Worldwide the prevalence of essential hypertension inchildren and adolescents continues to increase. Tradi-tionally providers have used "off-label" drugs to treatpediatric hypertension, meaning that rigorous...Worldwide the prevalence of essential hypertension inchildren and adolescents continues to increase. Tradi-tionally providers have used "off-label" drugs to treatpediatric hypertension, meaning that rigorous clinicaltrials of these drugs have not been specifically per-formed in pediatric patient populations. Consequentlyproviders have extrapolated dosing, safety and efficacyfrom trials in adults. This practice is sub-optimal as chil-dren demonstrate unique differences in drug metabo-lism and response. Use of unstudied or understudieddrugs increases risk of adverse events and/or can leadto sub-optimal efficacy. Recognizing these concerns,regulatory agencies have created financial incentivesfor industry to conduct pediatric clinical trials. Theseincentives, coupled with the emerging pediatric hyper-tension epidemic, have spurred over 30 clinical trialsof anti-hypertensive drugs over the past 15 years andhave resulted in labeling of 10 new drugs by the UnitedStates Food and Drug Administration for treatment ofhypertension in children and adolescents. Unfortunatelythe financial incentive structures focus on newer drugsand drug classes. Consequently there is now a relativedearth of trial data for older but sometimes commonlyprescribed 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.展开更多
文摘Worldwide the prevalence of essential hypertension inchildren and adolescents continues to increase. Tradi-tionally providers have used "off-label" drugs to treatpediatric hypertension, meaning that rigorous clinicaltrials of these drugs have not been specifically per-formed in pediatric patient populations. Consequentlyproviders have extrapolated dosing, safety and efficacyfrom trials in adults. This practice is sub-optimal as chil-dren demonstrate unique differences in drug metabo-lism and response. Use of unstudied or understudieddrugs increases risk of adverse events and/or can leadto sub-optimal efficacy. Recognizing these concerns,regulatory agencies have created financial incentivesfor industry to conduct pediatric clinical trials. Theseincentives, coupled with the emerging pediatric hyper-tension epidemic, have spurred over 30 clinical trialsof anti-hypertensive drugs over the past 15 years andhave resulted in labeling of 10 new drugs by the UnitedStates Food and Drug Administration for treatment ofhypertension in children and adolescents. Unfortunatelythe financial incentive structures focus on newer drugsand drug classes. Consequently there is now a relativedearth of trial data for older but sometimes commonlyprescribed 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.
