Pediatric use of antihypertensive medications: much more to learn

Flynn, Joseph T.

doi:10.1016/s0011-393x(01)80015-1

Cited by 31 publications

(14 citation statements)

References 64 publications

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“…For many years information regarding use of antihypertensive medications in children has been limited because of the reluctance of industry to conduct clinical trials in this population [14,15,16]. As a result physicians caring for children with hypertension have had to rely on the results of studies conducted in adults for information regarding the efficacy, dosing, and adverse effects of these agents.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of prolonged amlodipine treatment in hypertensive children

Flynn

2005

Pediatr Nephrol

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To examine the long-term efficacy and safety of amlodipine in hypertensive children, data on prolonged use (> or = 6 months) of amlodipine in 33 children were reviewed. All children received amlodipine as sole therapy for their hypertension. Causes of hypertension included solid organ transplant (n=19), renal disease (n=7) primary hypertension (n=6), and drug-induced hypertension (n=1). Mean patient age at the start of amlodipine treatment was 9.8+/-4.8 years (range 1.3-16.9); there were 19 boys and 14 girls. Mean duration of amlodipine treatment was 20.4+/-11.5 months (range 6-48). Analysis of blood pressure and dosing data revealed that blood pressure reduction was sustained throughout the period of amlodipine treatment, while amlodipine dose remained stable (mean effective daily dose 0.17+/-0.12 mg/kg). No patient required discontinuation of amlodipine because of adverse effects. This small study suggests that prolonged amlodipine treatment is well tolerated in hypertensive children and provides sustained blood pressure control. Further studies are necessary to determine what effects if any long-term calcium channel blocker treatment has on the growth and development of children with hypertension.

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of prolonged amlodipine treatment in hypertensive children

Flynn

2005

Pediatr Nephrol

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“…164, 165 The addition of amlodipine, a long-acting calcium channel blocker, to the existing regimen may decrease the incidence of cardiovascular events in patients with angina or myocardial ischemia secondary to myocardial infarction. However, amlodipine should not be administered to patients with congestive heart failure and those with atrioventricular block.…”

Section: Calcium Channel Blockersmentioning

confidence: 99%

Guidelines for Diagnosis and Management of Cardiovascular Sequelae in Kawasaki Disease (JCS 2013)

2014

Circ J

210

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“…In the case of antihypertensives, as recently as 2000, the Physicians Drug Reference (PDR) contained pediatric indications and/or manufacturer's dosing recommendations in the prescribing information for fewer than one third of the most commonly prescribed agents. 13 As a result, pediatricians are left with the option of prescribing medications for their patients that have been studied only in adults, an example of so-called "off-label" prescribing. Although such off-label use is common in pediatrics, in effect it means that each prescription written is literally an experiment with potential untoward consequences.…”

Section: Ethics Of Clinical Research In Childrenmentioning

confidence: 99%

Ethics of Placebo Use in Pediatric Clinical Trials

Flynn

2003

Hypertension

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Abstract-Industry-sponsored pediatric clinical trials of antihypertensive medications have greatly increased in number since passage of the Food and Drug Modernization Act of 1997. This development should ultimately benefit the treatment of hypertensive children by increasing the amount of scientific knowledge regarding the efficacy and safety of antihypertensive agents in children. However, the designs of many of these trials raise ethical questions related to the inclusion of placebo controls, a practice that has largely been abandoned in trials of antihypertensives in adults because of the well-known adverse consequences of untreated hypertension. This is an especially important issue in pediatric hypertension, as many hypertensive children have either secondary forms of hypertension or hypertension-induced target organ damage, potentially increasing the risk of harm during exposure to placebo. Against this background, and with a strong emphasis on protection of this vulnerable patient population, a strict set of conditions for use of placebos in pediatric antihypertensive trials is proposed. • the possibility of increased risk to both healthy research subjects and subjects with disease;• the need to obtain "informed assent" from older children and adolescents;• the possibility that research risks will be unequally distributed across the pediatric population (and the related issue that only a small number of children will have the opportunity to participate in research); and • how to recruit and compensate pediatric subjects without coercion. 4 -6 An additional ethical issue that has not received much attention in the literature is placebo use in pediatric clinical trials. Although guidelines issued by the American Academy of Pediatrics several years ago endorsed the use of placebo in limited circumstances in pediatric clinical trials, 7 these guidelines were issued before the recent increase in pediatric clinical trials, which has greatly increased the numbers of children with chronic illnesses involved in such research.Indeed, the ethics of placebo use in pediatric trials, especially those involving subjects with potentially significant illness, have recently been questioned. 8 Of all of the medications that the FDA has requested be studied in children as a result of the FDAMA, one of the largest categories is cardiovascular medications, particularly antihypertensives. 2 As of March 2003, at least 20 written requests have been issued by the FDA for studies of antihypertensive compounds in children, and manufacturers have responded to these requests with at least 15 pediatric clinical trials. Many of these industry-sponsored studies of antihypertensive agents have incorporated placebo controls to establish efficacy. These studies are being conducted at the same time that some investigators have called for the end of placebo use in adult hypertension research because of the well-known cardiovascular consequences of untreated hypertension in adults. 9 However, placebo use in pediatric antihypertensive trial...

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Pediatric use of antihypertensive medications: much more to learn

Cited by 31 publications

References 64 publications

Efficacy and safety of prolonged amlodipine treatment in hypertensive children

Efficacy and safety of prolonged amlodipine treatment in hypertensive children

Guidelines for Diagnosis and Management of Cardiovascular Sequelae in Kawasaki Disease (JCS 2013)

Ethics of Placebo Use in Pediatric Clinical Trials

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