We designed a study to determine the efficacy and safety of
amlodipine given once daily in the pediatric population. Twenty-one patients (mean age 13.1 years) with either essential (n=160) or renal (n=5)
hypertension, and newly diagnosed (n=15) or poorly controlled or intolerant on existing
antihypertensive therapy (n=6), were included. Patients received
amlodipine once daily at a starting mean dose of 0.07+/-0.04 mg/kg per day. The total daily dose of
amlodipine was increased 25%-50% every 5-7 days if the mean home blood pressure measurements (
HBPM) were above the 95th percentile for age and gender. A baseline followed by a repeat 24-h ambulatory
blood pressure monitor study (ABPM) was performed in 20 patients when the mean
HBPM was below the 95th percentile goal. The mean titrated dose required to control BP was 0.29+/-0.11 mg/kg per day for those < 13 years, 0.16+/-0.11 mg/kg per day for those > or = 13 years, 0.23+/-0.14 mg/kg per day for
essential, hypertension and 0.24+/-0.13 mg/kg per day for
renal hypertension. The ABPM demonstrated that
amlodipine provided effective BP control as primary
therapy in 14 essential patients. Adverse effects included
fatigue (n=6),
headache (n=5), facial
flushing (n=4),
dizziness (n=3),
edema (n=3),
abdominal pain (n=3),
chest pain (n=2),
nausea (n=1), and
vomiting (n=1). Quality of life appeared to improve during
therapy.
Amlodipine was an effective once daily
antihypertensive agent with an acceptable safety profile. Higher doses of
amlodipine were required for younger patients, and monotherapy was effective in patients with
essential hypertension.