PEDIATRICS Vol. 107 No. 3 March 2001, pp. 558-561
,
, and
From the * University of Tennessee College of Medicine,
Department of Pediatrics, Memphis, Tennessee;
Children's Hospital
of Philadelphia, Department of Pediatrics, Division of Clinical
Pharmacology and Therapeutics, Philadelphia, Pennsylvania; § Arkansas
Children's Hospital Research Center, Inc, Section of Clinical
Pharmacology, Little Rock, Arkansas;
Louisiana State University
Medical School, Department of Pediatrics, Shreveport, Louisiana; and
the # Section of Pharmacology and Toxicology, Children's Hospital
Research Foundation, Columbus, Ohio.
| The first 300 words of the full text of this article appear below. |
The testing of antihypertensive
medications in children is timely because physicians caring for
hypertensive children
especially pediatric nephrologists,
cardiologists, endocrinologists, and adolescent medicine physicians, as
well as clinical pharmacologists
have as therapeutic options almost no
approved drugs for children, and somewhat outdated official
recommendations.1,2 In the balance of this need lie the
problems inherent in using pediatric populations for clinical trials
a
problem that has been recognized by leaders in the pharmaceutical
industry. A representative of the pharmaceutical industry concurred
that a particularly difficult pediatric population are hypertensives.
The incidence (and prevalence) of hypertension in childhood is low,
between 2% and 5% in some series.1 Even in many of the
population groups in which numerous epidemiologic studies have shown
that adult hypertension is frequent
participants with diabetes
mellitus, obesity, certain racial groups (black, Native American,
Latino), and in families with essential hypertension
the prevalence of
hypertension during childhood is low, but blood pressure values may
progress over time to be hypertensive.2,3 Placebo control
and placebo arm of treatment trials are problematic because the only
children in whom recommendations for therapy exist are those whose
blood pressures are above the 95th percentile.2,3
The identification of hypertension is further beset by a considerable
number of technical issues, including white coat hypertension, appropriate cuff size for arm length or weight, height related norms,
current paucity of validation of ambulatory blood pressure measurements, and measurement devices in North American children, which
Korotkoff sounds to evaluate (4th or 5th) and at which ages, and
whether the 4th or 5th sound is more relevant in children under
13-years of age.4 Studies in children who are the
offspring of adult hypertensive participants have shown that
reproducible stress testing (eg, playing a video game at an
accelerating speed) may unmask a tendency for blood pressure elevation
for chronological
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