studied “older” pediatric antihypertensive drugs.

Keywords: Hypertension; Children; Clinical trials; Dosing; Safety

Core tip: This review focuses on the major clinical trials of anti-hypertensive drugs that have been completed over the past 15 years in response to regulatory initiatives by the United States Food and Drug Administration and the European Medicines Agency. These trials have changed the landscape of anti-hypertensive drug management in children.