Efficacy of amlodipine in pediatric patients with hypertension

We designed a study to determine the efficacy and safety of amlodipine give n 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 new ly diagnosed (n=15) or poorly controlled or intolerant on existing antihype rtensive therapy (n=6), were included. Patients received amlodipine once da ily at a starting mean dose of 0.07+/-0.04 mg/kg per day. The total daily d ose of amlodipine was increased 25%-50% every 5-7 days if the mean home blo od pressure measurements (HBPM) were above the 95th percentile for age and gender. A baseline followed by a repeat 24-h ambulatory blood pressure moni tor 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 f or those greater than or equal to 13 years, 0.23+/-0.14 mg/kg per day for e ssential, hypertension and 0.24+/-0.13 mg/kg per day for renal hypertension . The ABPM demonstrated that amlodipine provided effective BP control as pr imary therapy in 14 essential patients. Adverse effects included fatigue (n =6), headache (n=5), facial flushing (n=4), dizziness (n=3), edema (n=3), a bdominal pain (n=3), chest pain (n=2), nausea (n=1), and vomiting (n=1). Qu ality of life appeared to improve during therapy. Amlodipine was an effecti ve once daily antihypertensive agent with an acceptable safety profile. Hig her doses of amlodipine were required for younger patients, and monotherapy was effective in patients with essential hypertension.